Therapeutic Index Final
January 10, 2017 | Author: hossainctg | Category: N/A
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Therapeutic Index
Beximco Pharmaceuticals Ltd.
T
H E R A P E U T I C
I
N D E X
Published in March 2004 Copyright © 2004 all rights reserved Compiled and Published by Medical Department Beximco Pharmaceuticals Ltd. Design and Computer Graphics by DTP, Medical Department Printed by Shuktara Printers, Gazipur PTG-235/02-04/5000 SHUK
O UR M ISSION
OUR MISSION ISSION
E
ach of our activities must benefit and add value to the common wealth of our society. We firmly believe that, in the final analysis we are accountable to each of the constituents with whom we interact; namely: our employees, our customers, our business associates, our fellow citizens and our shareholders. History Key milestones 1976
Registration of the company
1980
Started manufacturing and marketing of licensee products of Bayer AG of Germany and Upjohn Inc. of USA
1983
Launching its own products
1985
Listing in the Dhaka Stock Exchange (DSE) as a Public Limited Company (PLC)
1990
Commissioning of Basic Chemical unit
1992
Started export operation with Active Pharmaceutical Ingredients (APIs)
1993
First export market operation with Finished Pharmaceutical Products
1994-95 The first pharmaceutical company in the country to receive ‘National Export Trophy (Gold)’ 1996 Introduction of Sustained Release dosage form in the market vii
O U R
M I S S I O N
1997
Commissioning of Metered Dose Inhaler (MDI) plant and introduction of Suppository dosage form
1998
Introduction of Metered Dose Nasal Spray
1998-99 Received ‘National Export Trophy (Gold)’ 1999
UNICEF approval of BPL as an enlisted supplier
1999-00 Received ‘National Export Trophy (Gold)’ 2000
Contract manufacturing agreement of Metered Dose Inhaler (MDI) with Glaxo SmithKline
2001
Introduction of small volume parenteral products (Injectables) and Establishment of AnalgesicAntiinflammatory bulk-drug plant
2002
The first Bangladeshi company to supply pharmaceuticals to Raffles Hospital of Singapore
The Profile Corporate Headquarters : 17 Dhanmondi R/A, Road No. 2, Dhaka 1205, Bangladesh Operational Headquarter : 19 Dhanmondi R/A, Road No. 7, Dhaka 1205, Bangladesh Factory : Auspara, Tongi, Gazipur Business Lines : Manufacturing and marketing of pharmaceutical finished products and Active Pharmaceutical Ingredients (APIs) Overseas Offices and Associates : UK, USA, Pakistan, Nepal, Myanmar, Singapore, Kenya, Yemen. Export Outlets : Bhutan, Georgia, Germany, Hong Kong, Iran, Iraq, Kenya, Malaysia, Myanmar, Nepal, Pakistan, Russia, Singapore, South Korea, Taiwan, Thailand, Ukraine, Vietnam and Yemen. viii
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M I S S I O N
International Marketing In BPL we are proactive in our approach to aggressively search for new avenues in the international market place: Beximco Pharma is the pioneer in entering the CIS countries. BPL is the first pharmaceutical company in Bangladesh to receive National Export Trophy Gold in 1998. In Pakistan, BPL took proactive measures in launching its products with Multimedia CD-ROM replacing the age-old printed promotional materials. In Myanmar, BPL further consolidated its position by donating Medical Information Kiosks to the Myanmar Medical Association. Beximco Pharma is the only Bangladeshi pharmaceutical company operating in Singapore market- one of the most stringent and regulated markets in Asia. Beximco Pharma was the first company from Bangladesh to enter the African Market. We are delighted and proud of our pioneering achievements. More than that, we have probably fulfilled a national aspiration of turning an import dependent country into an exporter of quality medicines. Despite the fact that there is no incentive for pharmaceutical export in Bangladesh, till today, we have not deviated from our proactive and pioneering role in international marketing. Our journey that began amidst many obstacles has now expanded to nineteen countries. In 2002, BPL’s major emphasis in international marketing was to consolidate and grow in all its existing overseas markets by ensuring ix
O U R
M I S S I O N
sustainable competitive advantage over our competitors and competitive brands. In 2002, we were awarded a tender order for our Neoceptin R for the whole year’s consumption of Raffles Hospital- the most prestigious hospital in Singapore. We have also supplied our product in KK Women’s and Children’s Hospital in Singapore. In order to expand our product portfolio in Myanmar, we have launched liquid/bottle items by organizing a huge scientific seminar. We have supplied our products to Shaukat Khanum Memorial Cancer Hospital & Research Center and Aga Khan University Hospital- the two renowned institutions in Pakistan. In Kenya, we have started supplying to Mission for Essential Drugs and Supplies (MEDS)- the largest institution and Kenyatta Hospital -the largest hospital in Kenya. While consolidating in all our existing overseas markets, we are determined to continue deploying our efforts and resources to develop new overseas markets in Asia, Africa, and Europe. As a part of our ongoing new market exploration activities, in 2002 we participated in all major exhibitions held in Russia, Ukraine, Afghanistan and Nepal. For evaluating business opportunities in new overseas markets, we conducted market research in various markets in Asia and Europe. The Leading Health Care Company in Bangladesh Beximco Pharmaceuticals Ltd. is a member of the Beximco Group- the largest private sector business conglomerate of Bangladesh, comprising 8 divisions and over 22000 employees. BPL, the largest pharmaceutical as well as bulk drug manufacturer of x
O U R
M I S S I O N
Bangladesh started its journey back in 1980 with manufacturing and marketing of licensee products of Bayer AG, Germany and Upjohn Inc. of USA. BPL launched 6 of its own products in 1983. We strongly believe in high quality and cost-effective medicine. We are proud to become first enlisted supplier to international bodies like UNICEF, UNDP, WHO and ICDDR,B. The National Recognition for Excellence In addition to local market, BPL’s export activities are there in nineteen countries of three continents- Asia, Europe and Africa. For its outstanding export performance, BPL received Bangladesh’s highest award for export, the National Export Trophy, Gold in 1994-95. BPL is the first pharmaceutical company in Bangladesh to receive such an award. BPL was also awarded National Export Trophy Gold for two consecutive years 1998-1999 & 1999-2000. BPL is the record three times winner of this national highest recognition for export. Committed to Serve BPL’s commitment is to always offer the best, both in quality and services to its customers. Quality is the measure of excellence in the field of pharmaceutical products. BPL feels that it has an incalculable social liability of providing safe, efficacious and highest quality drugs. Equipped with the latest & the most advanced state-of-the-art technologies BPL team is committed to serve its customers. Through the highest quality drugs BPL has succeeded in gaining the confidence & trust of doctors & patients all over the country.
xi
O U R
M I S S I O N
BPL- A Company with Vision for Tomorrow BPL has transformed its activities, culture, style and philosophy to meet the demands of the new millennium. Business diversifications that are strategically important for a sustained growth are results of its vision of the future. Several new bulk drug facilities are being developed to backward integrate their high volume products. A USFDA standard multi-million dollar pharmaceutical formulation plant is nearing completion. This would be one of the most modern plants in this region. Our Differential Edge • World class manufacturing facilities • Highest cGMP standards • Outstanding product quality • Sophisticated formulation technology • Diversified and hightech dosage forms & products • Significant investment in R&D • Excellent customer services • Responsible care for the environment • Commitment to the people & the society
xii
CONTENTS
IN
BRAND N AME
C O N T E N T S
BRAND NAME
I N
B R A N D
N A M E
G ENERIC NAME
Aeronid Inhaler Alendon Tablet Alphin DS Tablet Amdocal Tablet Anustat Ointment
Budesonide BP Alendronate Sodium BP Albendazole USP Amlodipine Besylate INN Cinchocaine Hydrochloride BP, Hydrocortisone BP, Neomycin Sulphate USP and Esculin Apresin Tablet Fluphenazine Hydrochloride BP and Nortriptyline Hydrochloride BP Arbit Tablet Irbesartan INN Aristocal Tablet Calcium Carbonate BP Aristoferon Syrup Ferrous Sulphate BP Aristofol-Fe Tablet Ferrous Fumarate BP and Folic Acid USP Aristoplex Syrup Vitamin B Complex Aristovit-B Tablet Vitamin B Complex Aristovit-M Tablet Multivitamin and Mineral Aristovit-X Tablet Antioxidant, Vitamin, and Mineral Arixon IV/IM Injection Ceftriaxone Sodium USP Arlin Tablet/Suspension Linezolid INN Ascobex Tablet Ascorbic Acid USP Atova Tablet Atorvastatin Calcium INN Atrizin Tablet/Syrup Cetirizine Hydrochloride BP Avastin Tablet Simvastatin USP Avidro Tablet Pizotifen Malate BP Avifanz Tablet Efavirenz INN Avifix Tablet Nelfinavir Mesylate INN Avilam Tablet Lamivudine INN Avitron V Tablet Thiamine Hydrochloride USP Axodin Tablet Fexofenadine Hydrochloride INN Azithrocin Capsule Azithromycin USP /Tablet/Suspension Azmasol Inhaler Salbutamol BP Bexidal Tablet Mebhydrolin Napadisylate BPC Bexitrol-F Inhaler Fluticasone Propionate BP and Salmeterol Xinafoate INN Bexitrol Inhaler Salmeterol Xinafoate INN
xv
1 6 9 11 14
16 18 20 22 24 26 28 29 31 33 36 39 41 46 48 51 53 58 64 68 70 74 77 80 81 84
C O N T E N T S
I N
B R A N D
N A M E
B RAND NAME
G ENERIC NAME
Bextrum Tablet
High potency Multivitamin and Multimineral Salbutamol Sulphate BP
87
Captopril USP Beta Carotene, Ascorbic Acid USP and dl-alpha-Tocopheryl Acetate Carbonyl Iron INN, Folic Acid BP and Zinc Sulphate Monohydrate USP Cefalexin BP
91 94
Bronkolax Tablet /Syrup Cardopril Tablet Carocet Tablet Carofol-Z Capsule Cephalen Capsule /Suspension Cerivin Tablet Clobex Capsule/Syrup Cosmotrin Cream Cox B Capsule Curin Tablet Decacycline Capsule Decomit Inhaler Decomit Nasal Spray Deflux Tablet /Suspension /Paediatric Drops Dextromethorphan Syrup Diactin Tablet Diaglit Tablet Diapro Tablet Diaryl Tablet Diavix Tablet Dilapress Tablet Ecotrim Cream Efol-ER Capsule
Enaril Tablet Epilep Tablet Eplon Capsule
89
96 98
Vinpocetine INN Cloxacillin Sodium BP Tretinoin USP Celecoxib INN Levocetrizine Dihydrochloride INN Tetracycline Hydrochloride BP Beclomethasone Dipropionate BP Beclomethasone Dipropionate BP Domperidone Maleate BP/ Domperidone BP
101 103 105 107 112 114 116 119 121
Dextromethorphan Hydrobromide BP
123
Glipizide BP Pioglitazone Hydrochloride INN Gliclazide BP Glimepiride INN Lamivudine INN and Zidovudine USP Carvedilol BP Econazole Nitrate BP and Triamcinolone Acetonide BP Ferrous Sulphate BP, Folic Acid USP and Zinc Sulphate Monohydrate USP Enalapril Maleate USP Carbamazepine BP Zaleplon INN
124 130 133 136 140 144 147
xvi
149
152 155 158
C O N T E N T S
I N
B R A N D
N A M E
BRAND NAME
GENERIC N AME
Etrocin Tablet /Suspension Evo Tablet Fertil Tablet Fibril Capsule Filmet Tablet /Suspension Flatameal-DS Tablet /Suspension
Erythromycin USP
162
Levofloxacin Hemihydrate INN Clomiphene Citrate USP Gemfibrozil USP Metronidazole BP/Metronidazole Benzoate BP Aluminium Hydroxide Gel USP, Magnesium Hydroxide BP and Simethicone USP Flucloxacillin Sodium BP Vitamin E USP Polyethylene Glycol 3350 USP NF Flupentixol Dihydrochloride BP and Melitracen Hydrochloride INN Nystatin BP Nitrofurazone USP Sodium Fusidate BP and Hydrocortisone Acetate BP Sucralfate USP Gentamicin Sulphate BP Ferrous Sulphate BP and Folic Acid BP Cinnarizine BP Metformin Hydrochloride BP Cephradine BP
166 168 171 173
Cephradine USP Ipratropium Bromide BP Pefloxacin Mesilate BP Clobazam BP Aluminium Hydroxide Gel USP and Magnesium Hydroxide BP Aminophylline BP Tramadol Hydrochloride BP Doxycycline Hydrochloride BP
204 207 210 213 215
Flubex Capsule/Syrup Formula E Tablet Frelax Powder Frenxit Tablet Fungistin Suspension Furasep Cream Fusidic Plus Ointment Gastalfet Tablet Gentosep Cream Hefolin SR Capsule Inarzin Tablet Informet LA Tablet Intracef Capsule /Suspension /Paediatric Drops Intracef Injection Ipramid Inhaler Isofloxin Tablet Keolax Tablet Lactameal Tablet /Suspension Larnox LA Tablet Lucidol Capsule Megadox Capsule
xvii
175
176 178 181 184 186 188 189 191 193 194 196 198 201
216 219 222
C O N T E N T S
I N
B R A N D
N A M E
BRAND NAME
G ENERIC NAME
Megatrim DS Tablet
Trimethoprim BP and Sulfamethoxazole BP Trimethoprim BP and Sulfamethoxazole BP Pyrantel Pamoate USP
225
Fluoxetine Hydrochloride BP Desloratadine INN Isosorbide Mononitrate BP Montelucast Sodium INN Paracetamol BP
231 234 237 239 244
Oxymetazoline Hydrochloride USP Nalidixic Acid BP Clarithromycin USP, Omeprazole BP and Metronidazole BP Diltiazem Hydrochloride USP Ranitidine Hydrochloride USP
246 248 250
Simethicone USP
256
Ciprofloxacin Hydrochloride USP Lisinopril USP Clotrimazole BP Clotrimazole BP Bromazepam BP Permethrin INN Naproxen USP Clopidogrel Bisulfate INN Fluconazole INN
258 263 269 271 273 275 277 280 282
Esomeprazole Magnesium Trihydrate INN Amiodarone Hydrochloride BP Diphenhydramine Hydrochloride BP
286
Megatrim Suspension Melphin Tablet /Suspension Modipran Capsule Momento Tablet/Syrup Monate Tablet Monocast Tablet Napa Tablet/Syrup /Suppository /Paediatric drops Nazolin Nasal Spray Nebactil Suspension Neo Kit Neocard Tablet Neoceptin R Tablet /Syrup Neodrop Paediatric Drops Neofloxin Tablet Neopril Tablet Neosten Cream Neosten VT Nightus Tablet Noscab Cream Nuprafen Tablet Odrel Tablet Omastin Capsule /Suspension Opton Tablet Pacet Tablet Pedeamin Syrup
xviii
225 229
252 254
289 292
C O N T E N T S
I N
B R A N D
N A M E
BRAND NAME
G ENERIC NAME
Pregvit Capsule
Ferrous Sulphate BP, Folic Acid USP, Thiamine Mononitrate USP, Riboflavin USP, Nicotinamide USP, Pyridoxine Hydrochloride USP & Ascorbic Acid USP Repaglinide USP Loratadine INN Ramipril BP Omeprazole BP Losartan Potassium INN Finasteride USP Lansoprazole USP Rofecoxib INN Finasteride USP Glucosamine Hydrochloride USP Tizanidine Hydrochloride INN Spironolactone BP and Frusemide BP lbuprofen BP
294
Clarithromycin USP Mebeverine Hydrochloride BP Clozapine BP Lactulose Solution BP Sibutramine Hydrochloride Monohydrate INN Hyoscine Butylbromide BP Sparfloxacin INN Bromhexine Hydrochloride BP Tamoxifen Citrate BP Drotaverine Hydrochloride INN Terbinafine Hydrochloride INN Ketotifen Fumarate BP Cefixime Trithydrate USP
330 333 335 339 341
Lamivudine INN, Zidovudine USP and Nevirapine INN
361
Premil Tablet Pretin Tablet Primace Capsule Proceptin-20 Capsule Prosan Tablet Prosfin Tablet Protolan Capsule Recox Tablet Recur Tablet Reflon Tablet Relentus Tablet Resitone Tablet Reumafen Tablet /Suspension Rolacin Tablet Rostil Tablet Sensipin Tablet Serelose Solution Sibulin Capsule Spanil Tablet Sparlin Tablet Spulyt Tablet/Syrup Tamona Tablet Taverin Tablet Terbex Cream/Tablet Tofen Tablet/Syrup Triocim Capsule /Suspension Triovix Tablet
xix
296 300 302 305 308 310 313 316 319 321 323 325 327
344 345 347 349 353 355 357 359
C O N T E N T S
BRAND NAME Tripec Syrup
Tycil Capsule /Suspension /Paediatric Drops Tycil DS Suspension Tynisol Drops Ultrafen Tablet /Suppository/Gel Uricon Tablet Uroflo Capsule Valcap Capsule V-Cox Tablet Xynofen-100 SR Capsule Yamadin Tablet Zedex-DS Syrup Zocil Tablet Zukast Tablet Zymet Tablet
I N
B R A N D
N A M E
GENERIC NAME Guaifenesin BP, Pseudoephedrine Hydrochloride BP and Triprolidine Hydrochloride BP Amoxicillin Trihydrate BP
364
Amoxicillin Trihydrate BP Multivitamin Diclofenac Sodium BP/Diclofenac Diethylamine BP Oxybutynin Chloride USP Tamsulosin Hydrochloride INN Valsartan INN Valdecoxib INN Ketoprofen BP Famotidine USP Zinc Sulphate Monohydrate USP Cilostazol INN Zafirlukast INN Pancreatin BP
366 369 371
xx
366
374 377 379 382 386 389 391 393 395 401
CONTENTS
IN
THERAPEUTIC GROUP
C O N T E N T S
I N
BRAND NAME Analgesic & Antipyretic Napa Tablet/Syrup /Suppository /Paediatric drops
T H E R A P E U T I C
G R O U P
G ENERIC NAME Paracetamol
244
Anthelmintic Alphin DS Tablet Melphin Tablet/Suspension
Albendazole Pyrantel Pamoate
9 229
Anti-acne preparation Cosmotrin Cream
Tretinoin
105
Anti-osteoarthritic preparation Reflon Tablet Glucosamine Hydrochloride Anti-asthma preparation Aeronid Inhaler Azmasol Inhaler Bexitrol-F Inhaler
Ipramid Inhaler Larnox LA Tablet
Budesonide Salbutamol Fluticasone Propionate and Salmeterol Xinafoate Salmeterol Xinafoate Salbutamol Sulphate Beclomethasone Dipropionate Ipratropium Bromide Aminophylline
Anti-cancer preparation Tamona Tablet
Tamoxifen Citrate
Bexitrol Inhaler Bronkolax Tablet/Syrup Decomit Nasal Spray
Antidepressant Apresin Tablet
Fluphenazine Hydrochloride and Nortriptyline Hydrochloride
xxiii
321
1 77 81 84 89 119 207 216
349
16
C O N T E N T S
I N
T H E R A P E U T I C
G R O U P
BRAND NAME
G ENERIC NAME
Frenxit Tablet
184
Modipran Capsule Sensipin Tablet
Flupentixol Dihydrochloride and Melitracen Hydrochloride Fluoxetine Hydrochloride Clozapine
Antidiabetic preparation Diactin Tablet Diaglit Tablet Diapro Tablet Diaryl Tablet Informet LA Tablet Premil Tablet
Glipizide Pioglitazone Hydrochloride Gliclazide Glimepiride Metformin Hydrochloride Repaglinide
124 130 133 136 198 296
Domperidone Maleate
121
Carbamazepine
155
Anti-emetic preparation Deflux Tablet/Suspension /Paediatric Drops Anti-epileptic preparation Epilep Tablet
Anti-haemorrhoidal preparation Anustat Ointment Cinchocaine Hydrochloride, Hydrocortisone, Neomycin Sulphate and Esculin Anti-histamine preparation Atrizin Tablet/Syrup Axodin Tablet Bexidal Tablet Curin Tablet Momento Tablet/Syrup Pedeamin Syrup Pretin Tablet
Cetirizine Hydrochloride Fexofenadine Hydrochloide Mebhydrolin Napadisylate Levocetrizine Dihydrochloride Desloratadine Diphenhydramine Hydrochloride Loratadine
xxiv
231 335
14
46 70 80 112 234 292 300
C O N T E N T S
I N
B RAND NAME Anti-HIV preparation Avifanz Tablet Avifix Tablet Avilam Tablet Diavix Tablet Triovix Tablet
T H E R A P E U T I C
G R O U P
GENERIC NAME
Efavirenz Nelfinavir Mesylate Lamivudine Lamivudine and Zidovudine Lamivudine, Zidovudine and Nevirapine
53 58 64 140 361
Anti-microbial preparation Antibacterials Arixon IV/IM Injection Arlin Tablet/Suspension Azithrocin Capsule/Tablet /Suspension Cephalen Capsule /Suspension Clobex Capsule/Syrup Decacycline Capsule Etrocin Tablet/Suspension Evo Tablet Filmet Tablet/Suspension Flubex Capsule/Syrup Furasep Cream Fusidic Plus Ointment Gentosep Cream Intracef Capsule /Suspension /Paediatric Drops Intracef Injection Isofloxin Tablet Megadox Capsule
Ceftriaxone Sodium Linezolid Azithromycin
33 36 74
Cephalexin
98
Cloxacillin Sodium Tetracycline Hydrochloride Erythromycin Levofloxacin Hemihydrate Metronidazole/ Metronidazole Benzoate Flucloxacillin Sodium Nitrofurazone Sodium Fusidate and Hydrocortisone Acetate Gentamicin Sulphate Cephradine
103 114 162 166 173
Cephradine Pefloxacin Mesilate Doxycycline Hydrochloride
204 210 222
xxv
176 188 189 193 201
C O N T E N T S
BRAND NAME
I N
B R A N D
N A M E
G ENERIC NAME
Aeronid Inhaler Alendon Tablet Alphin DS Tablet Amdocal Tablet Anustat Ointment
Budesonide BP Alendronate Sodium BP Albendazole USP Amlodipine Besylate INN Cinchocaine Hydrochloride BP, Hydrocortisone BP, Neomycin Sulphate USP and Esculin Apresin Tablet Fluphenazine Hydrochloride BP and Nortriptyline Hydrochloride BP Arbit Tablet Irbesartan INN Aristocal Tablet Calcium Carbonate BP Aristoferon Syrup Ferrous Sulphate BP Aristofol-Fe Tablet Ferrous Fumarate BP and Folic Acid USP Aristoplex Syrup Vitamin B Complex Aristovit-B Tablet Vitamin B Complex Aristovit-M Tablet Multivitamin and Mineral Aristovit-X Tablet Antioxidant, Vitamin, and Mineral Arixon IV/IM Injection Ceftriaxone Sodium USP Arlin Tablet/Suspension Linezolid INN Ascobex Tablet Ascorbic Acid USP Atova Tablet Atorvastatin Calcium INN Atrizin Tablet/Syrup Cetirizine Hydrochloride BP Avastin Tablet Simvastatin USP Avidro Tablet Pizotifen Malate BP Avifanz Tablet Efavirenz INN Avifix Tablet Nelfinavir Mesylate INN Avilam Tablet Lamivudine INN Avitron V Tablet Thiamine Hydrochloride USP Axodin Tablet Fexofenadine Hydrochloride INN Azithrocin Capsule Azithromycin USP /Tablet/Suspension Azmasol Inhaler Salbutamol BP Bexidal Tablet Mebhydrolin Napadisylate BPC Bexitrol-F Inhaler Fluticasone Propionate BP and Salmeterol Xinafoate INN Bexitrol Inhaler Salmeterol Xinafoate INN
xv
1 6 9 11 14
16 18 20 22 24 26 28 29 31 33 36 39 41 46 48 51 53 58 64 68 70 74 77 80 81 84
C O N T E N T S
I N
B R A N D
N A M E
B RAND NAME
G ENERIC NAME
Bextrum Tablet
High potency Multivitamin and Multimineral Salbutamol Sulphate BP
87
Captopril USP Beta Carotene, Ascorbic Acid USP and dl-alpha-Tocopheryl Acetate Carbonyl Iron INN, Folic Acid BP and Zinc Sulphate Monohydrate USP Cefalexin BP
91 94
Bronkolax Tablet /Syrup Cardopril Tablet Carocet Tablet Carofol-Z Capsule Cephalen Capsule /Suspension Cerivin Tablet Clobex Capsule/Syrup Cosmotrin Cream Cox B Capsule Curin Tablet Decacycline Capsule Decomit Inhaler Decomit Nasal Spray Deflux Tablet /Suspension /Paediatric Drops Dextromethorphan Syrup Diactin Tablet Diaglit Tablet Diapro Tablet Diaryl Tablet Diavix Tablet Dilapress Tablet Ecotrim Cream Efol-ER Capsule
