Betasef may be available in the countries listed below.
Ingredient matches for Betasef
Cefradine
Cefradine is reported as an ingredient of Betasef in the following countries:
- Bangladesh
International Drug Name Search
Thursday, October 27, 2016
Carbamazepina La Santé
Carbamazepina La Santé may be available in the countries listed below.
Ingredient matches for Carbamazepina La Santé
Carbamazepine
Carbamazepine is reported as an ingredient of Carbamazepina La Santé in the following countries:
- Colombia
International Drug Name Search
Pepticure
Pepticure may be available in the countries listed below.
Ingredient matches for Pepticure
Ranitidine
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Pepticure in the following countries:
- Sri Lanka
International Drug Name Search
Garmastan
Garmastan may be available in the countries listed below.
Ingredient matches for Garmastan
Guaiazulene
Guaiazulene is reported as an ingredient of Garmastan in the following countries:
- Turkey
International Drug Name Search
Euflex
Euflex may be available in the countries listed below.
Ingredient matches for Euflex
Flutamide
Flutamide is reported as an ingredient of Euflex in the following countries:
- Canada
International Drug Name Search
Wednesday, October 26, 2016
Effacné
Effacné may be available in the countries listed below.
Ingredient matches for Effacné
Benzoyl Peroxide
Benzoyl Peroxide hydrous (a derivative of Benzoyl Peroxide) is reported as an ingredient of Effacné in the following countries:
- France
International Drug Name Search
PPSB HT
PPSB HT may be available in the countries listed below.
Ingredient matches for PPSB HT
Prothrombin Complex, human
Prothrombin Complex, human is reported as an ingredient of PPSB HT in the following countries:
- Japan
International Drug Name Search
Fluxarten
Fluxarten may be available in the countries listed below.
Ingredient matches for Fluxarten
Flunarizine
Flunarizine dihydrochloride (a derivative of Flunarizine) is reported as an ingredient of Fluxarten in the following countries:
- Italy
International Drug Name Search
Ketmax
Ketmax may be available in the countries listed below.
Ingredient matches for Ketmax
Levamisole
Levamisole is reported as an ingredient of Ketmax in the following countries:
- Ethiopia
International Drug Name Search
Tuesday, October 25, 2016
Modafinil-Teva
Modafinil-Teva may be available in the countries listed below.
Ingredient matches for Modafinil-Teva
Modafinil
Modafinil is reported as an ingredient of Modafinil-Teva in the following countries:
- Slovakia
International Drug Name Search
Lomont
Lomont may be available in the countries listed below.
UK matches:
- Lomont 70mg/5ml Oral Suspension
- Lomont 70mg/5ml Oral Suspension (SPC)
Ingredient matches for Lomont
Lofepramine
Lofepramine hydrochloride (a derivative of Lofepramine) is reported as an ingredient of Lomont in the following countries:
- United Kingdom
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Pirbuterol Acetate
Pirbuterol Acetate may be available in the countries listed below.
Ingredient matches for Pirbuterol Acetate
Pirbuterol
Pirbuterol Acetate (BANM, USAN) is known as Pirbuterol in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Risperidon TAD
Risperidon TAD may be available in the countries listed below.
Ingredient matches for Risperidon TAD
Risperidone
Risperidone is reported as an ingredient of Risperidon TAD in the following countries:
- Germany
- Poland
International Drug Name Search
Ekzemsalbe F-Agepha
Ekzemsalbe F-Agepha may be available in the countries listed below.
Ingredient matches for Ekzemsalbe F-Agepha
Hydrocortisone
Hydrocortisone 21-acetate (a derivative of Hydrocortisone) is reported as an ingredient of Ekzemsalbe F-Agepha in the following countries:
- Austria
International Drug Name Search
Isomon
Isomon may be available in the countries listed below.