Enaril Tablet Epilep Tablet Eplon Capsule
89
96 98
Vinpocetine INN Cloxacillin Sodium BP Tretinoin USP Celecoxib INN Levocetrizine Dihydrochloride INN Tetracycline Hydrochloride BP Beclomethasone Dipropionate BP Beclomethasone Dipropionate BP Domperidone Maleate BP/ Domperidone BP
101 103 105 107 112 114 116 119 121
Dextromethorphan Hydrobromide BP
123
Glipizide BP Pioglitazone Hydrochloride INN Gliclazide BP Glimepiride INN Lamivudine INN and Zidovudine USP Carvedilol BP Econazole Nitrate BP and Triamcinolone Acetonide BP Ferrous Sulphate BP, Folic Acid USP and Zinc Sulphate Monohydrate USP Enalapril Maleate USP Carbamazepine BP Zaleplon INN
124 130 133 136 140 144 147
xvi
149
152 155 158
C O N T E N T S
I N
B R A N D
N A M E
BRAND NAME
G ENERIC NAME
Etrocin Tablet /Suspension Evo Tablet Fertil Tablet Fibril Capsule Filmet Tablet /Suspension Flatameal-DS Tablet /Suspension
Erythromycin USP
162
Levofloxacin Hemihydrate INN Clomiphene Citrate USP Gemfibrozil USP Metronidazole BP/Metronidazole Benzoate BP Aluminium Hydroxide Gel USP, Magnesium Hydroxide BP and Simethicone USP Flucloxacillin Sodium BP Vitamin E USP Polyethylene Glycol 3350 USP NF Flupentixol Dihydrochloride BP and Melitracen Hydrochloride INN Nystatin BP Nitrofurazone USP Sodium Fusidate BP and Hydrocortisone Acetate BP Sucralfate USP Gentamicin Sulphate BP Ferrous Sulphate BP and Folic Acid BP Cinnarizine BP Metformin Hydrochloride BP Cephradine BP
166 168 171 173
Cephradine USP Ipratropium Bromide BP Pefloxacin Mesilate BP Clobazam BP Aluminium Hydroxide Gel USP and Magnesium Hydroxide BP Aminophylline BP Tramadol Hydrochloride BP Doxycycline Hydrochloride BP
204 207 210 213 215
Flubex Capsule/Syrup Formula E Tablet Frelax Powder Frenxit Tablet Fungistin Suspension Furasep Cream Fusidic Plus Ointment Gastalfet Tablet Gentosep Cream Hefolin SR Capsule Inarzin Tablet Informet LA Tablet Intracef Capsule /Suspension /Paediatric Drops Intracef Injection Ipramid Inhaler Isofloxin Tablet Keolax Tablet Lactameal Tablet /Suspension Larnox LA Tablet Lucidol Capsule Megadox Capsule
xvii
175
176 178 181 184 186 188 189 191 193 194 196 198 201
216 219 222
C O N T E N T S
I N
B R A N D
N A M E
BRAND NAME
G ENERIC NAME
Megatrim DS Tablet
Trimethoprim BP and Sulfamethoxazole BP Trimethoprim BP and Sulfamethoxazole BP Pyrantel Pamoate USP
225
Fluoxetine Hydrochloride BP Desloratadine INN Isosorbide Mononitrate BP Montelucast Sodium INN Paracetamol BP
231 234 237 239 244
Oxymetazoline Hydrochloride USP Nalidixic Acid BP Clarithromycin USP, Omeprazole BP and Metronidazole BP Diltiazem Hydrochloride USP Ranitidine Hydrochloride USP
246 248 250
Simethicone USP
256
Ciprofloxacin Hydrochloride USP Lisinopril USP Clotrimazole BP Clotrimazole BP Bromazepam BP Permethrin INN Naproxen USP Clopidogrel Bisulfate INN Fluconazole INN
258 263 269 271 273 275 277 280 282
Esomeprazole Magnesium Trihydrate INN Amiodarone Hydrochloride BP Diphenhydramine Hydrochloride BP
286
Megatrim Suspension Melphin Tablet /Suspension Modipran Capsule Momento Tablet/Syrup Monate Tablet Monocast Tablet Napa Tablet/Syrup /Suppository /Paediatric drops Nazolin Nasal Spray Nebactil Suspension Neo Kit Neocard Tablet Neoceptin R Tablet /Syrup Neodrop Paediatric Drops Neofloxin Tablet Neopril Tablet Neosten Cream Neosten VT Nightus Tablet Noscab Cream Nuprafen Tablet Odrel Tablet Omastin Capsule /Suspension Opton Tablet Pacet Tablet Pedeamin Syrup
xviii
225 229
252 254
289 292
C O N T E N T S
I N
BRAND NAME
T H E R A P E U T I C
G R O U P
G ENERIC NAME
Anti-microbial preparation Megatrim DS Tablet
Trimethoprim and Sulfamethoxazole Megatrim Suspension Trimethoprim and Sulfamethoxazole Nebactil Suspension Nalidixic Acid Neo Kit Clarithromycin, Omeprazole and Metronidazole Neofloxin Tablet Ciprofloxacin Hydrochloride Rolacin Tablet Clarithromycin Sparlin Tablet Sparfloxacin Triocim Capsule/Suspension Cefixime Trihydrate Tycil Capsule/Suspension Amoxicillin Trihydrate /Paediatric Drops Tycil DS Suspension Amoxicillin Trihydrate Antifungals Ecotrim Cream
225 225 248 250 258 330 345 359 366 366
Econazole Nitrate and Triamcinolone Acetonide Nystatin Clotrimazole Clotrimazole Fluconazole
147
Terbinafine Hydrochloride
355
Antidermatophytes Noscab Cream
Permethrin
275
Anti-migraine preparation Avidro Tablet
Pizotifen Malate
Anti-obesity preparation Sibulin Capsule
Sibutramine Hydrochloride
Fungistin Suspension Neosten Cream Neosten VT Omastin Capsules /Suspension Terbex Cream/Tablet
xxvi
186 269 271 282
51
341
C O N T E N T S
I N
B R A N D
N A M E
BRAND NAME
GENERIC N AME
Pregvit Capsule
Ferrous Sulphate BP, Folic Acid USP, Thiamine Mononitrate USP, Riboflavin USP, Nicotinamide USP, Pyridoxine Hydrochloride USP & Ascorbic Acid USP Repaglinide USP Loratadine INN Ramipril BP Omeprazole BP Losartan Potassium INN Finasteride USP Lansoprazole USP Rofecoxib INN Finasteride USP Glucosamine Hydrochloride USP Tizanidine Hydrochloride INN Spironolactone BP and Frusemide BP lbuprofen BP
294
Clarithromycin USP Mebeverine Hydrochloride BP Clozapine BP Lactulose Solution BP Sibutramine Hydrochloride Monohydrate INN Hyoscine Butylbromide BP Sparfloxacin INN Bromhexine Hydrochloride BP Tamoxifen Citrate BP Drotaverine Hydrochloride INN Terbinafine Hydrochloride INN Ketotifen Fumarate BP Cefixime Trithydrate USP
330 333 335 339 341
Lamivudine INN, Zidovudine USP and Nevirapine INN
361
Premil Tablet Pretin Tablet Primace Capsule Proceptin-20 Capsule Prosan Tablet Prosfin Tablet Protolan Capsule Recox Tablet Recur Tablet Reflon Tablet Relentus Tablet Resitone Tablet Reumafen Tablet /Suspension Rolacin Tablet Rostil Tablet Sensipin Tablet Serelose Solution Sibulin Capsule Spanil Tablet Sparlin Tablet Spulyt Tablet/Syrup Tamona Tablet Taverin Tablet Terbex Cream/Tablet Tofen Tablet/Syrup Triocim Capsule /Suspension Triovix Tablet
xix
296 300 302 305 308 310 313 316 319 321 323 325 327
344 345 347 349 353 355 357 359
C O N T E N T S
I N
BRAND NAME Antioxidant Carocet Tablet
T H E R A P E U T I C
G R O U P
G ENERIC NAME
Beta Carotene, Ascorbic Acid and dl-alpha-Tocopheryl Acetate
Anti-platelet aggregation preparation Odrel Tablet Clopidogrel Bisulphate Anti-resorptive preparation Alendon Tablet Alendronate Sodium Anti-spasmodic Rostil Tablet Spanil Tablet Taverin Tablet Uricon Tablet
94
280
6
Mebeverine Hydrochloride Hyoscine Butylbromide Drotaverine Hydrochloride Oxybutynin Choloride
333 344 353 374
Dextromethorphan Hydrobromide Bromhexine Hydrochloride Guaifenesin, Pseudoephedrine & Triprolidine
123
Anxiolytics preparation Eplon Capsule Keolax Tablet Nightus Tablet
Zaleplon Clobazam Bromazepam
158 213 273
Asthma Prophylactic Monocast Tablet Tofen Tablet/Syrup Zukast Tablet
Montelukast Sodium Ketotifen Fumarate Zafirlukast
239 357 395
Cardiovascular preparation Amdocal Tablet Amlodipine Besylate Arbit Tablet Irbesartan Cardopril Tablet Captopril
11 18 91
Antitussive Dextromethorphan Syrup Spulyt Tablet/Syrup Tripec Syrup
xxvii
347 364
C O N T E N T S
I N
B R A N D
N A M E
BRAND NAME
G ENERIC NAME
Tripec Syrup
Guaifenesin BP, Pseudoephedrine Hydrochloride BP and Triprolidine Hydrochloride BP Amoxicillin Trihydrate BP
364
Amoxicillin Trihydrate BP Multivitamin Diclofenac Sodium BP/Diclofenac Diethylamine BP Oxybutynin Chloride USP Tamsulosin Hydrochloride INN Valsartan INN Valdecoxib INN Ketoprofen BP Famotidine USP Zinc Sulphate Monohydrate USP Cilostazol INN Zafirlukast INN Pancreatin BP
366 369 371
Tycil Capsule /Suspension /Paediatric Drops Tycil DS Suspension Tynisol Drops Ultrafen Tablet /Suppository/Gel Uricon Tablet Uroflo Capsule Valcap Capsule V-Cox Tablet Xynofen-100 SR Capsule Yamadin Tablet Zedex-DS Syrup Zocil Tablet Zukast Tablet Zymet Tablet
xx
366
374 377 379 382 386 389 391 393 395 401
THERAPEUTIC I NDEX
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Aeronid ® Inhaler
Description Budesonide BP, the active ingredient of Aeronid Inhaler, is a corticosteroid designated that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic-mediated inflammation. These antiinflammatory actions of budesonide contribute to their efficacy in asthma. Indications Aeronid Inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and paediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma, many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. Aeronid Inhaler is NOT indicated for the relief of acute bronchospasm. Dosage and Administration Aeronid Inhaler should be administered by the orally inhaled route in asthmatic patients age 6 years and older. Individual patients will experience a variable onset and degree of symptom relief. Generally, Aeronid Inhaler has a relatively rapid onset of action for an inhaled corticosteroid. Improvement in asthma control following inhaled administration of Aeronid Inhaler can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks, or longer. The safety and efficacy of Aeronid Inhaler when administered in excess of recommended doses have not been established. The recommended starting dose and the highest recommended dose of Aeronid Inhaler, based on prior asthma therapy, are listed in the following table. 1
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Recommended Starting Dose
Highest Recommended Dose
Bronchodilators alone
200 to 400 µg twice daily
400 µg twice daily
Inhaled Corticosteroids*
200 to 400 µg twice daily
800 µg twice daily
Oral Corticosteroids
400 to 800 µg twice daily
800 µg twice daily
Bronchodilators alone
200 µg twice daily
400 µg twice daily
Inhaled Corticosteroids*
200 to 400 µg twice daily
400 µg twice daily
Oral Corticosteroids
The highest recommended dose in children is 400 µg twice daily
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*In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids, dosing with Aeronid Inhaler 200 µg or 400 µg once daily may be considered. Aeronid Inhaler can be administered once daily either in the morning or in the evening.
If the once-daily treatment with Aeronid Inhaler does not provide adequate control of asthma symptoms, the total daily dose should be increased and/or administered in divided doses. Patients Maintained on Chronic Oral Corticosteroids Initially, Aeronid Inhaler should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. The next reduction is made after an interval of one or two weeks, depending on the response of the patient. Generally, these decrements should not exceed 2.5 mg of prednisone or its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral corticosteroids, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency. During withdrawal, some patients may experience symptoms of systemic corticosteroid 2
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withdrawal, e.g., joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with Aeronid Inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid dose should be increased temporarily and thereafter withdrawal should be continued more slowly. During periods of stress or a severe asthma attack, transferred patients may require supplementary treatment with systemic corticosteroids. Contraindication Budesonide inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to Budesonide contraindicates the use of Aeronid Inhaler. Precautions During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function. Aeronid Inhaler will often permit control of asthma symptoms with less suppression of hypothalamic-pituitary-adrenal (HPA) function than therapeutically equivalent oral doses of prednisone. Since budesonide is absorbed into the circulation and can be systemically active at higher doses, the full beneficial effects of Aeronid Inhaler in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Since individual sensitivity to effects on cortisol production exists, physicians should consider this fact when prescribing Aeronid Inhaler. Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with these drugs should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. 3
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It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher doses. If such changes occur, Aeronid Inhaler should be reduced slowly, consistent with accepted procedures for management of asthma symptoms and for tapering of systemic steroids. A reduction of growth velocity in children or teenagers may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment. Physicians should closely follow the growth of all paediatric patients taking corticosteroids by any route and weigh the benefits of corticosteroid therapy and asthma control against the possibility of growth suppression. Although patients in clinical trials have received Aeronid Inhaler on a continuous basis for periods of 1 to 2 years, the long-term local and systemic effects of Aeronid Inhaler in human subjects are not completely known. In particular, the effects resulting from chronic use of Aeronid Inhaler on developmental or immunological processes in the mouth, pharynx, trachea, and lung are unknown. In clinical trials with Aeronid Inhaler, localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with Aeronid Inhaler therapy, but at times therapy with Aeronid Inhaler may need to be temporarily interrupted under close medical supervision. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral or parasitic infections; or ocular herpes simplex. Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of inhaled corticosteroids. Side Effects The following adverse reactions were reported in patients treated with Aeronid Inhaler. 4
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General : Headache, flu-like syndrome, pain, back pain, fever, neck pain, asthenia; Respiratory system : Respiratory tract infections, pharyngitis, sinusitis, rhinitis, voice alteration, cough aggravation; Digestive System : Oral candidiasis, dyspepsia, gastroenteritis, nausea, abdominal pain, dry mouth, vomiting; Metabolic and Nutritional : Weight gain; Musculoskeletal : Fracture, myalgia, arthralgia; Nervous system : Syncope, hypertonia, migraine; Skin : Ecchymosis; Psychiatric : Insomnia; Resistance Mechanisms : Infection; Special Senses : Taste perversion. Paediatric Studies There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults. Adverse event reports from other sources : Rare adverse events reported include immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema and bronchospasm; symptoms of hypocorticism and hypercorticism; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety and psychosis. Pharmaceutical Precautions Pressurized canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30o C. Keep away from eyes and children. Commercial Pack Aeronid 100 Inhaler : Each canister contains 200 metered doses, each containing 100 µg Budesonide BP. Aeronid 200 Inhaler : Each canister contains 200 metered doses, each containing 200 µg Budesonide BP.
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Alendon® Tablet
Description Alendon is a preparation of Alendronic Acid, a biphosphonate used in the treatment and prevention of osteoporosis in post-menopausal women. Indications Alendon is indicated for: ♦ Treatment and prevention of osteoporosis in post-menopausal women ♦
For the treatment of osteoporosis, Alendon increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures)
♦
For the prevention of osteoporosis, Alendon may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture
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Treatment to increase bone mass in men with osteoporosis
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Treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D
♦
Treatment of Paget’s disease of bone in men and women
Dosage and Administration Treatment of osteoporosis in postmenopausal women The recommended dose is one Alendon 70 tablet (70 mg) once weekly or one Alendon tablet (10 mg) once daily. Treatment to increase bone mass in men with osteoporosis The recommended dose is one Alendon tablet (10 mg) once daily. Alternatively, one Alendon 70 tablet (70 mg) once weekly may be considered. 6
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Prevention of osteoporosis in postmenopausal women The recommended dose is 35 mg once weekly or 5 mg once daily. The safety of treatment and prevention of osteoporosis with Alendronic Acid has been studied for up to 7 years. Treatment of glucocorticoid-induced osteoporosis in men and women The recommended dose is 5 mg once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dose is 10 mg once daily. Paget’s disease of bone in men and women The recommended treatment regimen is 40 mg once a day for six months. Mode of Administration Swallow the tablet with a full glass of water at least 30 minutes before breakfast (and any other oral medication) on empty stomach. Patients should remain stand or sit upright for at least 30 minutes after taking the tablet and should not be down before eating the first meal of the day. Do not take the tablet at bedtime. Hypocalcemia should be corrected before starting the therapy. Precautions Use in elderly : No dosage adjustment is required for elderly patients. Because in clinical study there was no evidence of age-related differences in the efficacy or safety profiles of Alendronic Acid. Children : It is not recommended for use. Pregnant women : Alendronate should not be given to pregnant women. Contraindication Hypocalcemia; Renal impairment; Vitamin D deficiency; Active gastrointestinal problem such as dysphagia, oesophago-duodenitis or ulcer; Pregnancy and breast feeding and Hypersensitivity to any components of the tablet. Overdosage No such information on overdosage with Alendronate.
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Side Effects The commonest symptomatic side effects are constipation, diarrhoea, esophageal ulcer, flatulence, dysphagia, musculoskeletal pain, headache, rarely rash, erythema, transient decrease in serum calcium and phosphate, nausea, vomiting, peptic ulceration, hypersensitivity reactions including urticaria and angioedema. Drug Interactions The incidence of upper gastrointestinal side effects are increased with the concomitant use of non-steroidal anti-inflammatory agents and aspirin. Absorption of Alendronate is reduced in the presence of antacids and calcium supplements. Commercial Pack Alendon 70 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains Alendronate Sodium BP equivalent to 70 mg of Alendronic Acid. Alendon 10 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains Alendronate Sodium BP equivalent to 10 mg of Alendronic Acid.
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Alphin ®DS Tablet
Description Alphin DS (Albendazole) is a broad spectrum anthelmintic available as chewable tablets, each containing 400 mg of Albendazole USP. It is a very potent benzimidazole carbamate anthelmintic used in the treatment of various intestinal worm infestations and hydatid disease. Indications Alphin DS (Albendazole) is indicated in - Ascariasis, Trichuriasis, Strongyloidiasis and Hookworm infestations - Enterobiasis, Capillariasis, Cysticercosis and Cutaneous larva migrans - Hydatid disease - Surgery as an adjunct therapy (either pre-or post-operatively) Dosage and Administration The usual dose for adults and children aged 2 years or over with ascariasis (roundworm), hookworm infestations, trichuriasis (whipworm) and cutaneous larva migrans is 400 mg as a single dose. In strongyloidiasis, 400 mg is given daily for 3 consecutive days. This may be repeated after 3 weeks if necessary. In enterobiasis (pinworm, threadworm), children aged 2 years or more have been given a single dose of 100 mg repeated after 7 days; the adult dose is 400 mg repeated after 7 days. In hydatid disease, the usual dose is 400 mg twice daily for adults. This is mostly given for 28-day cycles with a 2-week interval between cycles. The number of cycles ranges from 1 to 12, though 3 cycles may be sufficient for most cysts. Side Effects Gastrointestinal disturbances, headache and dizziness have been reported during treatment. These symptoms are usually mild and resolve without treatment. Rash, fever and rarely alopecia may occur during treatment. Contraindication Albendazole is absolutely contraindicated during pregnancy.
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Precautions Elevations in hepatic enzyme levels and reversible reduction in total white cell count have occasionally been reported. These changes appear to be more common during treatment of E. multilocularis. Drug Interactions Albendazole has been shown to induce liver enzymes of the cytochrome P450 system responsible for its own metabolism. There is, therefore, a theoretical risk of interaction with Theophylline, anticonvulsants, anticoagulants, oral contraceptives and oral hypoglycaemics. Care should therefore be exercised during the introduction of Albendazole in patients receiving the above groups of compounds. Overdosage There is no experience of overdosage. Gastric lavage may be performed in the first two to three hours after ingestion. No specific antidote is known. However, symptomatic treatment and general supportive measures should be undertaken as required. Commercial Pack Alphin DS Tablet : Box containing 50 chewable tablets in 5 x 10's aluminium strips, each chewable tablet contains Albendazole USP 400 mg.
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Amdocal® Tablet
Description Amdocal (Amlodipine) is a dihydropyridine calcium antagonist, with a long duration of action, used for the treatment of hypertension and angina pectoris. Indications Hypertension Amdocal is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Stable Agina Amdocal is indicated for the treatment of stable angina. Amdocal may be used alone or in combination with other antianginal agents. Vasospastic Angina Amdocal is indicated for the treatment of confirmed or suspected vasospastic angina. Amdocal may be used as single therapy or in combination with other antianginal drugs. Dosage and Administration The usual initial antihypertensive oral dose is 5 mg once daily with a maximum dose of 10 mg once daily. Elderly individuals or patients with hepatic insufficiency may be started on 2.5 mg once daily dose and this dose may be used when adding Amdocal to other antihypertensive therapy. Dosage should be adjusted according to each patient’s need The recommended dose for stable or vasospastic angina is 5-10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Contraindication Amlodipine is contraindicated in patients with known hypersensitivity to Amlodipine. 11
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Precautions General : Since the vasodilatation induced by Amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration of Amlodipine. Nonetheless, caution should be exercised when administering Amlodipine with any other peripheral vasodilator particularly in patients with severe aortic stenosis. Use in Patient with Congestive Heart Failure : Although haemodynamic studies and a controlled trial in Class-II-III heart failure patients have shown that Amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction and clinical symptomatology in general, all calcium channel blockers should be used with caution in patients with heart failure. β-blocker withdrawal : Amlodipine gives no protection against the danger of abrupt β-blocker withdrawal; any such withdrawal should be gradual reduction of the dose of β-blocker. Hepatic Failure : Since Amlodipine is extensively metabolized by the liver, so caution should be exercised when administering Amlodipine to patients with hepatic impairment. Drug interactions No significant drug interaction. Side Effects Peripheral oedema may occasionally be severe but is fully reversible. As with other calcium antagonist drugs, peripheral oedema and skin erythema occur in a proportion of patients (5-10%) and facial flushing in 2-5% of patients. Complaint of fatigue was also reported more frequently than in placebo-treated patients. There is evidence that these effects are more common in patients treated with doses greater than 10 mg daily. Overdosage In humans, experience with intentional overdosage of Amlodipine is limited. If massive overdosage occurs, active cardiac and respiratory
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monitoring should be instituted. Frequent blood pressure measurements are essential. Commercial Pack Amdocal-5 Tablet : Box containing 5 blister strips of 10 tablets, each tablet contains Amlodipine Besylate INN equivalent to Amlodipine 5 mg. Amdocal-10 Tablet : Box containing 3 blister strips of 10 tablets, each tablet contains Amlodipine Besylate INN equivalent to Amlodipine 10 mg.
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Anustat® Ointment
Description Pale yellow coloured homogenous ointment containing in each gram : Cinchocaine Hydrochloride BP 5 mg, Hydrocortisone BP 5 mg, Neomycin Sulphate USP equivalent to Neomycin 10 mg, Esculin Sesquihydrate Ger. P. equivalent to Esculin 10 mg. Action It provides an excellent combination of anti-inflammatory, anti-allergic and antipruritic action of corticosteroid, antibacterial action of locally effective antibiotic Neomycin, local anaesthetic action of Cinchocaine and skin protective action of Esculin. Indications Internal and external haemorrhoid, anal fissure, anal pruritus, perianal eczema, proctitis, pre-operative and post-operative treatment of haemorrhoidectomy, post-partum haemorrhoidal condition and as prophylaxis in between attacks. Dosage and Application A small quantity of the ointment should be applied with finger in the painful pruritic area in the morning and evening and after each stool. For deep application nozzle should be attached to the tube and inserted to full extent and should be squeezed gently from the lower end while withdrawing. Side Effects and Warning Side effects which have been reported for individual constituents may occur and appropriate precautions should be taken when using Anustat. Like most of the steroids under certain circumstances hydrocortisone may be absorbed in sufficient amount to produce systemic effects. So, long term use should be avoided. Adrenal suppression may occur even without occlusion. When used for prolonged period striae may occur.
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Skin sensitisation may occur due to Neomycin. Absorption of the antibiotic from wound or inflamed skin may occur and this may affect the hearing irreversibly. Hence Anustat should not be given to extensively damaged skin. Contraindication Sensitivity to any one of the constituents of Anustat. Pregnancy Topical steroid should not be used extensively in pregnancy. Commercial Pack Anustat Ointment : 15 g ointment in sealed aluminium tube with nozzle for application.
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Apresin ® Tablet
Description Fluphenazine Hydrochloride BP and Nortriptyline Hydrochloride BP combination has been found as an effective preparation for the patients suffering from "anxiety" or "depression" or both. Fluphenazine is a tranquilizer of the phenothiazine type. Nortriptyline is a tricyclic antidepressant having less sedative action. This combination helps to restore functional ability without developing any drug dependence. Dosage and Administration Adults : One Apresin tablet (Fluphenazine HCl 0.5 mg and Nortriptyline 10 mg as Nortriptyline HCl) 2 to 3 times daily. Indications - Mild to moderate mixed anxiety/depression - Emotional disturbance - Sleep disorder - Gastric problems Contraindication It is contraindicated in : - History of gradual epilepsy or organic brain damage - Blood dyscrasia - Severe cardiac insufficiency - Renal or liver damage - Patients taking monoamine oxidase inhibitor (MAOI) - Younger children - Hypersensitivity to any component of the preparation Adverse Effects Tardive dyskinesias have been reported in phenothiazine therapy; usually after prolonged courses given at doses adequately to control psychotic illness. Blood dyscrasia, malignant neuroleptic syndrome and sudden death have been reported rarely. Agranulocytosis is a rare but potentially fatal adverse effect of Nortriptyline Hydrochloride. 16
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Use in Pregnancy and Lactation The safety in human pregnancy has not been yet established. The use of this drug in lactation is not recommended, as it is excreted in breast-milk. Precautions Precautions should be taken in patients with glaucoma, prostate enlargement, cardiac failure and myocardial infarction, and in concurrent administration with CNS depressants. The drug may impair alertness and abilities to drive a car or operate machinery. Drug Interactions Interactions with barbiturates, alcohol, and narcotic drugs may occur, so central depressants should be administered with caution. Pharmaceutical Precautions Store in a cool place below 25o C. Keep out of the reach of children. Commercial Pack Apresin Tablet : Box containing 10 blister strips of 10 film coated tablets. Each tablet contains Fluphenazine Hydrochloride BP 0.5 mg and Nortriptyline 10 mg as Nortriptyline Hydrochloride BP.
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Arbit® Tablet
Description Arbit (Irbesartan) is an antihypertensive drug. It antagonizes angiotensin II receptor (AT1 subtype). Indications Arbit is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Dosage and Administration The recommended initial dose of Arbit is 150 mg once daily. Patients requiring further reduction in blood pressure should be treated to 300 mg once daily. Arbit may be administered with or without food. Contraindication Arbit is contraindicated in patients who are hypersensitive to any component of this product. Side Effects In placebo-controlled clinical trials the adverse event, which occurred in at least 1% of patients treated with Irbesartan and at a higher incidence versus placebo, included diarrhoea, dyspepsia, trauma, fatigue, and upper respiratory infection. Irbesartan use was not associated with an increased incidence of dry cough, as is typically associated with ACE inhibitor use. Rare side effects are urticaria, angioedema, jaundice, hyperkalaemia, and increased liver function tests. Use in Special Populations Paediatric : There is no data on safety and effectiveness of Irbesartan in children. Geriatric : In elderly subjects (age 65-80 years), no dosage adjustment is necessary. Renal Insufficiency : No dosage adjustment is necessary in patients with mild to severe renal impairment.
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Hepatic Insufficiency : No dosage adjustment is necessary in patients with hepatic insufficiency. Pregnancy and Nursing Mothers : When pregnancy is detected, Arbit should be discontinued as soon as possible. It is not known whether Irbesartan is excreted in human milk, so it should not be prescribed during lactation. Drug Interactions No significant drug interaction has been found in studies with Hydrochlorothiazide, Digoxin, Warfarin, and Nifedipine. Overdosage No data is available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well-tolerated. The most likely manifestations of overdosage are expected to be hypotension. Pharmaceutical Precautions Store at temperature between 15°C and 30°C. Commercial Pack Arbit 75 Tablet : Box containing 30 tablets in 3 x 10's blister strips. Each tablet contains Irbesartan INN 75 mg. Arbit 150 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains Irbesartan INN 150 mg.
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Aristocal® Tablet
Description Aristocal contains Calcium Carbonate that is used as dietary calcium supplement, and to sequester phosphorus in the intestine to reduce total body phosphate accumulation in chronic renal failure. Each Aristocal tablet contains 1250 mg Calcium Carbonate BP equivalent to 500 mg elemental Calcium. Indications ♦ For dietary calcium supplement when it is deficient ♦ As a phosphate binder in chronic renal failure ♦ As an adjunct therapy in the arrest or slowing down of bone demineralization in osteoporosis. Dosage and Administration Adults and Elderly : Dietary deficiency- 2 to 3 tablets daily. As Phosphate binder- Dose as required by the individual patient depending on serum calcium and phosphate levels. Adjunct to osteoporosis therapy- 2 to 3 tablets daily. Contraindication ♦ Hypercalcaemia and hyperparathyroidism ♦ Renal calculi and nephrolithiasis ♦ Zollinger-Ellision syndrome and other causes of gastric acid hypersecretion. Adverse Effects Mild gastrointestinal disturbances (e.g. flatulence, abdominal pain, constipation) may occur. Hypercalcaemia and alkalosis are rarely produced with large doses. Precautions In mild hypercalciuria or renal failure or stone formation in urinary tract, adequate checks must be kept on urinary calcium excretion. If necessary the dosage should be reduced or calcium therapy discontinued. 20
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Use in Pregnancy and Lactation Calcium containing drugs are used widely in pregnancy by way of oral calcium supplementation. Calcium Carbonate can be used in lactating women too. Drug Interactions Calcium Carbonate may enhance the cardiac effects of Digoxin and other cardiac glycosides if systemic hypercalcaemia occurs. It may interfere with the absorption of concomitantly administered Tetracycline preparations. Modification of vitamin D therapy may be required to avoid hypercalcaemia when Calcium Carbonate is used as a phosphate binder in chronic renal failure. Concurrent administration of Calcium Carbonate reduces total absorption and peak serum levels of Ciprofloxacin. Pharmaceutical Precautions Store in a cool and dry place. Keep out of the reach of children. Commercial Pack Aristocal Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Each tablet contains Calcium Carbonate BP equivalent to 500 mg elemental Calcium.
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Aristoferon ® Syrup
Description Aristoferon is a haematinic preparation of Ferrous Sulphate available as raspberry flavored syrup. Each 5 ml of syrup contains 200 mg of Ferrous Sulphate BP. Ferrous Sulphate has the general properties of iron salts and is one of the most widely used iron salts in the treatment of iron deficiency anaemia. Indications Aristoferon is indicated in the treatment and prevention of iron deficiency anaemia and anaemia of pregnancy where routine administration of iron is necessary. Dosage and Administration Adult Initial therapeutic dose : 3-4½ teaspoonful daily in divided doses or as prescribed by the physician. Maintenance dose : 1½ teaspoonful daily, but if needed up to 1.8 g (9 teaspoonful) daily can be given. Children ♦Under 1 year : ¼ th teaspoonful thrice daily or as directed by physician ♦1-5 years : 1 teaspoonful thrice daily ♦6-12 years : 1½ teaspoonful twice daily Note : i) Mix with water or fruit juice to avoid temporary staining of teeth. ii) Do not mix with milk. Contraindication ♦ Iron therapy is contraindicated in haemachromatosis and haemosiderosis. ♦ It should not be given to patients receiving repeated blood transfusion or with anaemia not produced by iron deficiency. 22
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Precautions Should be administered with caution when given to patients with iron storage or iron absorption disease, haemoglobinopathies or existing gastrointestinal disease. Absorption of iron salt and Tetracycline is diminished when taken concomitantly by mouth. If treatment with both drugs is required iron salt should be given 3 hours before or 2 hours after Tetracycline. Absorption of iron is also decreased in the presence of Antacids or when taken with tea. Side Effects Therapeutic doses of iron may cause gastrointestinal symptoms like diarrhoea, nausea and vomiting. Although iron is better absorbed between meals, side effects can be reduced by taking it with or immediately after food. Continuous administration may sometimes cause constipation. Iron containing liquid medication may cause temporary staining of teeth (this is less likely when diluted). Commercial Pack Aristoferon Syrup : Aristoferon 200 ml syrup in glass bottle, each 5 ml containing 200 mg of Ferrous Sulphate BP.
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Aristofol-Fe ® Tablet
Description Each sugar coated Aristofol-Fe tablet contains 308 mg of Ferrous Fumarate BP (eqv. to 100 mg of elemental iron) and 350 µg of Folic Acid USP. Iron and Folic Acid are required for normal haemopoiesis. Indications Prophylaxis and treatment of iron deficiency anaemia in pregnancy. Prevention of megaloblastic anaemia of pregnancy. Dosage and Administration ♦ In anaemia usual dose is one tablet daily. ♦
In severe or refractory iron deficiency anaemia, one tablet twice daily may be given.
♦
In Pregnancy, it is recommended that Aristofol-Fe should be started at the first antenatal consultation and continued until 3 months after delivery.
Contraindication Aristofol-Fe is contraindicated in megaloblastic anaemia due to vitamin B 12 deficiency. Precautions Administration of Aristofol-Fe during the first trimester of pregnancy may be undesirable. Very few pregnant women are not protected by physiological doses of folic acid. If anaemia is developed despite prophylaxis with Aristofol-Fe, patients should be investigated further. Some postgastrectomy patients show poor absorption of iron. Care is needed when treating patients with peptic ulcer. When Aristofol-Fe and Tetracycline are taken concomitantly, absorption of both drugs are reduced. Concurrent administration of antacid may reduce absorption of iron. Serum anticonvulsant levels may be reduced by administration of folate. 24
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Side Effects Gastrointestinal disorders and allergic reactions have been reported. Treatment of Overdosage Ingestion of an overdose of iron orally requires emergency treatment along the following lines. Vomiting should be induced immediately, followed (as soon as possible) by parenteral injection of Desferrioxamine Mesylate and then gastric lavage. In the mean time it is helpful to give milk and or 5% sodium bi-carbonate solution by mouth. Intramuscular desferrioxamine injection may be given. A desferrioxamine solution (5 g in 50-100 ml) may be left in the stomach. If Desferrioxamine is not available, 300 ml of 1% to 5% sodium bi-carbonate solution should be left in the stomach. Fluid replacement is essential. Commercial Pack Aristofol-Fe Tablet : Box containing 100 tablets in 10 x 10’s blister strips. Each sugar coated Aristofol-Fe tablet contains 308 mg of Ferrous fumarate (eqv. to 100 mg of elemental iron) and 350 µg of Folic Acid.
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Aristoplex® Syrup
Description Aristoplex is a liquid preparation of Vitamin B-Complex. Each 5 ml Aristoplex syrup contains: Thiamine Hydrochloride (Vitamin B1) Riboflavin (Vitamin B2 ) Pyridoxine Hydrochloride (Vitamin B6) Nicotinamide
BP
5 mg
USP BP
2 mg 2 mg
BP
20 mg
Indications ♦ Prevention and treatment of Vitamin B-Complex deficiency states, manifested by glossitis, stomatitis, cheilosis, beriberi and polyneuritis. ♦
Maintenance of normal growth and health during the early days of children.
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Apathy and anorexia in elderly patients.
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Prevention of vitamin deficiencies, particularly when depletion is suspected; - Pregnancy and lactation - Convalescence during debilitating illness - Patients on restricted diets
Dosage and Administration Adults and Elderly : One to two 5 ml spoonful syrup three times a day. Children : One 5 ml spoonful syrup three times a day. Infants : One 5 ml spoonful syrup daily.
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Contraindication Known hypersensitivity to any of the active constituents. Precautions Pyridoxine may reduce the therapeutic efficacy of Levodopa. Use in Pregnancy and Lactation As with all medicines, careful considerations should be given before the administration of B-Complex preparations during the first trimester of pregnancy. Vitamins are excreted in breast milk. Pharmaceutical Precautions Store in a cool place. The syrup should be protected from light. Commercial Pack Aristoplex Syrup : Aristoplex syrup is available in 100 ml and 200 ml amber glass bottle. Each 5 ml Aristoplex syrup contains multivitamin.
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Aristovit®-B Tablet
Description Aristovit-B is a sugar coated tablet containing different B-Vitamins. Each tablet contains 20 mg of Nicotinamide USP, 2 mg of Pyridoxine Hydrochloride USP, 2 mg of Riboflavin USP and 5 mg of Thiamine Mononitrate USP. Indications Aristovit-B is indicated in the treatment and prevention of Vitamin B deficiencies, particularly when depletion is suspected, such as in case of pregnancy and lactation, convalescence following debilitating illness and in restricted diet. Dosage and Administration One or two tablets three times daily. Contraindication Contraindicated in case of hypersensitivity to any of the active ingredients of Aristovit-B. Precaution Should be given cautiously to patients taking Levodopa as Pyridoxine reduces the effect of Levodopa. Commercial Pack Aristovit-B Tablet : Bottle containing 45 sugar coated tablets. Each sugar coated tablet contains different B-Vitamin.
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Aristovit®-M Tablet
Description Aristovit-M is sugar-coated multivitamin-mineral tablet. Each tablet contains : Vitamin A Vitamin D Thiamine Mononitrate (B1) Riboflavin Ascorbic Acid Nicotinamide Pyridoxine HCl (B6) Folic Acid Calcium Pantothenate Cyanocobalamin (B12) Vitamin E Ferrous Sulphate Potassium Iodide Potassium Sulphate Manganese Sulphate Monohydrate Cupric Sulphate Pentahydrate Zinc Sulphate
USP USP USP USP USP USP USP USP USP USP USP USP USP BP USP USP USP
1.5 mg 10 µg 1.5 mg 1.7 mg 60 mg 20 mg 2 mg 0.4 mg 10.92 mg 6 µg 10.05mg 50 mg 196 µg 11.14 mg 1 mg 2 mg 37.04 mg
Indications Deficiency states in acute and chronic disease. Conditions regarding specific support : pregnancy, lactation, menopause, during treatment with antibiotics. The comprehensive formulae of Aristovit-M assures liberal amounts of important vitamins, minerals and trace elements needed by the body during periods of increased energy requirements such as in disease and convalescence. Dosage and Administration One tablet daily or as advised by the physician.
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Contraindication Supplemental vitamins and minerals should not be prescribed for patients with haemochromatosis or Wilson’s disease. Hypersensitivity to any of the active ingredients is a contraindication. Excessive doses of vitamin A and D can lead to hypervitaminosis. When multivitamin preparations are prescribed allowance must be made for vitamins from other sources. This is particularly important during the first trimester of pregnancy when large doses of Vitamin A may be teratogenic. Iron and Zinc chelate with Tetracyclines and absorption of all three agents may be impaired. Side Effects Multivitamin preparation with ordinary doses of component are usually nontoxic. Precautions Aristovit-M may be used in patients being treated for Parkinson’s disease with a Levodopa preparation which includes a dopa-decarboxylase inhibitor (e.g. Carbidopa, Benserazide). But precautions should be taken Pyridoxine acts as an antagonist of Levodopa. Pharmaceutical Precautions Store in a cool and dry place at a temperature not exceeding 25°C and protect from light. Commercial Pack Aristovit-M Tablet : Bottle containing 30 sugar coated tablets. Each sugar coated tablet contains multivitamin and mineral.
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Aristovit®-X Tablet
Description Aristovit-X is a special formulation comprising of important vitamin, anti-oxidants and minerals. Each tablet contains: Vitamin A Vitamin E Vitamin K Vitamin C Zinc Copper Manganese Selenium
2000 IU 50 IU 75.00 µg 200.00 mg 15.00 mg 1.00 mg 3.00 mg 70.00 µg
Indications Aristovit-X is a once-daily tablet indicated for use to develop immune system, help prevent the well-known deficiency diseases such as scurvy, beriberi, pellagra and others, prevent certain types of cancer by blocking the formation of cancer causing substances in the body. It is also capable of combating cardiovascular and immunological disorders. Aristovit-X helps strengthen immune system, keeping free from sickness and allowing a better, harder workout. Dosage and Administration Aristovit-X may be administered once daily or as indicated by the physician. Contraindication Aristovit-X is contraindicated in patients with a known hypersensitivity to any of the ingredients. Side Effects Generally well tolerated.
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Precautions Excess vitamin A intake may be toxic and may increase the risk of birth defects. Pregnant women and women who may become pregnant should not exceed total 5000 IU of vitamin A (retinyl palmitate) per day. Drug Interactions No drug interactions have been reported. Use in Pregnancy and Lactation Aristovit-X is recommended in pregnancy and lactation Pharmaceutical Precautions Tablets should be stored below 25 οC and protected from light and moisture. Commercial Pack Aristovit-X Tablet : Plastic bottle containing 30 film coated tablets. Each tablet contains multivitamin, antioxidants and minerals.
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Arixon® Injection
Description Arixon (Ceftriaxone) is highly stable to most β-lactamase, both penicillinases and cephalosporinases of Gram-positive and Gramnegative bacteria. The action of Arixon is bactericidal which inhibits the cell wall synthesis. It is most effective against the following microorganisms: Gram-positive bacteria: Staphylococcus aureus (including penicillinase producing strains), Staphylococcus epidermis, Streptococcus, Streptococcus pneumoniae, Streptococcus bovis. Gram-negative bacteria: Escherichia coli, Haemophilus influenzae (including penicillinase-producing strains), Neisseria gonorrhoeae, Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris. Indications It is indicated for the treatment of sepsis; meningitis; abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts), infections of the bones, joints, soft tissue, skin and/or wounds infections in patients with impaired defense mechanism; renal and urinary tract infections; respiratory tract infections, particularly pneumonia, and ear, nose and throat infections, and genital infections including gonorrhoea. Dosage and Administration Adults and children over twelve years : The usual dosage is 1 to 2 g of Arixon administered once daily in 24 hours. In severe cases infections caused by moderately sensitive organisms, the dose may be increased to 4 g once daily. Neonates, infants and children up to 12 years : For Neonates (up to 2 weeks) a daily dose of 20-50 mg/kg body weight, not to exceed 50 mg/kg on account of the immaturity of the infants is advised. For children with body weight of 50 kg or more, the usual adult dose should be used.
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Elderly patients : The dosage recommended for adults require no modification in case of geriatric patients. Duration of Therapy The duration of therapy varies according to the course of the diseases. As with antibiotic therapy in general administration, Arixon should be continued for a minimum of 48-72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained. For the treatment of gonorrhoea, a single intramuscular dose of 250 mg Arixon is recommended. Precautions As with other cephalosporins anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate counter measures. Side Effects Diarrhoea, nausea, vomiting, stomatitis and glossitis. Pharmaceutical Precautions Arixon should be stored at below 30o C. Commercial Pack Arixon 250 mg IM Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 250 mg and one ampoule of 2 ml Lignocaine Injection BP 1%. Arixon 500 mg IM Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg and one ampoule of 2 ml Lignocaine Injection BP 1%. Arixon 1 g IM Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 1 g and one ampoule of 3.5 ml Lignocaine Injection BP 1%. Arixon 250 mg IV Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 250 mg and one ampoule of 5 ml Water for Injection BP.