Ingredient matches for Isomon
Isosorbide Mononitrate
Isosorbide Mononitrate is reported as an ingredient of Isomon in the following countries:
- Greece
International Drug Name Search
Pustix Duo
Pustix Duo may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Pustix Duo
Permethrin
Permethrin is reported as an ingredient of Pustix Duo in the following countries:
- France
Pyriproxyfen
Pyriproxyfen is reported as an ingredient of Pustix Duo in the following countries:
- France
International Drug Name Search
Pirimetamina
Pirimetamina may be available in the countries listed below.
Ingredient matches for Pirimetamina
Pyrimethamine
Pirimetamina (DCIT) is known as Pyrimethamine in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Click for further information on drug naming conventions and International Nonproprietary Names.
Monday, October 24, 2016
Bronchotussine
Bronchotussine may be available in the countries listed below.
Ingredient matches for Bronchotussine
Bromhexine
Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Bronchotussine in the following countries:
- Greece
- Malta
International Drug Name Search
Cefazolin Pharabaco
Cefazolin Pharabaco may be available in the countries listed below.
Ingredient matches for Cefazolin Pharabaco
Cefazolin
Cefazolin is reported as an ingredient of Cefazolin Pharabaco in the following countries:
- Vietnam
International Drug Name Search
Carvedilol Bexal
Carvedilol Bexal may be available in the countries listed below.
Ingredient matches for Carvedilol Bexal
Carvedilol
Carvedilol is reported as an ingredient of Carvedilol Bexal in the following countries:
- Spain
International Drug Name Search
Controlip
Controlip may be available in the countries listed below.
Ingredient matches for Controlip
Fenofibrate
Fenofibrate is reported as an ingredient of Controlip in the following countries:
- Costa Rica
- El Salvador
- Guatemala
- Honduras
- Mexico
- Nicaragua
- Panama
International Drug Name Search
Allopurinol-Glaxo Wellcome
Allopurinol-Glaxo Wellcome may be available in the countries listed below.
Ingredient matches for Allopurinol-Glaxo Wellcome
Allopurinol
Allopurinol is reported as an ingredient of Allopurinol-Glaxo Wellcome in the following countries:
- Luxembourg
International Drug Name Search
Mopen
Mopen may be available in the countries listed below.
Ingredient matches for Mopen
Amoxicillin
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Mopen in the following countries:
- Costa Rica
- Dominican Republic
- El Salvador
- Guatemala
- Honduras
- Italy
- Nicaragua
- Panama
Mebendazole
Mebendazole is reported as an ingredient of Mopen in the following countries:
- Ethiopia
International Drug Name Search
Tacidine
Tacidine may be available in the countries listed below.
Ingredient matches for Tacidine
Nizatidine
Nizatidine is reported as an ingredient of Tacidine in the following countries:
- Australia
International Drug Name Search
Sunday, October 23, 2016
Tramtor
Tramtor may be available in the countries listed below.
Ingredient matches for Tramtor
Tramadol
Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Tramtor in the following countries:
- Taiwan
International Drug Name Search
Isedipeal
Isedipeal may be available in the countries listed below.
Ingredient matches for Isedipeal
Nicardipine
Nicardipine hydrochloride (a derivative of Nicardipine) is reported as an ingredient of Isedipeal in the following countries:
- Japan
International Drug Name Search
Mundisal
Mundisal may be available in the countries listed below.
Ingredient matches for Mundisal
Cetalkonium Chloride
Cetalkonium Chloride is reported as an ingredient of Mundisal in the following countries:
- Greece
Choline Salicylate
Choline Salicylate is reported as an ingredient of Mundisal in the following countries:
- Austria
- Czech Republic
- Greece
- Latvia
- Lithuania
- Slovakia
- Switzerland
- Taiwan
International Drug Name Search
Elcal Forte
Elcal Forte may be available in the countries listed below.
Ingredient matches for Elcal Forte
Calcium Carbonate
Calcium Carbonate is reported as an ingredient of Elcal Forte in the following countries:
- Chile
International Drug Name Search
Lansoprazol Helvepharm
Lansoprazol Helvepharm may be available in the countries listed below.
Ingredient matches for Lansoprazol Helvepharm
Lansoprazole
Lansoprazole is reported as an ingredient of Lansoprazol Helvepharm in the following countries:
- Switzerland
International Drug Name Search
Saturday, October 22, 2016
Toldex
Toldex may be available in the countries listed below.