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Arixon 500 mg IV Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg and one ampoule of 5 ml Water for Injection BP. Arixon 1 g IV Injection : Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 1 g and one ampoule of 10 ml Water for Injection BP.
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Arlin® Tablet/Suspension
Description Arlin contain Linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. Arlin film coated tablets for oral administration contain 400 mg or 600 mg Linezolid. Arlin oral suspension is supplied as powder for reconstitution into a suspension for oral administration. Indications Vancomycin-Resistant Enterococcus faecium infections, including cases with concurrent bacteremia. Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), or Streptococcus pneumoniae (penicillin-susceptible strains). Combination therapy may be clinically indicated if the documented or presumptive pathogens include Gram-negative organisms. Complicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae. Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillinsusceptible only) or Streptococcus pyogenes. Community-acquired pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible strains only), including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible strains only). Dosage and Administration i) Vancomycin- resistant Enterococcus faecium infections, including concurrent bacteremia, recommended dose is 600 mg 12 hourly for 14 to 28 days. ii) Nosocomial pneumonia, Complicated skin and skin structure infections, and Community-acquired pneumonia, including concurrent bacteremia, recommended dose is 600 mg 12 hourly for 10 to 14 days. iii) Uncomplicated skin and skin structure infections recommended dose is 400 mg 2 hourly for 10 to 14 days.
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Contraindication Arlin formulations are contraindicated for use in patients who have known hypersensitivity to Linezolid or any of the other product components. Side Effects Most of the adverse events reported with Arlin are mild to moderate in intensity. The most common adverse events in patients treated with Arlin were diarrhoea, headache and nausea. Other adverse events included oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus, and tongue discolouration. Use in Pregnancy and Lactation There are no adequate and well-controlled studies in pregnant women. Arlin should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. It is not known whether Linezolid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Arlin is administered to a lactating woman. Drug Interactions Monoamine Oxidase Inhibitors: Linezolid is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, Linezolid has the potential for interaction with adrenergic and serotonergic agents. Adrenergic Agents : Some individuals receiving Arlin may experience a reversible enhancement of the pressor response to sympathomimetic agents, vasopressor or dopaminergic agents. Commonly used drugs such as Phenylpropanolamine and Pseudoephedrine have been specifically studied. Initial doses of adrenergic agents, such as Dopamine or Epinephrine, should be reduced and titrated to achieve the desired response. Serotonergic Agents : Co-administration of Linezolid and serotonergic agents was not associated with serotonin syndrome in studies. Since there is limited experience with concomitant administration of Linezolid and serotonergic agents, physicians should be alert to the possibility of signs and symptoms of serotonin syndrome (e.g. hyperpyrexia and cognitive dysfunction) in patients receiving such concomitant therapy. 37
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Overdosage In the event of overdosage, supportive care is advised with maintenance of glomerular filtration. Haemodialysis may facilitate more rapid elimination of Linezolid. Pharmaceutical Precautions Store at temperature between 15o C and 30o C. Commercial Pack Arlin 400 Tablet : Box containing 20 tablets in 2 x 10's blister strips. Each film coated tablet contains Linezolid INN 400 mg. Arlin 600 Tablet : Box containing 20 tablets in 2 x 10's blister strips. Each film coated tablet contains Linezolid INN 600 mg. Arlin Powder for Suspension : Dry Powder in amber glass bottle for reconstitution into 100 ml Suspension. After reconstitution each 5 ml contains Linezolid INN 100 mg.
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Ascobex ® Tablet
Description Ascobex tablet contains Ascorbic Acid USP 100 mg, Sodium Ascorbate USP 168.75 mg, the combination is equivalent to 250 mg of Ascorbic Acid (Vitamin C). Ascorbic Acid (Vitamin C) is essential for synthesis of collagen and intracellular materials. It is involved in important metabolic reactions. Deficiency may arise due to decrease in absorption or increase in requirement due to certain physiological conditions such as pregnancy, lactation, post-operative state, growing age etc. Ascobex can be used to treat vitamin C deficiency and in those conditions where there is an increased requirement of vitamin C. Ascobex is also used as an antioxidant vitamin. Indications Vitamin C deficiency disorders, pregnancy, lactation, post-operative or other wound healing state, infection, growing age, thyrotoxicosis, and common cold. Being an antioxidant vitamin, it protects against cardiovascular diseases, atherosclerosis, malignancy and it has been found to delay the aging process. It has been found that in case of diabetes, there is an increase in requirement of vitamin C, Ascobex is also indicated in that condition. Dosage ♦ In scurvy ♦ In wound healing ♦ In other conditions
: : :
4 tablets 2 to 3 times daily 2-4 tablets 2 to 3 times daily 1-2 tablets daily
Precautions Should be given with caution to patient with hyperoxaluria. Tolerance may be induced in patients taking higher doses.
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Side Effects Ascorbic acid does not seem to have any important adverse effects at dosages less than 4 mg/day. Larger dose may cause diarrhea or formation of renal calculi of calcium oxalate in patients with renal impairment. Ingestion of more than 600 mg daily have a diuretic action. Commercial Pack Ascobex Tablet : Box containing 200 tablets in 10 X 20’s blister strips, each tablet contains Ascorbic Acid USP 100 mg, Sodium ascorbate USP 168.75 mg, the combination is equivalent to 250 mg of Ascorbic Acid (Vitamin C).
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Atova ® Tablet
Description Atova (Atorvastatin Calcium) is a synthetic lipid-lowering agent. It is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA). This enzyme catalyzes the conversion of HMG-CoA to mevatonate, an early and rate limiting step in the synthesis of cholesterol. Indications Atova is indicated as an adjunct to diet to reduce elevated total cholesterol, low density lipoprotein-cholesterol (LDL-C), apolipoprotein B and triglyceride (TG) levels in patients with primary hypercholesterolaemia (heterozygous familial and non familial) and mixed dyslipidaemia (Fredrickson Types lla and llb). Atova is indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV). Atova is indicated for the treatment of patients with primary dysbetalipoproteinaemia (Fredrickson Type III) who do not respond adequately to diet. Atova is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Therapy with lipid altering agent should be a component of multiple risk factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolaemia. Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures have been inadequate (see Table 1). At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C level is >130 mg/dl [National Cholesterol Education Program (NCEP) Adult Treatment Panel II (ATP II)]. 41
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Prior to initiating therapy with Atova, secondary causes for hypercholesterolaemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be excluded, and a lipid profile performed to measure total-C, LDL-C, HDL-C, and TG. For patients with TG4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V). TABLE 1 - NCEP GUIDELINES FOR LIPID MANAGEMENT Definite Atherosclerotic Diseasea
Two or More Other Risk Factorsb
LDL-Cholesterol mg/dl (mmol/L)
Initiation Level
Minimum Goal
No
No
>190 (>4.9)
4.1)
3.4)
55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C < 35 mg/dl (< 0.91 mmol/L); and diabetes mellitus. Subtract 1 risk factor if HDL-C is > 60 mg/dl (>1.6 mmol/L). c. In CHD patients with LDL-C levels 100 to 129 mg/dl, the physician should exercise clinical judgement in deciding whether to initiate drug treatment.
Dosage and Administration Adults : The patient should be placed on a standard cholesterol-lowering diet before receiving Atova and should continue on this diet during treatment with Atova.
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Hypercholesterolaemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidaemia (Fredrickson Types IIa and IIb) : The recommended starting dose of Atova is 10 mg daily. The dosage range is 10 to 80 mg once daily. Atova can be administered as a single dose at any time of the day with or without food. Therapy should be individualized according to goal of therapy and response. After initiation and/or upon titration of Atova, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. Since the goal of treatment is to lower LDL-C, the LDL-C levels should be used to initiate and assess treatment response. Only if LDL-C levels are not available, total-C should be used to monitor therapy. Homozygous Familial Hypercholesterolaemia : The dosage of Atova in patients with homozygous Familial Hypercholesterolaemia is 10 to 80 mg daily. Atova should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavoidable. Patients with renal insufficiency: Renal disease has no influence on the plasma concentrations or lipid effects of Atorvastatin; thus no adjustment of dose is required. Haemodialysis is not expected to significantly enhance the clearance of Atorvastatin since the drug is extensively bound to plasma proteins. Patients with hepatic dysfunction: In patients with moderate to severe hepatic dysfunction, the therapeutic response to Atorvastatin is unaffected but exposure to the drug is greatly increased. C max increases by approximately 16 fold and AUC (0-24) by approximately 11 fold. Therefore, caution should be exercised in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Contraindication Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal. Use in Pregnancy and Lactation Safety in pregnancy has not been established. Rare reports of congenital
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anomalies have been reported following intrauterine exposure to HMGCoA reductase inhibitors. HMG-CoA reductase inhibitors are not recommended for use during pregnancy. An interval of 1 month should be allowed from stopping Atorvastatin treatment to conception in the event of planning a pregnancy. Use of HMG-CoA reductase inhibitors during breast feeding is not recommended, because of the potential for serious adverse effects in nursing infants. Use in Special Population Children : Safety and efficacy of Atorvastatin have not been established in children. Geriatrics : Efficacy and safety in older patients using recommended doses is similar to that seen in the general population. Carcinogenicity/mutagenicity Atorvastatin was not found to be carcinogenic in rats; the maximum dose used was 63 fold higher than the highest human dose (80 mg/day) on a mg/kg body weight basis. Precautions Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in this class. Atorvastatin may cause an elevation in serum creatinephosphokinase (CPK) levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with Atorvastatin. Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. The risk of myopathy during treatment with other drugs in this class is increased with concurrent administration of Cyclosporin, fibric acid derivatives, Erythromycin, Niacin, or azole anti-fungals. Patients should be advised to report promptly any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. 44
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Side Effects Atorvastatin is generally well tolerated. Adverse effects reported commonly include constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, diarrhoea, asthenia and insomnia. Dose related and reversible elevated serum alanine transaminase (ALT) levels have been reported in approximately 1.3% of patients receiving Atorvastatin. Elevated serum CPK levels have been reported in some patients on Atorvastatin but only in rare cases patients may have muscle pain, tenderness or weakness. Other side effects reported in clinical trials (not all effects have necessarily been associated with Atorvastatin therapy) include muscle cramps, myopathy, paresthesia, peripheral neuropathy, pancreatitis, hepatitis, cholestatic jaundice, anorexia, vomiting, pruritus, rash, impotence, hyperglycaemia and hypoglycaemia. Chest pain, dizziness, angina and allergic reactions have been reported in isolated cases. Overdosage There is no specific treatment available for Atorvastatin overdosage. General supportive measures should be adopted as required. Liver function tests and serum CPK levels should be monitored. Due to extensive drug binding to plasma proteins, haemodialysis is not expected to significantly enhance Atorvastatin clearance. Pharmaceutical Precautions Storage below 20o C, protected from moisture. Commercial Pack Atova 10 Tablet : Box containing 10 tablets in 1 x 10’s blister strip, each tablet contains Atorvastatin Calcium INN equivalent to Atorvastatin 10 mg. Atova 20 Tablet : Box containing 10 tablets in 1 x 10’s blister strip, each tablet contains Atorvastatin Calcium INN equivalent to Atorvastatin 20 mg.
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Atrizin® Tablet/Syrup
Description Atrizin is available in both tablet and syrup form. Each film coated tablet contains Cetirizine Hydrochloride BP 10 mg and each 5 ml cherry flavoured syrup contains 5 mg of Cetirizine Hydrochloride BP. Cetirizine is a piperazine derivative and a potent functional antagonist of histamine H 1 receptors. Atrizin is a long acting antihistamine. Central sedation or antimuscarinic effects do not generally occur with the usual doses of Atrizin. Indications Atrizin is indicated for the prevention and symptomatic relief of allergic manifestations, such as: - Seasonal allergic rhinitis - Perennial allergic rhinitis - Chronic idiopathic urticaria Dosage and Administration Atrizin tablet : Adults and children over 12 years- 10 mg (1 tablet) once daily. Atrizin syrup: Adult and Children over 6 years- 10 mg (2 teaspoonful) daily. Child 2-6 years- 5 mg (1 teaspoonful) daily or 2.5 mg (½ teaspoonful) twice daily. The maximum recommended dose is 20 mg (2 tablets or 4 teaspoonful) daily. Cetirizine is safe for use in the elderly patients. Less frequent dosing is advised in patients with reduced creatinine clearance. Contraindication Cetirizine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to it or its parent compound- Hydroxyzine. Adverse Reaction No potentially life threatening effects have been encountered. 46
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Acute Overdosage In the occasional cases patient taking a massive intentional overdose (150300 mg), sedation has been the only adverse effect and complete recovery has ensured. Like other H1 receptor antagonists, Cetirizine has no specific antidote. Precautions Neonates : The drug is not usually administered to neonates. Children : Cetirizine is effective and well tolerated in children. No special precautions are required in children over 6 years of age. Use in Pregnancy and Lactation Cetirizine is not teratogenic in animals. Since the animal studies are not always predictive of human response, it should be used only if the potential benefit justifies the potential risk to the foetus. The extent of Cetirizine excretion in human breast milk is unknown but some animal studies have shown excretion in breast milk. Nursing mothers are advised not to take this medication. Drug Interaction There are no reports of hazardous interactions with other drugs to date. Concomitant administration with alcohol or Diazepam does not impair psychomotor performance any more than the impairment of performance produced by alcohol alone. Commercial Pack Atrizin Tablet : Box containing 10 blister strips of 10 film coated tablets, each tablet contains Cetirizine Hydrochloride BP 10 mg. Atrizin Syrup : Amber glass bottle containing 60 ml syrup. Each 5 ml syrup contains Cetirizine Hydrochloride BP 5 mg .
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Avastin ® Tablet
Description Avastin is a preparation of Simvastatin which acts as a cholesterol lowering agent. Avastin inhibits 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, an enzyme which catalyses the biosynthesis of cholesterol. Mode of Action The main mechanism of reduction of low density lipoprotein (LDL) cholesterol is that, following inhibition of HMG-CoA reductase activity, the LDL receptor density on the liver cells is increased and this leads to an increased removal of LDL cholesterol from the plasma and increased catabolism of LDL cholesterol. In addition, there is a reduction in very low-density lipoprotein (VLDL) cholesterol and reduced formation of LDL from VLDL. Indications Avastin is indicated in patients with primary hypercholesterolaemia who have not responded adequately to diet and other appropriate measures. To reduce incidence of clinical coronary events and slow progression of coronary atherosclerosis in patients with coronary heart disease and cholesterol concentration of 5.5 mmol/litre or greater. Dosage and Administration The patients should be placed on a standard cholesterol-lowering diet before receiving Avastin and maintained on it during treatment. Doses should be individualized according to baseline LDL-cholesterol levels, the recommended goal of therapy and the patient’s response. Adjustment of dosage should be at intervals of 4 weeks or more. In hypercholesterolaemia, the recommended starting dose is 5-10 mg once a day in the evening. The recommended dose range is 5-40 mg per day as a single dose in the evening.
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The patients with coronary heart disease and hypercholesterolaemia, the starting dose should be 20 mg once a day in the evening. Safety and effectiveness in children and adolescents have not been established. Contraindication Hypersensitivity to any component of the preparation; Active liver disease; Pregnancy and lactation; women of child-bearing potential unless adequately protected by contraception; in patients with the homozygous form of familial hypercholesterolaemia, in whom there is a complete absence of LDL receptors. As Simvastatin has only a moderate triglyceride-lowering effect, it is not indicated where hypertriglyceridaemia is the abnormality of most concern. Side Effects Avastin is generally well tolerated, no potentially life-threatening effects have been reported. Headache, fatigue, insomnia, gastrointestinal effects like nausea, constipation or diarrhoea, flatulence, dyspepsia, abdominal cramps, and muscular effects like myalgia, myositis and myopathy have been reported. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been associated with Simvastatin therapy. Hepatitis, pancreatitis, rash, angioedema have also been reported. Drug Interactions Digoxin : Concomitant administration of Simvastatin and Digoxin in normal volunteers resulted in a slight elevation (less than 0.3 ng/ml) in drug concentrations in plasma compared to concomitant administration of placebo and Digoxin. Coumarin derivatives : The administration of Simvastatin appeared to enhance slightly the anticoagulant effect of Warfarin (mean changes in prothrombin time less than two seconds) in normal volunteers maintained in a state of low therapeutic anticoagulation. Others : In clinical studies, Simvastatin was used concomitantly with angiotensin-converting enzyme (ACE) inhibitors, β-blockers, calcium channel blockers, diuretics and non-steroidal 49
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anti-inflammatory drugs (NSAIDs) without evidence of clinically significant adverse interactions. Precautions Monitor liver function before and during treatment; History of liver disease (avoid if active); High alcohol intake; Avoid pregnancy during and for 1 month after treatment; Advise patients to report if there is any muscle pain. Simvastatin should be discontinued if markedly elevated CPK levels occur or if myopathy is diagnosed. Overdosage There are no data available on overdose. No antidote is available. General measures should be adopted and liver function should be monitored. Commercial Pack Avastin Tablet : Box containing 30 film coated tablets in 3 x 10’s blister strips, each tablet contains Simvastatin USP 10 mg.
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Avidro® Tablet
Description Avidro is the brand name of Pizotifen, which is a tricyclic compound having antiserotoninergic and antihistaminic effects together with a weak anticholinergic action. Pizotifen inhibit the permeability-increasing effects of serotonin and histamine on the affected cranial vessels, thereby checking the transudation of plasmakinin so that pain threshold of the receptors is maintained at normal levels. In the sequence of events leading to the migraine attack, depletion of plasma serotonin contributes to loss of tone in the extra-cranial vessels. Pizotifen inhibits serotonin reuptake by the platelets, thus maintaining plasma serotonin and preventing the loss of tone and passive distension of the extra-cranial arteries. Indications It is used as prophylactic treatment of vascular headaches of the migraine types, such as classic migraine, common migraine and cluster headache. Dosage and Administration Adult : Usually 1.5 mg daily, which may be taken as a single dose at night or in three divided doses. Dose should be adjusted to individual patient's requirements. Up to a maximum of 4.5 mg daily and up to 3 mg may be given as a single dose daily. Children : Up to 1.5 mg daily, usually in divided dose, and daily 1 mg as a single dose has been given at night using 0.5 mg tablet. Duration of treatment : 3-6 months; minimum one month to observe the benefit. Contraindication Although its anticholinergic activity is relatively weak, Pizotifen should probably not be administered in presence of narrow angle glaucoma or prostate hypertrophy. It should not be given in patients with hypersensitivity to this drug.
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Use in Pregnancy and Lactation Information of using Pizotifen in pregnancy is limited, so it should only be used during pregnancy under compelling circumstances and it is not recommended to the nursing mother. Side Effects Drowsiness is the most common side effect and also increased appetite, which may lead to increase in body weight. Other side effects are, dizziness, dry mouth, nausea, constipation, which are rare. In children central nervous system (CNS) stimulation may occur. Precautions Patients should be cautioned about the possibility of drowsiness and informed of its significance in driving vehicles and operation of machineries. Pizotifen may enhance the central effects of sedatives, hypnotic, antihistamines and alcohol. Dose adjustment may be required in patients with renal insufficiency. Commercial Pack Avidro 0.5 Tablet : Box containing 10 x 10's tablets in blister strips. Each film coated tablet contains Pizotifen Malate BP equivalent to Pizotifen 0.5 mg. Avidro 1.5 Tablet : Box containing 5 x 10's tablets in blister strips. Each film coated tablet contains Pizotifen Malate BP equivalent to Pizotifen 1.5 mg.
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Avifanz ® Tablet
Description Avifanz is the brand name for Efavirenz. Efavirenz, a synthetic antiretroviral agent, is a non-nucleoside reverse transcriptase inhibitor. While Efavirenz is pharmacologically related to other non-nucleoside reverse transcriptase inhibitors, Efavirenz differs structurally from these drugs and also differs structurally from other currently available anti-retroviral agents. Indications Avifanz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection. This indication is based on analysis of plasma HIV-RNA levels and CD4 cell counts in controlled studies of up to 24 weeks in duration. At present, there are no results from controlled trials evaluating long-term suppression of HIV- RNA with Avifanz. Dosage and Administration Adults : The recommended dosage of Avifanz is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs). Avifanz may be taken with or without food; however, a high fat meal may increase the absorption of Avifanz and should be avoided. In order to improve the tolerability of nervous system side effects, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms. Avifanz must be given in combination with other antiretroviral medications. Paediatric Patients : The following table describes the recommended dose of Avifanz for paediatric patients 3 years of age or older and weighing between 10 to 40 kg. The recommended dosage of Avifanz for paediatric patients weighing greater than 40 kg is 600 mg, once daily.
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Body Weight Kilogram 10 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40 40<
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22 to < 33 33 to < 44 44 to < 55 55 to < 71.5 71.5 to < 88 88<
200 250 300 350 400 600
Paediatric Dose to be Administered Once Daily Contraindication Efavirenz is contraindicated in patients with known hypersensitivity to the drug or any ingredient in formulation. Warning and Precautions The drug should not be used in pregnant women or who plan to become pregnant, and also in lactating women. High fat foods may cause unwanted increases in drug effect, so avoid taking this drug with high-fat foods. Regular, periodic measurement plasma HIV-1 RNA levels and CD4+ Tcell counts is necessary to determine the risk of disease progression and to determine when to modify anti-retroviral agent regimens. Patients should be advised that Efavirenz has not been shown to reduce the risk of transmission of HIV to others via sexual contact or blood contamination and so the practices designed to prevent transmission of HIV should be maintained during anti-retroviral therapy. Efavirenz should always be administered in conjunction with other anti-retroviral agent and should not be used alone in the treatment of HIV infection. Although Efavirenz used in combination with other anti-retroviral agents appears to be well tolerated, patients should be monitored closely for adverse effects during combination therapy. The usual precautions and contraindication of the other anti-retrovirals in the regimen should be considered during combination therapy; Efavirenz should not be added as sole agent to a failing regimen. Whenever a change in anti-retroviral therapy is considered because of therapeutic failure, at least 2 components of the previous regimen should be changed since adding a 54
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single new agent may predispose to the development of viral resistance. Use of an entirely new regimen containing at least 3 drugs is preferred. The effect of Efavirenz therapy on subsequent therapy with other nonnucleoside reverse transcriptase inhibitors remains to be determined. Because cross-resistance occurs among non-nucleoside reverse transcriptase inhibitors, most clinicians suggest that individuals who experience disease progression while receiving one of the agents (e.g., Delavirdine, Efavirenz, Nevirapine) should not be switched to another agent in the class. As Efavirenz has been associated with adverse CNS effect, patients should be advised that the drug may impair their ability to perform hazardous activities requiring mental alertness or physical coordination such as operating machinery or driving a motor vehicle. In addition, patients receiving Efavirenz should be informed that there is a potential for additive CNS effects if they use Efavirenz concomitantly with psychoactive drugs or alcohol. Patients should be advised to contact their clinician if they experience delusions, inappropriate behaviour, or acute depression while receiving Efavirenz; discontinuance of the drug may be necessary in patients who experience such CNS effects. Efavirenz is metabolized in the liver; the drug should be used with caution in patents with hepatic impairment. Serum hepatic enzyme concentrations should be monitored during Efavirenz therapy in patients who have, or may have, Hepatitis B and/or C virus infection, in patients receiving concomitant Ritonavir and in patients receiving concomitant therapy with hepatotoxic drug(s). In patients with serum hepatic enzyme concentrations more than 5 times the upper limit of normal, the benefits of continued Efavirenz therapy versus the risks of hepatotoxicity should be considered. Because increases in serum cholesterol concentration have occurred in individuals receiving Efavirenz, cholesterol monitoring should be considered in patients receiving the drug. Because of the risk of foetal malformations, Efavirenz should not be used in women who are or may become pregnant unless no other therapeutic options exist. Precautions Efavirenz may cause drowsiness or dizziness. Alcohol may intensify this effect. Paediatric Precautions Safety and efficacy of Efavirenz in neonates and children younger than 3 years of age or who weigh less than 13 kg have not been evaluated. 55
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Adverse effects including CNS, gastrointestinal and dermatologic effects reported in children receiving Efavirenz are similar to those reported in adults receiving the drug. Adverse CNS effects occurred in 9% of children receiving Efavirenz. In clinical studies rash has been reported more frequently in children than adults (40 vs 27.3% ) and the incidence of moderate to severe rash has been greater in children than adults. Because of the high incidence of dermatologic reactions in children, antihistamines may be used for the prevention of rash when initiating Efavirenz therapy in children; however, the efficacy of such a strategy has not been determined. Side Effects Central Nervous System (CNS) : Dizziness, impaired concentration, abnormal dreams and insomnia have been reported in about 52% of adults receiving Efavirenz 600 mg once daily. In clinical studies these adverse effects were reported in 26% of adults in the control groups not receiving Efavirenz. In adults receiving Efavirenz, these CNS effects were described as mild (do not interfere with daily activities) in 31.4%, moderate (may interfere with daily activities) in 17.8% or severe (interrupt usual daily activities) in 2.6% cases. Adverse nervous system effects generally begin during the first 1-2 days of drug therapy, improve with continued therapy and usually resolve after the first 1-2 days of therapy. Adverse CNS effects may be more tolerable if the daily dose of Efavirenz is administered at bedtime, especially during the first 2-4 weeks of therapy and in patients who continue to experience such effects. Fatigue has been reported in up to 7% of adults receiving the drug in clinical studies. Severe acute depression, sometimes accompanied by suicidal ideation/ attempts, has been reported rarely in patients receiving Efavirenz in clinical studies. Adverse CNS effects reported in less than 2% of patients receiving Efavirenz include ataxia, confusion, impaired coordination, migraine headache, neuralgia, paresthesia, peripheral neuropathy, seizures, speech disorder, tremor, or vertigo. In addition, aggravated depression, agitation, amnesia, anxiety, apathy, emotional liability, euphoria, hallucination, or psychosis has occurred in less than 2% of Efavirenz-treated patients.
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Adverse CNS effects occurred in 9% of children receiving Efavirenz in clinical studies. Dermatologic reactions : Rash has occurred in 27. 3% of adults receiving Efavirenz in clinical studies and in 17% of adults in control groups not receiving the drug. Pruritus or increased sweating has been reported in 12% of patients receiving the drug. Allergic reaction, alopecia, eczema, folliculities, skin exfoliation or urticaria has occurred in lees than 2% of patients receiving the drug. Gastrointestinal : Nausea or diarrhoea has been reported in up to 12% of adults receiving the drug. Vomiting, dyspepsia, abdominal pain, or flatulence has occurred in some Efavirenz-treated adults. Dry mouth or taste change has been reported in up to 2% of patients receiving the drug. Hepatic : Hepatitis occurred in less than 2% of patients receiving the drug. Cardiovascular : While the clinical importance remains to be determined, total serum cholesterol concentrations have been increased 10-20% in healthy individuals receiving the drug. Hot flushes, flushing, palpitations, tachycardia, or thrombophlebitis has been reported in less than 2%, of patients receiving the drug. Pharmaceutical Precautions Store in a cool dry place. Keep out of reach of children. Commercial Pack Avifanz Tablet : Each box contains 1 x 10’s tablets in blister strip. Each tablet contains Efavirenz INN 600 mg.
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Avifix® Tablet
Description Avifix (Nelfinavir Mesylate), a human immunodeficiency virus (HIV) protease inhibitor, is available as film coated tablet in 250 mg strength (as Nelfinavir free base). Indications Avifix is indicated for the treatment of HIV infection when antiretroviral therapy is warranted. Dosage and Administration Adults: The recommended dose is 1250 mg (five 250 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. Avifix should be taken with meal. Antiviral activity is enhanced when Avifix is administered in combination with nucleoside analogues. Therefore, it is recommended that Avifix be used in combination with nucleoside analogues. Paediatric Patients : The recommended oral dose of Avifix for paediatric patients 2 to 13 years of age is 20-30 mg/kg per dose, three times daily with a meal. Contraindication Avifix is contraindicated in patients with clinically significant hypersensitivity to any of its components. Co-administration of Avifix is contraindicated with drugs that are highly dependent on cytochrome P450 3A (CYP3A) for clearance and for which elevated plasma concentrations are associated with serious and/or lifethreatening adverse events. Warning and Precautions Avifix should not be administered Astemizole, Cisapride, Triazolam, Amiodarone or Quinidine because metabolism of these drugs and create threatening adverse events. 58
concurrently Midazolam, Avifix may potential for
with Terfenadine, ergot derivatives, affect the hepatic serious and/or life-
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New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus and hyperglycaemia have been reported during post-marketing surveillance in HIV-infected patients receiving protease inhibitor therapy. Some patients required either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. In some cases diabetic ketoacidosis has occurred. In those patients who discontinued protease inhibitor therapy, hyperglycaemia persisted in some cases. Precautions for Special Population Hepatic Impairment : Nelfinavir is principally metabolized by the liver. Therefore, caution should be exercised when administering this drug to patients with hepatic impairment. Haemophilias : There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis, in patients with haemophilia type A and B treated with protease inhibitors. In some patients, additional factor VIII was given. In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced. A causal relationship has not been established. Paediatric : A similar adverse event profile was seen during the paediatric clinical trial as in adult patients. The evaluation of the antiviral activity of Nelfinavir in paediatric patients is ongoing. The safety, effectiveness and pharmacokinetics of Nelfinavir have not been evaluated in paediatric patients below the age of 2 years. Use in Pregnancy and Lactation There are no adequate and well-controlled studies in pregnant women. To avoid postnatal transmission of HIV, the US Public Health Service Centers for Disease Control and Prevention advises HIV-infected women not to breast feed their infants. Side Effects The safety of Nelfinavir was studied in over 1500 patients who received the drug either alone or in combination with nucleoside analogues. The majority of adverse events were of mild intensity. The most frequently reported adverse event among patients receiving Nelfinavir was diarrhoea, which was generally of mild to moderate intensity.
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Adverse events occurring in less than 2% of patients receiving Nelfinavir in all phase II/III clinical trials are considered at least possibly related or of unknown relationship to treatment. They are listed belowGeneral : abdominal pain, accidental injury, allergic reaction, asthenia, back pain, fever, headache, malaise, pain and redistribution/accumulation of body fat. Digestive System : anorexia, dyspepsia, epigastric pain, gastrointestinal bleeding, hepatitis, mouth ulceration, pancreatitis and vomiting. Haematologic : anaemia, leucopenia and thrombocytopenia. Metabolic/Nutritional : increase in alkaline phosphate, amylase, CPK, lactic dehydrogenase, asparpate transaminase (AST), ALT and gamma glutamyl transpeptidase. Hyperlipaemia, hyperuricaemia, hyperglycaemia, hypoglycaemia, dehydration, and abnormal liver function tests. Musculoskeletal System : arthralgia, arthritis, cramps, myalgia, myasthenia and myopathy. Nervous System : anxiety, depression, dizziness, emotional lability, hyperkinesia, insomnia, migraine, paresthesia, seizures, sleep disorder, somnolence and suicide ideation. Respiratory System : dyspnoea, pharyngitis, rhinitis and sinusitis. Skin/Appendages : dermatitis, folliculitis, fungal maculopapular rash, pruitus, sweating, and urticaria.
dermatitis,
Special Senses : acute iritis and eye disorder. Urogenital System : kidney calculas, sexual dysfunction and urine abnormality. Overdosage Human experience of acute overdose with Avifix is limited. There is no
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specific antidote for overdose with Avifix. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid removal of unabsorbed drug. Since Nelfinavir is highly protein bound, dialysis is unlikely to significantly remove the drug from blood. Drug Interactions Nelfinavir is an inhibitor of CYP3A (cytochrome P450 3A). Coadministration of Avifix and drugs primarily metabolized by CYP3A (e.g., dihydropyridine calcium channel blockers) may result in increased plasma concentrations of the other drug that could increase or prolong both its therapeutic and adverse effects. Co-administration of drugs that inhibit CYP3A may increase Nelfinavir plasma concentration. Drugs that Should not be Co-administered with Avifix
Class
Drug
Antiarrhythmics Antihistamines Antimigraine Antimycobacterial agents Benzodiazepines Gastrointestinal motility agents
Amiodarone, Quinidine Astemizole, Terfenadine Ergot derivatives Rifampin Midazolam, Triazolam Cisapride
Drugs which Require a Dose Reduction when Co-administered with Avifix
Class
Drug
Antimycobacterial agents
Rifabutin
Based on known metabolic profiles, clinically significant drug interactions are not expected between Avifix and Dapsone, Trimethoprim/Sulfamethoxazole, Clarithromycin, Erythromycin, Itraconazole or Fluconazole. Anti-HIV Protease Inhibitors Indinavir : Co-administration of Indinavir with Nelfinavir resulted in an 83% increase in Nelfinavir plasma AUC and a 51% increase in Indinavir plasma antioxidant capacity (AC). Currently, there are no safety and efficacy data available from the use of this combination.
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Other Potentially Clinically Significant Drug Interactions with Avifix * Anticonvulsants : Carbamazepine
May decrease Nelfinavir plasma concentrations**
Anti-HIV protease inhibitors : Indinavir
May increase Nelfinavir plasma concentrations
Oral contraceptives : Ethinyloestradiol
Plasma concentrations may be decreased by Avifix
* This table is not all inclusive ** Avifix may not be effective due to decreased Nelfinavir plasma concentrations in patients taking these agents concomitantly
Ritonavir : Co-administration of Ritonavir with Avifix resulted in a 152% increase in Nelfinavir plasma (area under the plasma concentration x time curve) AUC and very little change in Ritonavir plasma AC. Currently, there are no safety and efficacy data available from the use of this combination. Saquinavir : Co-administration of Saquinavir (using an experimental softgelatin capsule formulation of Saquinavir 1200 mg) with Avifix resulted in an 18% increase in Nelfinavir plasma AUC and a 4-fold increase in Saquinavir plasma AC. If used in combination with Saquinavir hard gelatin capsules at the recommended dose of 600 mg tid, no dose adjustments are needed. Currently, there are no safety and efficacy data available from the use of this combination with antifungal agents. Anti-HIV Reverse Transcriptase Inhibitors Didanosine : It is recommended that Didanosine be administered on an empty stomach; therefore, Nelfinavir should be administered (with food) one hour after or more than two hours before Didanosine. Zidovudine : Co-administration of Zidovudine and Lamivudine with Avifix resulted in a 35% decrease in Zidovudine plasma AC. A dose adjustment is not needed when Zidovudine is administered with Avifix. Little or no change in the pharmacokinetics of either drug was observed when Avifix was co-administered with Lamivudine or Stavudine.
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Pharmaceutical Precautions Store below 30° C in a dry place. Keep out of reach of children. Commercial Pack Avifix Tablet : Each box contains 1 x 10’s tablets in blister strip. Each tablet contains Nelfinavir Mesylate INN equivalent to 250 mg Nelfinavir.
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Avilam® Tablet Description Avilam(formerly known as 3TC) is the brand name for Lamivudine, a synthetic nucleoside analogue with activity against HIV. Indications Avilamin combination with Zidovudine is indicated for the treatment of HIV infection. Dosage and Administration Adults and Adolescents (12 to 16 years) : The recommended oral dose of Avilam for adults and adolescents is 150 mg twice daily administered in combination with Zidovudine. For adults with low body weights (less than 50 kg or 110 lb), the recommended oral dose of Avilam is 2 mg/kg twice daily administered in combination with Zidovudine. No data are available to support a dosage recommendation for adolescents with low body weight (less than 50 kg). Paediatric Patients : The recommended oral dose of Avilam for paediatric patients of age between 3 months to up to 12 years is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day) administered in combination with Zidovudine. Dose Adjustment It is recommended that doses of Avilam be adjusted in accordance with renal function in patients older than age 16 years (see following table). Insufficient data are available to recommend a dosage of Avilam in patients undergoing dialysis. Contraindication Avilam is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the product. Warning and Precautions In paediatric patients with a history of pancreatitis or other significant risk factors for the development of pancreatitis, the combination of 64
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Table : Adjustment of Dosage of Avilam in Accordance with Creatinine Clearance Creatinine Clearance (mL/min) >50 30-49 15-29 5-14 5% frequency during therapy with Lamivudine 150 mg bid plus Zidovudine 200 mg tid compared with Zidovudine are listed in the following table. Selected Clinical Adverse Events (>5% Frequency) in Four Controlled Clinical Trials Adverse Event
Lamivudine 150 mg bid plus Zidovudine (n = 251)
Zidovudine (n = 230)
35 % 27 % 10 %
27 % 23 % 12 %
33 % 18 % 10% 9% 6% 5%
29% 22% 7% 11% 3% 5%
General Headache Malaise and fatigue Fever or chills Digestive Nausea and vomiting Diarrhoea Anorexia and/or decreased appetite Abdominal pain Abdominal cramps Dyspepsia Nervous system Neuropathy Insomnia and other sleep disorders Dizziness Depressive disorders
12% 11% 10% 9%
10% 7% 4% 4%
Respiratory Nasal signs and symptoms Cough
20% 18%
11% 13%
Skin Skin rashes
9%
6%
Musculoskeletal Musculoskeletal pain Myalgia Arthralgia
12% 8% 5%
10% 6% 5%
Observed During Clinical Practice : The events identified during use of the drug in clinical practice include alopecia, anaphylaxis, hyperglycaemia, lactic acidosis and hepatic steatosis, peripheral neuropathy, pruritus, rash, urticaria, and weakness.
Overdosage There is no known antidote for Lamivudine. It is not known whether Lamivudine can be removed by peritoneal dialysis or haemodialysis.
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Pharmaceutical Precautions Store in a cool dry place. Protect from light. Keep out of reach of children. Commercial Pack Avilam Tablet : Each box contains 1 x 10’s tablets in blister strip. Each tablet contains Lamivudine INN 150 mg.
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Avitron® V Tablet
Description Avitron V tablet contains Vitamin B1 or Thiamine Hydrochloride USP. Thiamine Hydrochloride is a water soluble vitamin belongs to vitamin Bcomplex family. Thiamine in the form of Thiamine Pyrophosphate (also known as cocarboxylase), is the co-enzyme for decarboxylation of α-keto acids. Thiamine pyrophosphate also acts as the co-enzyme of transketolase in the direct oxidation pathway of glucose metabolism. In thiamine deficiency, pyruvic acid and lactic acid accumulate in tissues. Thiamine deficiency affects the peripheral nervous system, the gastrointestinal tract, and the cardiovascular system. Thiamine is not stored in the body, intracellular thiamine is present almost entirely as the co-enzyme moiety of active enzymes. Thiamine requirement is related to carbohydrate intake and the metabolic rate. A daily intake of 400 mg thiamine per 1000 kcal is recommended. The total requirement increases during periods of active growth or heavy physical labour, during pregnancy and lactation, in pathological conditions such as fever and hyperthyroidism and in other conditions causing increased metabolism. Indications Avitron V is indicated in the treatment of the various manifestations of thiamine deficiency such as beriberi (wet or dry) and Wernicke's encephalopathy, neuritis associated with pregnancy and pellagra. Supplementary thiamine may be indicated prophylactically in conditions where there is low dietary intake or low gastrointestinal absorption of thiamine, and increased thiamine requirement periods e.g. - active growth - heavy physical labour - pregnancy and lactation - in pathological conditions such as fever and hyperthyroidism and other conditions causing increased metabolism.
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Dosage and Administration Mild chronic deficiency : 10-25 mg daily Severe deficiency : 200-300 mg daily or as advised by the physician Contraindication Thiamine is contraindicated in patients with known hypersensitivity to it. Side Effects Vitamin B1 does not have adverse effects when given orally. A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness etc. may occur. Pregnancy and Lactation Thiamine is safe in pregnant women and recommended for the treatment of neuritis in pregnancy. Although it is not known if thiamine is excreted in breast milk, the drug may be taken safely during lactation. Pharmaceutical Precaution Store in a cool and dry place, protected from light. Commercial Pack Avitron V Tablet : Box containing 25 blister strips of 10 tablets. Each tablet contains Thiamine Hydrochloride USP 100 mg.
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Axodin® Tablet
Description Axodin (Fexofenadine), a pharmacologically active metabolite of Terfenadine, is a non-sedating antihistamine with selective peripheral H1 receptor antagonist activity. Fexofenadine Hydrochloride is rapidly absorbed into the body following oral administration, with T max occurring at approximately 1-3 hours post dose. The mean Cmax value was approximately 427 ng/ml and 494 ng/ml following the administration of a 120 mg and 180 mg dose (once daily) respectively. Fexofenadine is 60-70% plasma protein bound. Fexofenadine undergoes negligible metabolism, as it was the only major compound identified in urine and faeces of animal and human. The plasma concentration profiles of Fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 to 16 hours after multiple dosing. The single and multiple dose pharmacokinetics of Fexofenadine are linear between 40 mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion while up to 10% of ingested dose is excreted unchanged through the urine. Indications Axodin is indicated for the relief of symptoms associated with allergic rhinitis and allergic skin conditions e.g. chronic urticaria. Dosage and Administration ♦ Allergic rhinitis Children 6 to 11 years The recommended dose of Fexofenadine Hydrochloride is 30 mg twice daily. Adults and children aged 12 years and over The recommended dose of Fexofenadine Hydrochloride for adults and children aged 12 years and over is 120 mg once daily. 70
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Allergic skin conditions, e.g. chronic urticaria Children 6 to 11 years The recommended dose of Fexofenadine Hydrochloride is 30 mg twice daily. Adults and children 12 years and over The recommended dose of Fexofenadine Hydrochloride for adults and children aged 12 years and over is 180 mg once daily. Children under 6 years of age The efficacy and safety of Fexofenadine Hydrochloride has not been studied in children under 6.
Use in Special Risk Group Studies in special risk groups (elderly and patients with renal or hepatic impairment) indicate that it is not necessary to adjust the dose of Fexofenadine Hydrochloride in these patients. Contraindication The product is contraindicated in patients with known hypersensitivity to any of its ingredients. Drug Interactions Fexofenadine does not undergo hepatic bio-transformation and is therefore unlikely to interact with drugs that rely upon hepatic metabolism. Fexofenadine Hydrochloride at doses of 120 mg twice daily has been safely co-administered with Erythromycin (500 mg three times daily) and Ketoconazole (400 mg once daily) under steady state conditions in healthy volunteers. A two fold increase in the level of plasma Fexofenadine was observed after co-administration of Erythromycin or Ketoconazole but this was not associated with any increase in adverse event or effects on the QT interval, compared to that seen when the drugs were given alone. Animal studies have shown that the increase in plasma level of Fexofenadine observed after co-administration of Erythromycin or Ketoconazole appears to be due to an increase in gastrointestinal absorption.
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Side Effects In placebo-controlled trials, adverse events were comparable in Fexofenadine and placebo treated patients. Adverse events reported with Fexofenadine includeCommon : headache, Uncommon : fatigue, drowsiness, nausea, tachycardia, palpitations, dry mouth, dyspepsia and gastrointestinal disturbances (including diarrhoea), Rare : taste, disturbances, anaphylactic reactions, dyspnoea, chest tightness, increased hair loss/hair thinning, photosensitivity, dysmenorrhoea, menstrual disorders, Others : As with other non-sedating antihistamines, dizziness, nervousness, agitation, sleep disorders, insomnia or paroniria may infrequently be reported by patients. The incidence of such reports under Fexofenadine was similar to the incidence under placebo. Effects on ability to Drive and Use Machines On the basis of the pharmacodynamics profile and reported adverse events it is unlikely that Fexofenadine Hydrochloride will produce an effect on the ability to drive or use machines. In objective tests, Fexofenadine Hydrochloride has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. Overdosage Most reports of Fexofenadine Hydrochloride overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported. Single doses up to 800 mg and doses up to 690 mg bid for 1 month or 240 mg qid for 1 year were studied in healthy subjects without the development of clinically significant adverse events as compared to placebo. Use in Pregnancy and Lactation Fexofenadine should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus. There are no data on the content of human milk after administering Fexofenadine Hydrochloride. However, when Terfenadine was administered to nursing mothers Fexofenadine was found to cross into human breast milk. Therefore Fexofenadine is not recommended for mothers breast feeding their babies.
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Pharmaceutical Precautions Store in cool and dry place. Keep away from children. Commercial Pack Axodin 60 Tablet : Each tablet contains Fexofenadine Hydrochloride 60 mg in 10 x 5 blister strips. Axodin 120 Tablet : Each tablet contains Fexofenadine Hydrochloride 120 mg in 10 x 5 blister strips. Axodin 180 Tablet : Each tablet contains Fexofenadine Hydrochloride 180 mg in 10 x 3 blister strips.
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Azithrocin® Capsule/Tablet/Suspension
Description Azithrocin contains Azithromycin USP. It is an azalide antibiotic active against Gram-positive and Gram-negative organisms. Azithromycin interferes with ribosome function in susceptible bacteria by inhibiting the translocation of peptides. Indications Azithrocin (Azithromycin) is indicated for infections caused by susceptible organisms, in upper respiratory tract infections including sinusitis, pharyngitis and tonsillitis, in lower respiratory tract infections including bronchitis and pneumonia, skin and soft tissue infections, and otitis media. Azithrocin is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis. Dosage and Administration Adult : Azithrocin should be given as 500 mg once-daily orally for 3 days or as an alternative, given over 5 days with 500 mg on day 1, then 250 mg on days 2-5. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 g given as a single dose. Normal adult dose is recommended for elderly patients. For children over 6 months recommended dose is 10 mg/kg once daily for 3 days; or if body weight is 15-25 kg : 200 mg once daily for 3 days, if body weight is 26-35 kg : 300 mg once daily for 3 days, if body weight is 36-45 kg : 400 mg once daily for 3 days. As common with many other antibiotics, Azithrocin should be taken at least 1 hour before or 2 hours after meal and antacid.