Ingredient matches for Toldex
Aspirin
Acetylsalicylic Acid is reported as an ingredient of Toldex in the following countries:
- Portugal
International Drug Name Search
Bioginal
Bioginal may be available in the countries listed below.
Ingredient matches for Bioginal
Ciclopirox
Ciclopirox olamine (a derivative of Ciclopirox) is reported as an ingredient of Bioginal in the following countries:
- Italy
International Drug Name Search
Auxxil
Auxxil may be available in the countries listed below.
Ingredient matches for Auxxil
Levofloxacin
Levofloxacin is reported as an ingredient of Auxxil in the following countries:
- Chile
International Drug Name Search
Friday, October 21, 2016
L-Cysteine Domesco
L-Cysteine Domesco may be available in the countries listed below.
Ingredient matches for L-Cysteine Domesco
Cysteine
Cysteine is reported as an ingredient of L-Cysteine Domesco in the following countries:
- Vietnam
International Drug Name Search
Cabest
Cabest may be available in the countries listed below.
Ingredient matches for Cabest
Cabergoline
Cabergoline is reported as an ingredient of Cabest in the following countries:
- Slovakia
International Drug Name Search
Thursday, October 20, 2016
Kanis
Kanis may be available in the countries listed below.
Ingredient matches for Kanis
Clotrimazole
Clotrimazole is reported as an ingredient of Kanis in the following countries:
- Bangladesh
International Drug Name Search
Loratadina Alter
Loratadina Alter may be available in the countries listed below.
Ingredient matches for Loratadina Alter
Loratadine
Loratadine is reported as an ingredient of Loratadina Alter in the following countries:
- Portugal
International Drug Name Search
Artridol
Artridol may be available in the countries listed below.
Ingredient matches for Artridol
Glucosamine
Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Artridol in the following countries:
- Chile
International Drug Name Search
Bétahistine Zydus
Bétahistine Zydus may be available in the countries listed below.
Ingredient matches for Bétahistine Zydus
Betahistine
Betahistine dihydrochloride (a derivative of Betahistine) is reported as an ingredient of Bétahistine Zydus in the following countries:
- France
International Drug Name Search
Pelastin
Pelastin may be available in the countries listed below.
Ingredient matches for Pelastin
Cilastatin
Cilastatin is reported as an ingredient of Pelastin in the following countries:
- Indonesia
Imipenem
Imipenem is reported as an ingredient of Pelastin in the following countries:
- Indonesia
International Drug Name Search
Wednesday, October 19, 2016
Cintigo
Cintigo may be available in the countries listed below.
Ingredient matches for Cintigo
Cinnarizine
Cinnarizine is reported as an ingredient of Cintigo in the following countries:
- India
International Drug Name Search
Enalapril accedo
Enalapril accedo may be available in the countries listed below.
Ingredient matches for Enalapril accedo
Enalapril
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enalapril accedo in the following countries:
- Germany
International Drug Name Search
Clavigrenin
Clavigrenin may be available in the countries listed below.
Ingredient matches for Clavigrenin
Dihydroergotamine
Dihydroergotamine mesilate (a derivative of Dihydroergotamine) is reported as an ingredient of Clavigrenin in the following countries:
- Czech Republic
International Drug Name Search
Tuesday, October 18, 2016
Banan
Banan may be available in the countries listed below.
Ingredient matches for Banan
Cefpodoxime
Cefpodoxime proxetil (a derivative of Cefpodoxime) is reported as an ingredient of Banan in the following countries:
- China
- Hong Kong
- Japan
International Drug Name Search
Romerol
Romerol may be available in the countries listed below.
Ingredient matches for Romerol
Rosiglitazone
Rosiglitazone is reported as an ingredient of Romerol in the following countries:
- Bangladesh
International Drug Name Search
Lumix
Lumix may be available in the countries listed below.