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Contraindication Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases. Side Effects Azithromycin is well tolerated with a low incidence of side effects. Majority of the side effects were mild to moderate in nature and of gastrointestinal in origin with nausea, abdominal discomfort, vomiting, flatulence and diarrhoea. Allergic reactions such as rash have occurred and there have also been rare reports of serious hypersensitivity reactions. Reversible elevations in liver transaminases have been seen with a frequency similar to the comparative macrolides and penicillins used in clinical trials. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although a causal relationship to Azithromycin has not been established. Precautions As with any antibiotic, observation for signs of superinfection with nonsusceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment. Use in Pregnancy and Lactation Animal reproduction studies have demonstrated that Azithromycin crosses the placenta, but have revealed no evidence of harm to the foetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. No data on secretion of Azithromycin in breast milk is available, so, Azithromycin should only be used in lactating mothers where adequate alternatives are not available. Drug Interactions Azithromycin absorption is reduced in presence of food and antacid. So, Azithromycin should be administered 1 hour before or 2 hours after taking food or antacid. In patients receiving ergot alkaloids, Azithromycin should be avoided concurrently because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P450 75
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system. However, no cases of such interaction have been reported. Macrolides have been known to increase the plasma concentration of Digoxin and Cyclosporin. Therefore, if co-administration is necessary, caution should be exercised and serum level of Digoxin and Cyclosporin should be checked. There have been no pharmacokinetic drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone and Cimetidine. Overdosage There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated. Commercial Pack Azithrocin Capsule : Box containing 1 x 10’s blister strip, each capsule contains Azithromycin USP equivalent to 250 mg anhydrous Azithromycin. Azithrocin 500 Tablet : Box containing 1 x 3’s blister strip, each film coated tablet contains Azithromycin USP equivalent to 500 mg anhydrous Azithromycin. Azithrocin Suspension : Dry powder in glass bottle for reconstitution into 15 ml of suspension. After reconstitution each 5 ml contains Azithromycin USP equivalent to 200 mg anhydrous Azithromycin.
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Azmasol ® Inhaler
Description Salbutamol BP, the active ingredient of Azmasol Inhaler, is a ß2 adrenoceptor agonist used in the treatment of asthma and other forms of diffuse reversible airways obstruction. Indications Azmasol (Salbutamol) inhaler is indicated for the treatment and prophylaxis of bronchial asthma and for the treatment of reversible airways obstruction associated with bronchitis and emphysema. Azmasol inhaler may be used to relieve attacks of acute dyspnoea and may also be taken prophylactically before exertion or to prevent exercise-inducedasthma. It is suitable for treating bronchospasm in patients with coexisting heart disease or hypertension, including those taking βblockers, because of its selective action on the bronchial receptors and lack of effects on the cardiovascular system. Salbutamol is a sympathomimetic agent which has a highly selective action on βadrenergic receptors in bronchial muscle. At therapeutic levels, it has little effect on cardiac receptors. Dosage and Administration Adults i) For the relief of acute bronchospasm and for managing intermittent episodes of asthma : one or two inhalation as a single dose ii) For chronic maintenance or prophylactic therapy : two inhalations three or four times daily iii) For prevention of exercise induced bronchospasm : two inhalations before exertion. Children For relief of acute bronchospasm, management of episodic asthma and for prevention of exercise induced bronchospasm : one inhalation; for routine maintenance and prophylaxis : one inhalation three or four times daily, increasing if necessary to two inhalations three or four times daily. 77
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Elderly The dosage is the same as that for adults. Contraindication Although intravenous Salbutamol, and occasionally Salbutamol tablets, are used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy, Salbutamol inhaler preparations are not appropriate for managing premature labour. Salbutamol preparation should not be used for threatened abortion during the first or second trimesters of pregnancy. Salbutamol inhaler is contraindicated in patients with a history of hypersensitivity to any of its components. Precautions In the event of previously effective dose of Salbutamol inhaler failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken. Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis. As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy should be instituted. Side Effects Mild tremor and headache have been rarely reported. These usually disappear with continuous treatment. There have been very rare reports of transient muscle cramp. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. Pharmaceutical Precaution Pressurized canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from eyes. Keep away from children.
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Commercial Pack Azmasol Inhaler : Each canister contains 200 measured doses, each containing 100 µg of Salbutamol BP. Azmasol Refill Can : Each canister contains 200 measured doses, each containing 100 µg of Salbutamol BP.
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Bexidal® Tablet
Description Each tablet contains Mebhydrolin 50 mg as Mebhydrolin Napadisylate BPC. Indications Allergic diseases or symptoms, such as urticaria, pruritus of various origin, eczema, drug rash, allergic conjunctivitis, dermatitis of nutritional origin, hay fever, vasomotor rhinitis, allergic asthma. Dosage and Administration Unless otherwise prescribed, the following doses are recommended: Adults and children over 10 years .................. 2-6 tablets daily Children from 5-10 years ............................. 2-4 tablets daily Children from 2-5 years ............................ 1-3 tablets daily Children up to 2 years ................................. 1-2 tablets daily Treatment should be given in several single doses daily. Bexidal may be swallowed during or shortly after meals. For children, the tablets may be crushed and mixed with food. Bexidal is essentially free from secondary sedative-hypnotic effects. It does not impair psycho-physical efficiency to any appreciable degree. Contraindication ♦ Caution is required while driving or operating heavy machinery ♦ Concomitant use of CNS depressant or alcohol ♦ Patients to whom Mebhydrolin has previously been suspected to have agranulocytosis or neutropenia ♦ First trimester of pregnancy Commercial Pack Bexidal Tablet : Box containing 20 aluminium strips of 10 tablets. Each tablet contains Mebhydrolin 50 mg as Mebhydrolin Napadisylate BPC. 80
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Bexitrol-F ® Inhaler
Description Bexitrol-F metered dose inhaler is a combination of Salmeterol Xinafoate INN and Fluticasone Propionate BP. Salmeterol Xinafoate is a selective, long acting β2 agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systematic effects at usual dose. Indications Bexitrol-F is indicated in the regular treatment of asthma where use of a combination product (long-acting β 2 agonist and inhaled corticosteroid) is appropriate. Other indication of Bexitrol-F is patients with frequent asthmatic episodes requiring bronchodilators or those with asthmatic episodes at night. Pharmacodynamic Properties Mechanism of action : Bexitrol-F contains Salmeterol and Fluticasone Propionate, which have different modes of action. Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. Bexitrol-F can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The mechanisms of action of both drugs are discussed below: Salmeterol : Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor. Fluticasone Propionate : Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, without the adverse effects observed when corticosteroids are administered systemically.
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Recommended Doses Adults and adolescents 12 years and olderThe recommended dose is two puffs of Bexitrol-F twice daily or as prescribed by the physicians. Contraindication Bexitrol-F is contraindicated in patients with a history of hypersensitivity to any of the ingredients of the product. Special Warning and Precautions Consideration should be given to additional corticosteroid therapies, and administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, Bexitrol-F should be administered with caution in patients with active or quiescent pulmonary tuberculosis. Bexitrol-F should be administered with caution in patients with thyrotoxicosis. Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown. Drug Interactions Both non-selective and selective β-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. Care should be taken when coadministering known strong CYP3A4 (cytocrome P450 3A4) inhibitors (e.g. Ketoconazole, Ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate. Use in Pregnancy and Lactation There is insufficient experience of the use of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no data available for human breast milk. Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child.
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Side Effects As Bexitrol-F contains Salmeterol and Fluticasone Propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Adverse events, which have been associated with Salmeterol or Fluticasone Propionate, are given below. Salmeterol : The pharmacological side effects of β2 agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduced with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of oropharyngeal irritation, arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been rare reports of muscle cramps. Fluticasone Propionate : Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Bexitrol-F Inhaler. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Overdosage There are no data available from clinical trials on overdosage with this combination drug. Pharmaceutical Precaution Pressurized canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30o C. Keep away from eyes. Keep away from children. Commercial Pack Bexitrol-F Inhaler : Each canister contains 120 metered doses, each containing Salmeterol Xinafoate INN equivalent to 25 µg Salmeterol and Fluticasone Propionate BP 250 µg.
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Bexitrol ® Inhaler
Description Salmeterol Xinafoate INN, the active ingredient of Bexitrol Inhaler, is a selective, long acting ß2 -agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Bexitrol Inhaler is a metered dose aerosol unit containing a micro-crystalline suspension of Salmeterol in a mixture of propellant with lecithin. Indications Bexitrol (Salmeterol) is a long-acting ß2-agonist which is considerably more potent, selective and long-acting compared with traditionally used bronchodilators. Bexitrol protects against asthma induced by histamine or methacholine for a period of at least 12 hours in adults and children. Furthermore, long-acting ß2 -agonist show a more than 4-fold greater potency than short-acting agents (for example, Salbutamol) against histamine-induced bronchoconstriction. Bexitrol has the potential to improve the treatment of patients with asthma; the drug provides prolonged bronchodilation and decrease asthma symptoms and the need for short acting ß2-agonist, independently of concomitant steroid use. Studies have consistently reported improved control of nocturnal asthma with long-acting ß2-agonist compared with other anti-asthma drugs. Bexitrol is indicated for the long term regular treatment of reversible airways obstruction (including nocturnal and exercise-induced asthma) and chronic bronchitis. In paediatric asthma, the use of Bexitrol may avoid exposure of children to Theophylline or high-dose corticosteroids, with their attendant risks. Dosage and Administration The recommended dose is 50 µg (2 puffs) twice daily, although in severe disease the dose may be increased to 100 µg twice daily. The drug should not be used on an ‘as required’ basis, although on account of its efficacy in nocturnal and exercise induced asthma, single dose administration may be considered as a treatment option.
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Contraindication Patients with thyrotoxicosis. Special caution should be exercised in patients with cardiac problems predisposing to arrythmias. The drug is ineffective in patients taking non-selective ß-blocking drugs. Precautions Bronchodilators should not be the only or the main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment, including lung function testing, as patients are at risk of severe attack or even death. Physicians should consider using oral corticosteroid therapy and/or the maximum recommended dose of inhaled corticosteroid in these patients. Increasing use of bronchodilators, in particular short-acting inhaled ß2 -agonist to relieve symptoms indicates deterioration of asthma control. If patients find that short acting bronchodilator treatment becomes less effective or they need more inhalation than usual, medical attention must be sought. In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroid or a course of oral corticosteroids). Severe exacerbation of asthma must be treated in the normal way. Salmeterol inhaler is not designed to relieve acute asthmatic symptoms, for which an inhaled short -acting bronchodilator is required. Patients should be advised to have such rescue medication available. Potentially serious hypokalaemia may result from ß 2-agonist therapy. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics. It is recommended that serum potassium levels are monitored in such situations. Side Effects No severe irreversible adverse effect is known although systemic ß2 agonist effects of Salmeterol may last up to 12 hours. Inhaled dose of Salmeterol up to 400 µg given to healthy volunteers produced significant systemic side effects, the majority of which were pharmacologically predictable. Response observed with 100 µg Salmeterol were similar to those observed with 400 µg Salmeterol. Hypokalaemia, tremor and palpitations may all occur but only at doses of Salmeterol exceeding that recommended.
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Pharmaceutical Precaution Store below 30°C, keep out of the reach of children. Commercial Pack Bexitrol Inhaler : Each canister contains 200 metered doses, each containing Salmeterol Xinafoate INN equivalent to 25 µg Salmeterol.
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Bextrum® Tablet
Description Bextrum is a special formulation comprising of important vitamins, antioxidants and minerals. Each film-coated tablet contains: Vitamin A Vitamin E Vitamin K Vitamin C Thiamine Mononitrate Riboflavin Folic Acid Niacin Pantothenic Acid Pyridoxine Hydrochloride Iron Zinc Copper Manganese Iodine Selenium Molybdenum Chromium Inositol Quercetin
2700 IU 30 IU 65.00 µg 120.00 mg 3.40 mg 3.40 mg 800 µg 40.00 mg 20.00 mg 10.00 mg 30.00 mg 25.00 mg 2.00 mg 1.20 µg 175.00 µg 12.50 µg 25.00 µg 25.00 µg 50.00 mg 54.00 µg
Indications Bextrum is a once-daily tablet indicated for use to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. This preparation can also be beneficial in improving the nutritional status of women prior to conception. Bextrum tablet maintains a healthy body and active lifestyle and keeps nutrition covered for all. Dosage and Administration Bextrum may be administered once daily or as indicated by the physician. 87
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Contraindication Bextrum is contraindicated in patients with a known hypersensitivity to any of the ingredients. Side Effects Generally well tolerated. Precautions Long-term intake of high levels of vitamin A (excluding that source from β carotene) may increase the risk of osteoporosis in postmenopausal women. Drug Interactions No drug interactions have been reported. Use in Pregnancy and Lactation Bextrum is recommended in pregnancy and lactation. Pharmaceutical Precaution Tablets should be stored below 25 oC and protected from light and moisture. Commercial Pack Bextrum Tablet : Plastic bottle containing 30 tablets. Each tablet contains multivitamin and multimineral.
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Bronkolax® Tablet/Syrup
Description Bronkolax (Salbutamol) is a synthetic sympathomimetic agent having β 2adrenergic activity and selective action on receptors of bronchial smooth muscle. It is used for the treatment of reversible obstruction of the airways. Indications Bronkolax is indicated for the relief of bronchospasm in bronchial asthma, bronchitis, emphysema and also in bronchospasm where heart disease or hypertension is co-existing. Dosage and Administration Adults Recommended dose is 2-4 mg, 3-4 times daily; in some patients higher doses up to 8 mg may be given. Children Recommended dose for age group2-6 years : 1 mg, 3-4 times daily 6-12 years : 2 mg, 3-4 times daily Over 12 years : 2-4 mg, 3-4 times daily Contraindication It should not be prescribed with β blocking drugs. Bronkolax should not be used for prevention of premature labour associated with toxemia of pregnancy or antepartum hemorrhage or for threatened abortion during the first and second trimester of pregnancy. Precautions Bronkolax should be given with caution to hypersusceptible patients or those with hyperthyroidism, in patients with diabetes mellitus, serious cardiovascular disorders or hypertension. In asthmatic patients, whose condition deteriorates despite Salbutamol therapy, alternative or additional therapy including corticosteroids should be instituted 89
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promptly. Adverse metabolic effects of high doses of Salbutamol may be exacerbated by concomitant administration of high doses of corticosteroids. Hypokalemia associated with high doses of Salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmias. Concomitant administration of Aminophylline may enhance the effects of Salbutamol. Long term treatment may increase the risk of dental caries and hence adequate dental hygiene should be maintained. Side Effects Salbutamol may cause fine tremor of skeletal muscle (particularly the hands), palpitations, and muscle cramps. Slight tachycardia, headache, and peripheral vasodilation have been reported after large doses. Salbutamol may cause hypokalemia and hypoglycaemia. Sometimes hypersensitivity reactions including paradoxical bronchospasm, urticaria and angioedema may occur. Treatment of Overdosage The preferred antidote for overdosage with Salbutamol is a cardioselective beta blocking agent, but beta blocking drugs should be used with caution in patients with a history of bronchospasm. Commercial Pack Bronkolax-2 Tablet : Box containing 100 tablet in 10 x 10’s blister strips, each contains Salbutamol Sulphate BP equivalent to 2 mg Salbutamol. Bronkolax-4 Tablet : Box containing 100 tablet in 10 x 10’s blister strips, each contains Salbutamol Sulphate BP equivalent to 4 mg Salbutamol. Bronkolax Syrup : 100 ml in glass bottle, each 5 ml contains Salbutamol Sulphate BP equivalent to 2 mg Salbutamol.
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Cardopril® Tablet Description Cardopril (Captopril) is the first of a new class of antihypertensive agents, a highly specific competitive inhibitor of angiotensin I converting enzyme. Cardopril is available in 25 mg and 50 mg, as double scored tablets for oral administration. Indications ♦ Hypertension : Mild to moderate hypertension as an adjunct to thiazide therapy in patients who have not responded effectively to thiazide treatment alone. ♦
Severe hypertension : Where standard therapy has failed.
Cardopril is effective alone or in combination with other antihypertensive agents especially thiazide type of diuretics. The blood pressure lowering effect of Cardopril and thiazides are approximately additive. ♦
Congestive heart failure : It is also used as an adjunct to the treatment of severe congestive heart failure.
Dosage and Administration ♦ Hypertension : Treatment with Cardopril should be at the lowest effective dose, which should be titrated according to the need of the patient. Mild to moderate hypertension- In mild to moderate hypertension Cardopril therapy should be used as an adjunct to thiazide therapy. Starting dose is 12.5 mg twice daily. The usual maintenance dose is 25 mg twice daily. Severe hypertension- Starting dose is 12.5 mg twice daily and can be increased incrementally to a maximum of 50 mg thrice daily. ♦
Heart failure : In congestive heart failure an initial dose of 6.25 mg to 12.5 mg is given under close medical supervision.
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The usual maintenance dose is 25 mg thrice daily and should not exceed 50 mg thrice daily. Side Effects Haematological : neutropenia, anaemia and thrombocytopenia. Renal : proteinuria, elevated blood urea and creatinine, elevated serum potassium and acidosis. Cardiovascular : hypotension, tachycardia. Skin : rashes usually pruritic, may occur. Gastrointestinal : Reversible and usually self limiting taste impairment has been reported. Stomatitis resembling aphthous ulcers has also been reported. Drug Interactions ♦ Diuretics: Diuretics potentiate the antihypertensive effect of Captopril. Potassium sparing diuretics (Triamterene, Amiloride and Spironolactone) or potassium supplements may cause significant increase in serum potassium. ♦
Vasodilators: Captopril has been reported to act synergistically with peripheral vasodilators such as Minoxidil.
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Non-steroidal anti-inflammatory agents: Concomitant therapy with Indomethacin and possibly other anti-inflammatory drugs may reduce the antihypertensive effect of Captopril.
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Others: Caution should be exercised in prescribing Captopril for patients receiving concomitant therapy with immuno-suppressant, procainamide, allopurinol and other drugs known to cause neutropenia especially in patients with impaired renal function.
Contraindication A history of previous hypersensitivity to Captopril.
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Precautions Captopril should be used with great caution in patients with impaired renal function particularly if reno-vascular disease is present or suspected and in patient with collagen vascular disorders such as systemic lupus erythematosus or scleroderma. Captopril should not be used during pregnancy. Commercial Pack Cardopril-25 Tablet : Box containing 100 tablets in 10 x 10’s blister strip, each tablet contains 25 mg of Captopril USP. Cardopril-50 Tablet : Box containing 100 tablets in 10 x 10’s blister strip, each tablet contains 50 mg of Captopril USP.
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Carocet® Tablet
Description Carocet is a chewable tablet which contains a combination of three antioxidant vitamins. Each tablet contains β Carotene (pharma grade) 6 mg, Ascorbic Acid USP and Sodium Ascorbate USP equivalent to Ascorbic Acid (Vitamin C) 200 mg and Vitamin E preparation USP equivalent to dl-alpha-Tocopheryl Acetate (Vitamin E) 50 mg. Indications Antioxidant vitamins are used in a wide range of conditions where free radical damage is playing a role. Antioxidant vitamin combination is used in the prevention of coronary heart diseases, certain types of cancer, aging as well as free radical damage caused by excessive exercise, illness, certain medications, air pollution, smoke, radiation and pesticides. The main role of the antioxidant vitamins is as follows: β-carotene prevents free radical formation by quenching singlet oxygen, a highly reactive form of oxygen. Vitamin C is another free radical scavenger which deactivates free radicals. It works specially in the plasma, lung fluid, aqueous humour and interstitial fluid. It can increase white blood cell activity; play important roles in the biochemistry of antibodies, prostaglandin E1, B- and T-lymphocytes, and interferon. Vitamin E also scavenges free radicals in the blood along with β-carotene and vitamin C. Moreover, vitamin E is essential to protect us against some of the ill effects of smog and smoke. In relation to other nutrients vitamin E protects vitamin A from being destroyed in the body. Dosage and Administration Dosage varies according to individual’s need. The usual recommended dose is two tablets daily or as advised by the physician. The dose can be increased up to four tablets daily. Side Effects β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterized by a yellowish 94
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colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids. Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation. Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure. Contraindication There is no absolute contraindication. Warning and Precautions There are some evidences that β-carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs. Use in Pregnancy and Lactation β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women. Drug Interactions Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of certain drugs including oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug-induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K. Overdosage No cases have been reported. Commercial Pack Carocet Tablet : Bottle containing 20 tablets. 95
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Carofol®-Z Capsule
Description Carofol-Z capsule contains Carbonyl Iron INN 50 mg, Folic Acid BP 0.50 mg and Zinc Sulphate Monohydrate USP 61.80 mg. Most ordinary iron products contain iron salts that may cause gastric irritation. But Carofol-Z capsule contains pure iron micro particles called carbonyl iron. This advanced formula is specially designed to be well absorbed, gentle on the stomach and offers enhanced safety in case of an accidental overdose. Folic Acid and Zinc supplementation are also important during pregnancy as because Folic Acid helps to prevent the risk of birth defects like neural tube defects (NTDs) and low birth weight (LBW). Zinc is an important factor to maintain a healthy immune system. Indications The capsule is indicated for the treatment of iron deficiency or iron deficiency anemia, folic acid and zinc deficiency. It is also indicated for prophylactic use when inadequate diet calls for supplementary Zinc, Folic Acid and Iron specially during pregnancy. Dosage and Administration Treatment 2 to 4 capsules a day or as prescribed by the physician. Prophylaxis Adult and elderly : Usually once daily. In severe cases, two capsules a day may be required as prescribed by the physician. Children aged over one year: One capsule a day, the capsule may be opened and the pellets may be mixed with soft, cool food but they must not be chewed. Contraindication It is contraindicated in patients with haemolytic anaemia and in condition with increased hypersensitivity to any of its components and increased body iron content. 96
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Side Effects Side effects of Iron, Folic Acid and Zinc supplementation are mild and transient. These include epigastric pain, nausea, constipation, vomiting, diarrhoea etc. The capsule is specially designed to reduce the possibility of gastrointestinal irritation. Drug Interactions Iron chelates with Tetracycline. Since oral Iron products interfere with absorption of oral Tetracycline antibiotics, these products should not be taken within hours of each other. Occasional gastrointestinal discomfort may be minimized by taking it with meals. Absorption of Iron may be impaired by concurrent administrations of Penicillamine and antacid. Overdosage Overdosage of Iron is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, vomiting may also be induced. Zinc Sulphate in gross overdosage is corrosive. Symptoms are those of gastrointestinal irritation, leading in severe cases to haemorrhagic corrosion of the mucosa and possible later stricture formation. Demulcent such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic acid have been recommended. The extended release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter measures. Precautions Care should be taken in patients who may develop Iron overload, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. In patients with renal failure, a risk of Zinc accumulation may exist. Pharmaceutical Precaution Store capsules in cool and dry place. Keep out of reach of children. Commercial Pack Carofol-Z capsule : Box containing 50 capsules in 5 x 10's blister strips. Each capsule contains Carbonyl Iron INN 50 mg, Folic Acid BP 0.05 mg and Zinc Sulphate Monohydrate USP 61.80 mg.
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Cephalen® Capsule/Suspension
Description Cephalen (Cefalexin) is a semisynthetic antibiotic of the cephalosporin group, intended for oral administration which has a bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Cephalen is acid stable and may be given regardless of meal. It is rapidly absorbed after oral administration and peak serum level is obtained after one hour. It is mainly excreted in the urine. Indications Cephalen is indicated for the treatment of the following infections when caused by susceptible organisms. Respiratory tract infections : Acute and chronic bronchitis and infected bronchiectasis. Genito-urinary tract infections : Acute and chronic nephritis, cystitis, urethritis and prostatitis, prophylaxis of recurrent urinary tract infections. Skin and soft tissue infections : Caused by staphylococci and/or streptococci. Ear, Nose and Throat infections : Otitis media, mastoiditis, sinusitis, follicular tonsillitis and pharyngitis. Bone infections : Caused by staphylococci and/or P. mirabilis. Dosage and Administration Adult : The usual dose is 250 mg to 500 mg every 6 hour. For skin and soft tissue infections, streptococcal pharyngitis and uncomplicated cystitis, in patients over 15 years of age, 500 mg of the drug may be administered every 12 hour. In severe or deep seated infections the dose can be increased up to 3 g to 6 g daily. Children : The dosage range is 25-100 mg/kg/day in divided doses to a maximum of 4 g daily (please note the table below ). 98
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Recommended Dose
10 kg ( 22 Ibs)
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20 kg ( 44 Ibs)
125 mg to 250 mg qid or 250 mg to 500 mg bid
40 kg ( 88 Ibs)
250 mg to 500 mg qid or 500 mg to 1 g bid
For streptococcal pharyngitis, skin and soft tissue infections and in patients over 1 year of age the total daily dose may be divided and administered every 12 hour. In the therapy of otitis media 75-100 mg/kg/day in four divided doses may be required. In the treatment of beta haemolytic streptococcal infections a therapeutic dosage of the drug should be given at least for 10 days. Contraindication Cephalen is contraindicated in patients with known hypersensitivity to the cephalosporin group of antibiotics. Side Effects Side effects include nausea, vomiting, diarrhoea and abdominal discomfort. Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Skin rash, angioedema, rise in serum aminotransferases, eosinophilia, neutropenia have been reported very rarely. Superinfection with resistant micro-organisms, particularly candida may follow the treatment. Precautions Cefalexin should be given with caution in patients with renal impairment. Under such condition, careful clinical observation should be made because safe dosage may be lower than the usually recommended. The urine of patients receiving Cefalexin may give a false positive reaction for glucose with copper reduction reagent. Positive results to Coombs’ test have been reported. Although there is no evidence of teratogenicity in animal tests, Cefalexin may be used during pregnancy when it is considered essential. Cefalexin is found in the milk of nursing mothers, hence caution should be taken when it is administered to nursing mothers. 99
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Commercial Pack Cephalen-250 Capsule : Box containing 10 x 10’s blister strips. Each capsule contains Cefalexin BP equivalent to anhydrous Cefalexin 250 mg. Cephalen-500 Capsule : Box containing 5 x 10’s blister strips. Each capsule contains Cefalexin BP equivalent to anhydrous Cefalexin 500 mg. Cephalen Suspension : Dry powder in amber glass bottle for reconstitution into 100 ml suspension. After reconstitution each 5 ml contains Cefalexin BP equivalent to anhydrous Cefalexin 125 mg.
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Cerivin® Tablet
Description Cerivin (Vinpocetine) increases cerebral metabolism: it increases the glucose and O2 consumption; improves cerebral hypoxia tolerance; shifts glucose metabolism to the energetically more favourable aerobic pathway, but it increases the anaerobic pathway as well; it elevates the ATP concentration and the ATP/AMP ratio in the brain, and elevates the cerebral norepinephrine, dopamine and serotonin levels. Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte derformability; it also promotes O 2 transport into the tissues by reducing the O 2 affinity of erythrocytes. It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance), it does not elicit steal phenomenon, on the contrary, it primarily improves the blood supply of the injured, ischaemic area while it remains unchanged in the intact areas (inverse steal effect), it further increases blood flow which is already increased as a result of hypoxia. Indications All forms of acute and chronic cerebral circulatory insufficiency: TIA (Transient Ischaemic Attack), reversible ischaemic neurological deficiency, progressive stroke, completed stroke, post-apoplectic conditions, multiinfarct dementia, cerebral arteriosclerosis, post traumatic, hypertensive encephalopathy etc. For the reduction of psychic or neurological symptoms of cerebral insufficiency (e.g. memory disturbances, dizziness, headache, aphasia, apraxia, locomotor disorders etc.).
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Ophthalmology: It can be used for the treatment of vascular disorders of the choroid and retina due to arteriosclerosis, vasospasm, macular degeneration, arterial or venous thrombosis or embolism, and glaucoma secondary to the above mentioned disorders. Otology: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin, presbyacusis, Meniere’s disease, cochleovestibular neuritis, tinnitus and dizziness of labyrinth origin. For the treatment of vasovegetative symptoms of climacteric syndrome. Dosage and Administration Cerivin is taken 1-2 tablets three times daily with meals. The maintenance dose is 1 tablet three times daily over long periods. Side Effects Cerivin is well tolerated. In some cases transient fall of blood pressure and tachycardia may occur. Contraindication Cerivin is contraindicated in pregnancy and lactation. Precautions Because Cerivin can reduce the ability of blood to clot, those individuals with a tendency to bleed should avoid Vinpocetine. Drug Interactions Slight changes in prothrombin time have been noted in those adding Vinpocetine to Warfarin dosing. The changes appear minimal. There are no other interactions reported so far. Therefore, it can be applied in combinations. Commercial Pack Cerivin Tablet : Box containing 100 tablets in 10 x 10’s blister strips. Each tablet contains Vinpocetine INN 5 mg.
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Clobex® Capsule/Syrup
Description Clobex (Cloxacillin) is a beta-lactamase resistant antibacterial agent with bactericidal activity against most Gram-positive organisms and Neisseria spp. It is also effective against beta-lactamase producing Gram-negative organisms when given with Ampicillin. Indications Clobex is indicated for the treatment of infections caused by Grampositive organisms including infections caused by beta-lactamase producing Staphylococci such as : ♦ Skin and soft tissue infections : Boils, Abscesses, Carbuncles,
Furunculosis, Cellulitis, Infected wounds, Infected burns, Otitis media and externa, Protection of skin graft and Skin infections like ulcer, eczema, acne, etc. ♦ Respiratory tract infections : Pneumonia, Lung abscess, Empyema,
Sinusitis, Pharyngitis and Tonsillitis. ♦ Other infections caused by sensitive organisms : Osteomyelitis,
Enteritis, Endocarditis, Urinary tract infection, Meningitis and Septicaemia.
Dosage and Administration Adult : Usual dose is 500 mg 6 hourly daily Children (2-10 years)
: 250 mg 6 hourly daily
Children (up to 2 years)
: 125 mg (i.e. 1 measuring spoonful of Clobex Syrup) 6 hourly daily
Dose may be doubled in severe infection and should be taken at least 30 minutes before food. 103
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Contraindication Clobex should not be given to patients known to be hypersensitive to penicillin. Precautions Clobex should be given with caution to patients with known history of allergy. Side Effects Common side effects are skin rash, transient diarrhoea, nausea, heartburn, pruritus and disturbance of blood electrolyte. Rarely anaphylactic shock. Commercial Pack Clobex Capsule : Box containing 100 capsules in 10 x 10’s foil strips, each capsule containing Cloxacillin Sodium BP equivalent to 500 mg Cloxacillin. Clobex Syrup : Dry powder in glass bottle for reconstitution into 100 ml syrup. After reconstitution each 5 ml contains Cloxacillin Sodium BP equivalent to 125 mg Cloxacillin.
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Cosmotrin® Cream
Description Cosmotrin cream is a topical anti-acne preparation containing Tretinoin USP 0.025%. Each gram Cosmotrin cream contains Tretinoin USP 0.25 mg. Pharmacology Although the exact mode of action of Tretinoin is unknown, but current evidence suggests that topical Tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally Tretinoin stimulates mitotic activity and increases turnover of follicular epithelial cells, causing extrusion of the comedones, papules and pustules. Indications For topical application in the treatment of acne vulgaris in which comedones, papules and pustules predominate. Dosage and Application Cosmotrin cream should be applied sparingly to the whole affected area once or twice daily. The skin should be thoroughly cleaned and dried before application. Patient should be advised that 6 to 8 weeks of treatment may be required before a therapeutic effect is observed. Moisturisers and cosmetics may be used during treatment with Cosmotrin cream but should not be applied to the skin at the same time. Astringent toiletries should be avoided. Contraindication Tretinoin is contraindicated to those who are highly sensitive to any of the ingredients. This cream should not be used in patients with a personal or family history of cutaneous epithelioma (skin cancer). Use in Pregnancy and Lactation There is an inadequate evidence of the safety of topically applied Tretinoin cream during pregnancy. Tretinoin has been associated with teratogenicity in human when administered systemically. So, the cream should not be used during pregnancy and lactation. 105
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Side Effects Initial external application of Tretinoin generally may cause burning or slight irritation. Erythema and peeling at the site of application. If irritation becomes severe and persists, discontinue application and consult physician, if necessary. Drug Interactions Other topical acne treatments should be used with caution during treatment with Tretinoin. Particular caution should be exercised when using preparation containing a peeling agent for example benzoyl peroxide. It is also possible to apply Tretinoin and benzoyl peroxide alternately. The suggested regimens are either Tretinoin in the morning and benzoyl peroxide in the evening or the preparations should be used on alternate days. Precautions Avoid contact of Tretinoin with lips, mouth, eyes, eyelids, nostrils or other mucous membrane. If contact in these areas occur, careful washing with water is recommended. Apply the cream to sensitive areas of skin, such as the neck, with caution. Do not use it on broken, eczematous or sun burned skin. Pharmaceutical Precaution Keep out of the reach of children. Keep in a cool and dry place, protect from light. Commercial Pack Cosmotrin Cream : Tube containing 10 g cream, each gram contains Tretinoin USP 0.25 mg.
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Cox ®B Capsule
Description Cox B (Celecoxib) is a selective cyclooxygenase-2 (COX-2) inhibitor, nonsteroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Celecoxib is believed to be due to the inhibition of prostaglandin synthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. At therapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1 (COX-1) isoenzyme. Indications ♦ For the relief of the signs and symptoms of osteoarthritis. ♦ For the relief of the signs and symptoms of rheumatoid arthritis. ♦ For the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP). Dosage and Administration Osteoarthritis : The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily. Rheumatoid arthritis : The recommended oral dose is 100 to 200 mg twice daily. Familial adenomatous polyposis (FAP) : Usual medical care for FAP patients should be continued while on Cox B. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2 x 200 mg capsules) twice daily to be taken with food. Contraindication Cox B is contraindicated in patients with known hypersensitivity to Celecoxib. It should not be given to patients who have demonstrated allergic-type reactions to Sulfonamides (Celecoxib contains a sulfonamide side chain). Celecoxib should not be given to patients who have demonstrated asthma, urticaria or allergic-type reactions after taking Aspirin or other 107
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NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Adverse Reactions Adverse events occurring in ≥ 2% of patients at recommended doses- Abdominal pain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%, back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%, dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%, rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash 2.2%. The following adverse events occurred in 0.1-1.9% of patientsGeneral : Allergy aggravated, allergic reaction, asthenia, chest pain, oedema generalized, face oedema, fatigue, fever, hot flushes, influenzalike symptoms, pain, peripheral pain. Gastrointestinal : Constipation, diverticulitis, dysphagia, oesophagitis, gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids, hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting. Cardiovascular : Aggravated hypertension, angina pectoris, coronary artery disease, myocardial infarction. Nervous system : Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo. Female reproductive system : Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis. Male reproductive system : Prostatic disorder. Resistance mechanism disorders : Herpes simplex, herpes zoster, bacterial infection, fungal infection, infection of soft tissue, viral infection, moniliasis, moniliasis genital, otitis media. Hearing and vestibular : Deafness, ear abnormality, earache, tinnitus.
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Heart rate and rhythm : Palpitation, tachycardia. Respiratory : Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnoea, laryngitis, pneumonia. Liver and biliary system : Peptic function abnormal, increased AST and ALT. Musculoskeletal : Arthralgia, arthrosis, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis. Urinary system : Albuminuria, cystitis, dysuria, haematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection. Metabolic and nutritional : Blood urea nitrogen (BUN), CPK, creatinine, alkaline phosphatase, are increased. Hypercholesterolaemia, hyperglycaemia, hypokalaemia. Body weight is also increased. Psychiatric : Anorexia, anxiety, increased appetite, depression, nervousness, somnolence. Haemic : Anaemia, ecchymosis, epistaxis, thrombocythaemia. Skin and appendages : Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin, increased sweating, urticaria. Application site disorders : Cellulitis, contact dermatitis, skin nodule. Special senses : Taste perversion. Vision : Blurred vision, cataract, conjunctivitis, eye pain, glaucoma. Use in Special Population Geriatric : Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.
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Paediatric : The safety and efficacy of Celecoxib is not established in paediatric patients. Hepatic Insufficiency : Cox B capsules should be introduced at a reduced dose in patients with moderate hepatic impairment. The use of Celecoxib in patients with severe hepatic impairment is not recommended. Pregnancy : Cox B should be used during pregnancy only if the potential benefit justifies the potential risk of the foetus. In late pregnancy (third trimester), Celecoxib should be avoided because it may cause premature closure of the ductus arteriosis. Precautions Cox B, at doses up to 200 mg bid, can be administered without regard to timing of meal. Higher doses (400 mg bid) should be administered with food. Co-administration of Cox B with an aluminium and magnesiumcontaining antacid should be avoided, because they may reduce the amount of Celecoxib that the body absorbs. Drug Interactions ACE inhibitors : Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given into consideration in patients taking Cox B concomitantly with ACE inhibitors. Frusemide : NSAIDs can reduce the natriuretic effect of frusemide and thiazides in some patients. Aspirin : Cox B can be used with low dose Aspirin. However, concomitant administration of Aspirin with Cox B may result in an increased rate of gastrointestinal ulceration or similar complications, compared to the use of Cox B alone. Fluconazole : Concomitant administration of Fluconazole at 200 mg qid resulted in a two-fold increase in Celecoxib plasma concentration. Cox B should be introduced at the lowest recommended dose in patients receiving Fluconazole. Lithium : Patients on Lithium treatment should be closely monitored when Cox B is introduced or withdrawn. Warfarin : Caution should be used when administering Cox B with Warfarin since these patients are at increased risk of bleeding complications.
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Overdosage Symptoms following NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Pharmaceutical Precaution Store at temperature between 15οC and 30οC. Commercial Pack Cox B-100 Capsule : Box containing 50 capsules in 5 x 10’s blister strips. Each capsule contains Celecoxib INN 100 mg. Cox B-200 Capsule : Box containing 50 capsules in 5 x 10’s blister strips. Each capsule contains Celecoxib INN 200 mg.
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Curin ® Tablet
Description Curin tablet is a preparation of Levocetrizine Dihydrochloride. Levocetrizine is the active (levo) isomer of Cetrizine. It is a new highly effective and well-tolerated non-sedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H1-receptors than Cetirizine. Levocetirizine has a rapid and long-lasting action, allowing once-a-day administration. Indications Curin is indicated in the treatment of symptoms associated with allergic conditions such as seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria. Dosage and Administration Adults & children over 6 years of age : One Curin tablet (Levocetrizine Dihydrochloride 5 mg) once daily. Patients with renal impairment : The recommended dose in patients with moderate renal impairment is one Curin tablet every two days. In those with sever renal impairment, the dose interval should be increased to every three days. Patients with end-stage renal disease should not be given Levocetirizine. Side Effects Generally Levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely. Contraindications Curin is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients. Use in Pregnancy and Lactation: The safety of Levocetirizine in pregnancy has not been established. Therefore, it should be used with caution during pregnancy and only if the potential benefits to the mother outweigh any risks to the fetus. 112
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Levocetirizine passes into breast milk. So, it should be used with caution in nursing mothers and only if the expected benefit to the mother is greater than the positive risk to the nursing infant. Pediatric Use Not recommended for use in children less than 6 years of age. Overdosage No clinically relevant adverse events have been reported in case of overdosage. However, in the event of overdosage, symptomatic and supportive treatment is recommended. Pharmaceuticals Precautions Keep out of reach of children. Keep in a cool dry place. Commercial Pack Curin Tablet : Each box contains 10 blister strips of 10 tablets. Each film coated tablet contains Levocetrizine Dihydrochloride INN 5 mg.
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Decacycline® Capsule
Description Decacycline contains Tetracycline Hydrochloride BP. Tetracycline Hydrochloride is a broad spectrum antibiotic. It is active against a wide range of Gram-positive and Gram-negative bacteria and even some that are resistant to penicillins. It is primarily bacteriostatic in activity. Due to increasing bacterial resistance, Tetracycline use has been decreased. However, it remains the treatment of choice for infections caused by Chlamydia, Rickettsiae, Mycoplasma and Brucella. When penicillin is contraindicated, Tetracycline is an alternative drug in treatment of infections caused by Neisseria gonorrhoeae, Treponema pallidum and Treponema pertenue. Indications Decacycline is indicated in the infections caused by Tetracycline sensitive microorganisms. Respiratory tract infections: Acute and chronic bronchitis, lobar and bronchopneumonia, atypical pneumonia, lung abscess. Gastro-intestinal infections: Amoebic dysentery, bacillary dysentery, enteritis, hepatic infections, cholangitis, and cholecystitis. Genito-urinary infections: Pyelonephritis (acute and chronic), cystitis, urethritis, and epididymitis, non-gonococcal urethritis, gonorrhoea. Soft tissue infections: Mild to moderate acne, typhus fever. Other infections: Trachoma, psittacosis, whooping cough, brucellosis (in combination with other antibacterial drugs), rickettsial fevers, actinomycosis, anthrax, Rocky Mountain spotted fever etc. Dosage and Administration Adults : Usual dose is 250 mg every 6 hours and can be increased in severe infection to 500 mg every 6-8 hours. In case of primary, secondary or 114
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latent syphilis : 500 mg every 6 hours for 14-21 days. Non-gonococcal urethritis : 500 mg every 6 hours for 7-14 days. Brucellosis : 500 mg 4 times/day for 3 weeks (accompanied by other antibacterial drugs). Severe acne (long term therapy) : Initially, 1 g/day in divided doses. For maintenance 125-500 mg/day should be given. Children (over 12 years of age) : Daily dose is 10-20 mg/lb (25-50 mg/kg) in 4 equal doses. Contraindication Decacycline is contraindicated in renal impairment, during pregnancy and lactation, children under 12 years of age, systemic lupus erythematosus and hypersensitivity to any other Tetracyclines. Side Effects Gastrointestinal side effects especially nausea, vomiting and diarrhoea are most frequently reported. Glossitis, stomatitis, vaginitis or Staphylococcal enterocolitis may occur. Anaphylaxis may occur on rare occasions. Pharmaceutical Precaution Store in a cool and dry place. Keep out of the reach of children. Use in Pregnancy and Lactation Tetracycline should be avoided in pregnant women, because of the risk of both staining of teeth and effect on bone growth in the foetus. Tetracycline has been found in the breast milk of lactating mothers. There is probably negligible absorption of Tetracycline by breasted infants, because of chelation by the calcium in milk. Commercial Pack Decacycline Capsule : Box containing 10 blister strips of 10 capsule, each capsule contains Tetracycline Hydrochloride BP 250 mg.
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Decomit® Inhaler
Description The active ingredient of Decomit Inhaler (Beclomethasone Dipropionate BP) is a synthetic halogenated corticosteroid with anti-inflammatory activity. Indications Decomit Inhaler (Beclomethasone Dipropionate BP) given by inhalation has a potent anti-inflammatory action within the lungs without the side effects observed when steroids are administered systemically. Decomit inhaler is indicated for the management of patients with bronchial asthma including : ♦
Patients whose asthma is becoming worse and is inadequately controlled by bronchodilator therapy alone
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Patients whose asthma is not controlled by the combined use of bronchodilator and Sodium Cromoglycate
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Patients with severe asthma being treated with systemic corticosteroids or synthetic or actual adrenocorticotrophic hormone (ACTH)
Dosage and Administration It may take 1-3 months to achieve maximum therapeutic benefit from any corticosteroid inhalation therapy. Patients should be given a starting dose of inhaled Beclomethasone Dipropionate that is appropriate for the severity of their disease. The dose may then be adjusted until control is achieved or reduced to the minimum effective dose according to individual response. Adults : The usual recommended maintenance dose is 100-250 µg given three or four times a day. Alternatively, 200-500 µg given twice daily has been effective in some patients. In patients with severe asthma, it is advisable to start with 600 to 1000 µg a day and reduce the dose according 116
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to the response of the patients. High dose (up to 2000 µg daily) may control asthmatics not adequately controlled with more conventional doses. In patients receiving doses of 1500 µg or more, adrenal suppression (though may not be clinically significant) may occur which should be balanced against the therapeutic advantages. Children : The usual starting dose is 100 µg twice daily. Some patients may require 100 µg three to four times daily (or 200 µg twice daily). Total dose for children should not exceed 500 µg daily. Contraindication Hypersensitivity to Beclomethasone is a contraindication; and special care is necessary in patients with active or quiescent pulmonary tuberculosis. Precautions Patients should be instructed about proper use of the inhalers to ensure that the drug reaches the target areas within the lungs. They should also be made aware that Beclomethasone inhaler has to be used regularly for optimum benefit. Patients should be made aware of the prophylactic nature of therapy with Beclomethasone inhaler and that it should be taken regularly, even when they are asymptomatic. The maximum daily administration of Beclomethasone inhaler should not exceed 1 mg. Significant reduction in plasma cortisone levels has been reported in patients who receive twice this amount. Side Effects Candidiasis of the mouth and throat (thrush) occurs in some patients, the incidence of which is increased with doses greater than 400 µg Beclomethasone Dipropionate per day. Patients with high blood levels of Candida precipitins, indicating a previous infection, are most likely to develop this complication. Some patients may find it helpful to rinse their mouth thoroughly with water after using the inhaler. Symptomatic candidiasis can be treated with topical antifungal therapy whilst still continuing the Beclomethasone inhaler. In some patients, inhaled Beclomethasone Dipropionate may cause hoarseness or throat irritation. It may be helpful to rinse mouth with water immediately after inhalation. 117
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As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. Pharmaceutical Precaution Store below 30° C, keep out of the reach of children. Commercial Pack Decomit 100 Inhaler : Each canister contains 200 metered doses, each containing 100 µg of Beclomethasone Dipropionate BP. Decomit 250 Inhaler : Each canister contains 200 metered doses, each containing 250 µg of Beclomethasone Dipropionate BP.
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Decomit® Nasal Spray
Description Beclomethasone Dipropionate BP, the active ingredient of Decomit nasal spray, is an anti-inflammatory steroid having the chemical name 9-chloro11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione21dipropionate. Decomit nasal spray is a metered dose manual pump spray unit containing a microcrystalline suspension of Beclomethasone Dipropionate in a mixture of suspending agents. Indications Decomit nasal spray is indicated for the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hay fever and vasomotor rhinitis. Beclomethasone Dipropionate nasal spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal. Dosage and Administration Decomit nasal spray is for administration by the intranasal route only Adults and children : The recommended dosage is two applications into each nostril twice daily. For some patients, a dosage regimen of a single application into each nostril three or four times daily may be preferred. Total daily administration should not normally exceed eight applications. For full therapeutic benefit, regular usage is essential. The cooperation of the patient should be sought to comply with the regular dosage schedule and it should be explained that maximum effect may not be obtained within the first few applications. For children under six years, there are insufficient clinical data to recommend its use. Contraindication Decomit nasal spray is contraindicated in patients with a history of hypersensitivity to any of its components.
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Precautions Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contraindication to treatment with Decomit nasal spray. Care must be taken while transferring patients from systemic steroid treatment to Decomit nasal spray if there is any reason to suppose that their adrenal function is impaired. Systemic effects may rarely occur. These include hypothalamic-pituitaryadrenal (HPA) suppression and growth retardation in children. Although Decomit nasal spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may, in certain instances, necessitate appropriate additional therapy particularly to control eye symptoms. Side Effects As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant taste and smell and epistaxis have been reported rarely. Rare cases of raised intra-ocular pressure or glaucoma in association with intranasal formulations of Beclomethasone Dipropionate have been reported. Pharmaceutical Precaution Decomit nasal spray should be stored at a temperature below 30°C. Protect from frost and direct sunlight. Commercial Pack Decomit Nasal Spray : Each bottle contains 200 metered doses, each containing 50 µg of Beclomethasone Dipropionate BP.
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Deflux ® Tablet/Suspension/Paediatric Drops
Description Deflux (Domperidone) is a dopamine antagonist. As it does not enter the central nervous system, its effect is confined to the periphery and acts principally at the receptor in the chemoreceptor trigger zone. Indications ♦ Stimulation of gut motility in - Non-ulcer dyspepsia - Oesophageal reflux, reflux oesophagitis and gastritis - Diabetic gastroparesis - Functional dyspepsia - Speeding barium transit in follow through radiological studies ♦ Prevention and symptomatic relief of acute nausea and vomiting from
any cause including cytotoxic therapy, radiotherapy and antiparkinsonism therapy ♦ In the prophylactic treatment of migraine
Dosage and Administration The recommended oral dose for Adults: 10-20 mg every 4-8 hours daily; Children: 0.2-0.4 mg/kg every 4-8 hours daily. Note that Domperidone should be taken 15-30 minutes before meal. For acute vomiting and nausea, maximum period of treatment is 12 weeks. Use in children is restricted to nausea and vomiting following cytotoxic drugs or radiotherapy. Contraindication Deflux is contraindicated to the patients who have hypersensitivity to this drug and in case of neonates. Precautions Deflux should be used with absolute caution in case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood brain barrier. 121
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Side Effects Domperidone may produce hyperprolactinaemia (1.3% frequency). This may result in galactorrhoea, breast enlargement, soreness and reduced libido. Dry mouth (1.9%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhoea (0.2%), skin rash and itching (0.1%) may occur during treatment with Domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies. Use in Pregnancy and Lactation The safety of Domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated teratogenic effects on the foetus. Domperidone may precipitate galactorrhoea and improve post-natal lactation. It is secreted in breast milk but in very small quantities, insufficient to be considered harmful. Drug Interactions Domperidone may reduce the hypoprolactinaemic effect of bromocriptine. Anti-muscarinics and opioid analgesics may antagonize the action of Domperidone on gastrointestinal function. Overdosage There is no reported case of overdosage. Commercial Pack Deflux Tablet : Box containing 10 x 10’s blister strips. Each tablet contains Domperidone Maleate BP equivalent to 10 mg Domperidone. Deflux Suspension : Bottle containing 100 ml of suspension. Each 5 ml contains Domperidone BP 5 mg. Deflux Paediatric Drops : Bottle containing 15 ml of drops. Each ml contains Domperidone BP 5 mg.
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Dextromethorphan ® Syrup
Description Dextromethorphan Syrup is cherry flavoured liquid, containing in each 5 ml, 10 mg Dextromethorphan Hydrobromide BP. Dextromethorphan (d3-methoxy-N-methylmorphinan) is the d-isomer of the codeine analogue of levorphanol. It is a cough suppressant. Indications As antitussive. Dosage 1-3 teaspoonful 1-4 times daily or as advised by the physician. Warning Not for children use. Contraindication Liver disease. Precautions Should be administered with caution to asthmatic patient. Side Effects Occasionally Dextromethorphan hydrobromide may cause drowsiness, dizziness, excitation, mental confusion and gastrointestinal disturbance. Very high doses may produce respiratory depression. Abuses of Dextromethorphan have been reported in few cases, but there does not appear to be any evidence of dependence of the morphine type. Commercial Pack Dextromethorphan Syrup: 100 ml syrup in glass bottle, each 5 ml contains 10 mg of Dextromethorphan Hydrobromide BP.
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Diactin® Tablet
Description Diactin (Glipizide) is an oral blood glucose lowering drug of the sulfonylurea class which causes hypoglycaemia by stimulating release of insulin from pancreatic β cells and by increasing the sensitivity of peripheral tissues to insulin. Indications Diactin (Glipizide) is indicated as an adjunct to diet for the control of hyperglycaemia and its associated symptomatology in the treatment of non-insulin-dependent diabetes mellitus (NIDDM type II) when diet modification has not been proved effective on its own. In certain patients who are receiving insulin, the concurrent use of Glipizide would allow a reduction in the daily dose of insulin. Use of Glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, short term administration may be required if diet control alone results in transient control of blood glucose level. During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued. Dosage and Administration Like any other oral hypoglycaemic agent, dosage of Diactin is not fixed and may be adjusted through periodic monitoring of blood glucose level. Short term administration of Glipizide may be sufficient during periods of transient loss of control of blood glucose in patients, usually controlled well on diet. In general, Diactin should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.
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Initial dose : The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg. Dosage adjustments : Dosage adjustment may be done at intervals of several days by an increment of 2.5-5 mg, as determined by blood glucose response. If response to a single dose is not satisfactory, dividing that dose might prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate caloric content. The maximum recommended total daily dose is 40 mg. Maintenance : Some patients may be effectively controlled on a once daily regimen, while others show better response with divided dosing. Total daily dose above 30 mg have been safely given on bid basis to long-term patients. Patients can usually be stabilized on a dosage ranging from 2.5 to 30 mg daily. In elderly, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycaemic reactions. Patients Receiving Insulin : Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so. Patients receiving other oral hypoglycaemic agents : As with other sulfonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects. Contraindication Diactin is contraindicated in the following conditions : ♦
Patients who are hypersensitive to Glipizide or any component of the product
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Juvenile onset diabetes
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Severe or unstable ‘brittle’ diabetes
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Diabetes complicated by ketosis and acidosis, major surgery, severe sepsis or severe trauma
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Severe renal, hepatic or thyroid impairment, co-existent renal and hepatic disease
Precautions Hypoglycaemia : All sulfonylurea drugs are capable of producing severe hypoglycaemia. Proper patient selection, dosage and instructions are important to avoid hypoglycaemic episodes. Renal or hepatic insufficiency may cause elevated blood levels of Glipizide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycaemic actions of glucose lowering drugs. Renal and Hepatic Disease : The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted. Loss of Control on Blood Glucose : When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin. The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug. Side Effects The majority of side effects have been dose-related, transient, and responded to dose reduction or withdrawal of the medication. Hypoglycaemia : See "Precautions" and "Overdosage" section. Gastrointestinal : Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and 126
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gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs. Dermatological : Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued. Haematologic : Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulfonylureas. Metabolic : Hepatic porphyria and disulfiram like reactions have been reported with sulfonylurea. Endocrine Reactions : Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulfonylureas. Miscellaneous : Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy. Warning The administration of oral hypoglycaemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus Insulin. Although the study report was based on use of Tolbutamide only, but from a safety point of view this warning may also be applied for other oral hypoglycaemic agents. Patients should be instructed to take their meals regularly and not to exercise excessively without additional calorie intake. Overdosage Overdosage of sulfonylurea including Glipizide can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should be continued until the physician is assured that 127
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the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycaemia may recur after apparent clinical recovery. Clearance of Glipizide from plasma would be prolonged in persons with liver disease. Because of the extensive protein binding of Glipizide, dialysis is unlikely to be of benefit. Drug Interactions The hypoglycaemic action of sulfonylurea may be potentiated by certain drugs including non-steroidal anti-inflammatory agents and other drugs that are highly protein bound e.g. Salicylates, Sulfonamides, Chloramphenicol, Probenecid, Coumarins, Monoamine Oxidase Inhibitors, and β-adrenergic blocking agents. When such drugs are administered to a patient receiving Glipizide, the patients should be observed closely for hypoglycaemia. When such drugs are withdrawn from a patient receiving Glipizide, the patient should be observed closely for loss of control on blood glucose. Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide. Use in Pregnancy and Lactation Glipizide was found to be mildly foetotoxic in rat reproductive studies at all dose levels (5-50 mg/kg) like other sulfonylureas. There are no adequate and well controlled studies in pregnant women. Glipizide should
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be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Because recent information suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend to use Insulin during pregnancy to maintain blood glucose levels as close to normal as possible. Although it is not known whether Glipizide is excreted in human milk, some sulfonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication. Precautions Prolonged severe hypoglycaemia (4-10 days) has been reported in neonates born to mothers who were receiving sulfonylurea (e.g. Glipizide) at the time of delivery. So, if Glipizide is used during pregnancy, it should be discontinued at least one month before the expected delivery date. In children safety and effectiveness have not been established. Information for Patients Patients should be informed of the potential risks and advantages of Glipizide and of alternative modes of therapy. They should also be informed about the importance of adhering to dietary instructions, of a regular exercise programme, and of regular testing of urine and/or blood glucose. The risks of hypoglycaemia, its symptoms and treatment, and conditions those predispose to its development should be explained to patients and responsible family members. Primary and secondary failure should also be explained. Pharmaceutical Precaution Store below 25° C. Commercial Pack Diactin Tablet : Box containing 10 aluminium strips of 10 tablets. Each tablet contains Glipizide BP 5 mg.
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Diaglit® Tablet
Description Diaglit (Pioglitazone) is a member of the newest class of oral antidiabetic agent called thiazolidinediones. It depends on the presence of Insulin for its mechanism of action. Pioglitazone decreases Insulin resistance in the periphery and in the liver, resulting in increased Insulin-dependent glucose disposal and decreased hepatic glucose output. It also improves abnormality in lipid metabolism by activating peroxisome proliferatoractivated receptor gamma (PPAR-γ). Indications Diaglit is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type II diabetes (NIDDM). Diaglit is indicated for monotherapy and also indicated for use in combination with sulfonylurea, Metformin or Insulin when diet and exercise plus the single agent does not result in adequate glycaemic control. Dosage and Administration Diaglit can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Diaglit monotherapy may be initiated at 15 mg or 30 mg once daily dosages in patients not adequately controlled with diet and exercise alone. For patients who respond inadequately to the initial dose of Pioglitazone, the dose can be increased up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered. Maximum recommended daily dose of Diaglit should not exceed 45 mg since doses higher than 45 mg have not been studied in placebocontrolled clinical studies. Besides, no placebo-controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy. Side Effects The overall incidence and types of adverse events reported in placebo controlled clinical trials of Pioglitazone monotherapy at doses of 7.5 mg, 130
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15 mg, 30 mg or 45 mg once daily are upper respiratory tract infection (13.2%), headache (9.1%), sinusitis (6.3%), myalgia (5.4%), tooth disorder (5.3%), and pharyngitis (5.1%). Precautions Pioglitazone exerts its antihyperglycaemic effect only in the presence of Insulin. Therefore, it should not be used in Type-1 diabetes or for the treatment of diabetic ketoacidosis. Pioglitazone should be used with caution in case of combination antidiabetic therapy and hepatic insufficiency. Liver enzyme should be monitored regularly. Use in Pregnancy and Lactation There are no adequate and well controlled studies in pregnant women. Pioglitazone should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. It is not known whether Pioglitazone is secreted in human milk. As many drugs are excreted in human milk, it should not be administered to a lactating women. Contraindication Diaglit is contraindicated in patients with known hypersensitivity to any of its components. Drug Interactions Administration of thiazolidinediones with an oral contraceptive containing ethinyl estradiol and norethindrone reduces the plasma concentration of both hormones by approximately 30% which could result in loss of contraception. Overdosage In the event of overdosage, appropriate supportive treatment should be initiated according to patient’s clinical signs and symptoms. Pharmaceutical Precaution Store at 25o C. Keep in a cool and dry place, away from direct sunlight. Keep out of the reach of children.
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Commercial Pack Diaglit 15 Tablet : Box containing 30 tablets in 3 x 10’s blister strips, each tablet contains Pioglitazone Hydrochloride INN equivalent to Pioglitazone 15 mg. Diaglit 30 Tablet : Box containing 30 tablets in 3 x 10’s blister strips, each tablet contains Pioglitazone Hydrochloride INN equivalent to Pioglitazone 30 mg.
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Diapro ® Tablet
Description Diapro (Gliclazide) is a second generation sulfonylurea that has hypoglycaemic and potentially useful haemobiological properties. It stimulates the influx of calcium ions into pancreatic β cells and as a result increases Insulin secretion. Moreover, in vivo studies have demonstrated changes in thrombin-induced platelet aggregation in NIDDM patients treated with gliclazide. Indications Non-insulin dependent diabetes mellitus (type-II) when dietary modification has failed. Dosage and Administration Initially 40-80 mg daily, adjusted according to response; up to 160 mg as a single dose, with breakfast; higher doses divided; maximum 320 mg daily. Adverse Reactions Potentially life-threatening effects- All hypoglycaemic agents have the potential to cause severe hypoglycaemia and may cause severe brain damage or death. Gliclazide used in standard dose is less likely than Glyburide to cause hypoglycaemia. Hypoglycaemia may be favoured by concurrent conditions such as hepatic and renal disease, malnutrition, anorexia, senility, alcohol intoxication or adrenal and pituitary insufficiency. Severe or irreversible adverse effects- Approximately 2% of patients have been withdrawn from therapy because of adverse reactions, namely hypoglycaemia (overdose effect), gastrointestinal disturbances and dermatological reactions. Symptomatic adverse effects- Headache, gastrointestinal upsets, nausea and dizziness have been reported and skin reactions, including rash,
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pruritus, erythema and bullous eruptions may occur. Abnormalities of liver function are not uncommon. High Risk Group ♦ Neonates- The drug is not used in neonates. ♦ Nursing mothers- The drug should not be used by lactating mothers. ♦ Children- Gliclazide is contraindicated in children. ♦ Pregnant women- Gliclazide, as other sulfonylurea, is contraindicated for use in pregnant women. No teratogenic changes have been found in animals or human, but diabetes can be controlled more effectively in pregnancy by Insulin than by oral hypoglycaemic agents. ♦ Elderly- All sulfonylureas should be used with caution in the elderly because of the greater likelihood of their missing meals and the more severe outcome of significant hypoglycaemia. ♦ Concurrent disease- Definite hepatic disease should contraindicate the use of Gliclazide, since it is almost completely metabolized in the liver. Renal disease does not appear significantly to alter the pharmacokinetics, although it may be wise to limit the maximum dose when serum creatinine starts to rise. Drug Interactions Potentially hazardous interactions- These may be divided into those which will tend to increase the hypoglycaemic effect and those tending to oppose it. In the first category come drugs which displace the sulfonylurea from protein binding, such as Aspirin, non-steroidal antiinflammatory drugs, Phenylbutazone, Clofibrate, Sulfonamides and Coumarin anticoagulants; or which inhibit, hepatic microsomal enzymes, for example Cimetidine, sulfonamides, imidazole antifungal agents and the Monoamine Oxidase Inhibitors (MAOI), which may increase the hypoglycaemic effect of Gliclazide. Any effects, which result from protein-binding displacement, are transient, lasting from 12-24 h. Regular concomitant doses of these agents together with a constant dose of Gliclazide would not cause problems. The hypoglycaemic action of sulfonylureas may be opposed by the induction of hepatic enzymes, which metabolize the drug causing lower plasma concentrations and less hypoglycaemic effect. Common inducers include Rifampicin, barbiturates, Phenytoin and alcohol, or by drugs that 134
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inhibit the release or action of Insulin, e.g. thiazide diuretics, dizoxide, glucocorticoids, oestrogens or sympathomimetic drugs. Early symptoms of hypoglycaemia such as tremor, sweating and tachycardia may be masked by β-adrenoreceptor blocking drugs, such as Propranolol allowing severe hypoglycaemic episodes without preceding warning symptoms. If β-adrenoreceptor blocking drugs are required the more selective types, such as Metoprolol or Atenolol, are preferred in the diabetic patient. Pharmaceutical Precaution Store below 250 C. Commercial Pack Diapro Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Each tablet contains Gliclazide BP 80 mg.
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Diaryl® Tablet
Description Diaryl (Glimepiride) tablets are an oral blood-glucose-lowering drug of the sulfonylurea class. Chemically, glimepiride is identified as 1-[[p-[2-(3ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]3-(trans-4-methylcyclohexyl) urea. Pharmacology The primary mechanism of action of Glimepiride is lowering of blood glucose by stimulating the release of insulin from functioning pancreatic β cells. In addition, extra-pancreatic effects may also play vital role in the activity of Glimepiride. Administration of Diaryl can lead to increase sensitivity of peripheral tissues to insulin. After oral administration. Glimepiride is completely (100%) absorbed from gastrointestinal tract. When Glimepiride is given with meals, the mean T max is slightly increased (12%) and the mean Cmax and AUC are slightly decreased. Glimepiride is completely metabolized by oxidative biotransformation after oral dose. When 14 C-Glimepride is given orally, approximately 60% of the total radioactivity is recovered in the urine in 7 days and 80-90% of the metabolites are recovered in the urine. Indications Non-insulin dependent (type-III) diabetes, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction. Diaryl is also indicated for use in combination with Insulin to lower blood glucose in patients whose hyperglycaemia can not be controlled by diet and exercise or in conjunction with an oral hypoglycaemic agent. Dosage and Administration In principle, the dosage of Diaryl is governed by the desired blood sugar level. The dosage of Diaryl must be the lowest which is sufficient to achieve the desired metabolic control.
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The initial and the maintenance doses are set based on the results of regular checking of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy. Initial dose and dose titration : Usual initial dose is 1 mg once daily. If necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of one to two weeks and carried out stepwise at follows: 1 mg-2 mg-3 mg-4 mg-6 mg. Dose range in patients with well controlled diabetes: Usual dose range in patients with well controlled diabetes is 1 to 4 mg daily. Distribution of doses : Timing and distribution of doses are decided by the physician, in consideration of the patient's current life style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or - if none is taken - immediately before the first main meals. It is very important not to skip meals after taking the drug. Secondary dosage adjustment : As the control of diabetes improves, sensitivity to insulin increases; therefore, Diaryl requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life style changes, or other factors arise which cause an increased susceptibility to hypo- or hyperglycaemia. Changeover from other oral antidiabetics to Diaryl : There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from the maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in initial dose and dose titration.
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Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia. Administration : Diaryl tablet must be swallowed without chewing and with sufficient amount of liquid (approximately ½ glass). Contraindication Glimepiride is not suitable for the treatment of insulin dependent (typeI) diabetes mellitus, or of diabetic pre-coma or coma. Glimepiride must not be used in patients hypersensitive to Glimepiride or other sulphonylureas. Precautions In the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk is present it may be necessary to adjust the dosage of Glimepiride. Hypoglycaemia can almost always be promptly controlled by immediate intake of carbohydrates (glucose or sugar, e.g. sugar sweetened fruit juice or sugar sweetened tea). Side Effects Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure. Drug Interactions Potentiation of the blood-sugar-lowering effect may occur with Insulin and other oral anti-diabetics, ACE inhibitors, Allopurinol, anabolic steroids and male sex hormones, Chloramphenicol, coumarin derivatives, Fluoxetine, MAO inhibitors, Miconazole, Para-aminosalicyclic acid, Pentoxifylline (high dose parenteral), Phenylbutazone, Oxyphenbutazone, quinolones, salicylates, Sulfonamides, tetracyclines, β blockers. Weakening of the blood-sugar-lowering effect may occur with Acetazolamide, barbiturates, corticosteroids, Diazoxide, diuretics, Epinephrine and other sympathomimetic agents, laxative, oestrogens and progestogens, phenothiazines, Phenytoin, Rifampicin, and thyroid hormones. 138
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H 2 -receptor antagonists, Clonidine and Reserpine may lead to either potentiation or weakening of the blood-sugar-lowering effect. Both acute and chronic alcohol intake may potentiate or weaken the blood-sugar-lowering action of Glimepiride unpredictably. Use in Pregnancy and Lactation Glimepiride must not be taken during pregnancy; a changeover to Insulin is necessary. Patients planning a pregnancy must inform their physician, and should changeover to Insulin. Ingestion of Glimepiride with breast milk may harm the child. Therefore, Glimepiride must not be taken by lactating women. Either a changeover or a complete discontinuation of breast-feeding is necessary. Commercial Pack Diaryl 1 Tablet : Each box contains 3 x 10’s tablets in blister strips. Each tablet contains Glimepiride INN 1 mg. Diaryl 2 Tablet : Each box contains 3 x 10’s tablets in blister strips. Each tablet contains Glimepiride INN 2 mg. Diaryl 1 Tablet : Each tablet contains Glimepiride INN 1 mg. Diaryl 2: Each tablet contains Glimepiride INN 2 mg
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Diavix® Tablet
Description Diavix Tablets are combination tablets containing Lamivudine INN 150 mg and Zidovudine USP 300 mg. Indications Diavix is indicated for the treatment of HIV infection. Dosage and Administration The recommended oral dose of Diavix for adults and adolescents (at least 12 years of age) is one tablet (containing 150 mg of Lamivudine and 300 mg of Zidovudine) twice daily. Dose Adjustment : As it is a fixed-dose combination, Diavix should not be prescribed for patients requiring dosage adjustment such as those with reduced renal function (creatinine clearance
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