Ingredient matches for Lumix
Sildenafil
Sildenafil citrate (a derivative of Sildenafil) is reported as an ingredient of Lumix in the following countries:
- Argentina
International Drug Name Search
Beriate P
In the US, Beriate P is a member of the drug class miscellaneous coagulation modifiers and is used to treat Hemophilia A.
Ingredient matches for Beriate P
Coagulation Factor VIII, Human
Coagulation Factor VIII, Human is reported as an ingredient of Beriate P in the following countries:
- Hungary
- Spain
- Taiwan
International Drug Name Search
Piretanid Hexal
Piretanid Hexal may be available in the countries listed below.
Ingredient matches for Piretanid Hexal
Piretanide
Piretanide is reported as an ingredient of Piretanid Hexal in the following countries:
- Germany
International Drug Name Search
Azathioprine
In some countries, this medicine may only be approved for veterinary use.
In the US, Azathioprine (azathioprine systemic) is a member of the following drug classes: antirheumatics, other immunosuppressants and is used to treat Atopic Dermatitis, Biliary Cirrhosis, Bullous Pemphigoid, Chronic Active Hepatitis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Cogan's Syndrome, Crohn's Disease - Acute, Crohn's Disease - Maintenance, Dermatomyositis, Eczema, Glomerulonephritis, Idiopathic Thrombocytopenic Purpura, Multiple Sclerosis, Myasthenia Gravis, Myopathy, Nephrotic Syndrome, Neurosarcoidosis, Organ Transplant - Rejection Prophylaxis, Pemphigoid, Pemphigus, Renal Transplant, Rheumatoid Arthritis, Sarcoidosis, Systemic Lupus Erythematosus, Takayasu's Arteritis, Ulcerative Colitis and Uveitis.
US matches:
- Azathioprine
- Azathioprine Oral, Intravenous
- Azathioprine Sodium
- Azathioprine Injection
Scheme
Rec.INN
ATC (Anatomical Therapeutic Chemical Classification)
L04AX01
CAS registry number (Chemical Abstracts Service)
0000446-86-6
Chemical Formula
C9-H7-N7-O2-S
Molecular Weight
277
Therapeutic Categories
Immunosuppressant
Disease-modifying antirheumatic drug, DMARD
Chemical Name
1H-Purine, 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-
Foreign Names
- Azathioprinum (Latin)
- Azathioprin (German)
- Azathioprine (French)
- Azatioprina (Spanish)
Generic Names
- Azathioprine (OS: BAN, DCF, USAN)
- Azatioprina (OS: DCIT)
- BW 57-322 (IS)
- NSC-39084 (IS)
- Azathioprin (PH: Ph. Eur. 6)
- Azathioprine (PH: BP 2010, Ph. Eur. 6, Ph. Int. 4, USP 32, JP XV)
- Azathioprinum (PH: Ph. Int. 4, Ph. Eur. 6)
- Azathioprine Sodium (PH: USP 32)
Brand Names
- Apo-Azathioprine
Apotex, Canada - Azafalk
Falk, Germany - Azafor
Sofar, Italy - Azahexal
Sandoz, Australia - Azaimun
Dermapharm, Switzerland; Mibe, Germany - Azamedac
Medac, Germany - Azamun
Douglas, New Zealand; Genepharm, Australia; Leiras, Finland; Pharmaplan, South Africa - Azanin
Tanabe Mitsubishi, Japan - Azapin
Sigma, Australia - Azapress
Bodene, South Africa - Azaprin
Kuwait Saudi Pharmaceutical Industries Co. - KSPICO, Oman; Nolver, Venezuela - Azaprine
Ivax, Czech Republic - Aza-Q
Juta, Germany; Q-Pharm, Germany - Azarek
Hexal, Luxembourg; Sandoz, Switzerland - Azarekhexal
Hexal, Estonia; Hexal, Lithuania - Azasan
AAI, United States; Salix, United States - Azathioprin acis
Acis, Germany - Azathioprin Actavis
Actavis, Denmark; Actavis, Sweden - Azathioprin AL
Aliud, Germany - Azathioprin Arrow
Arrow Generics Ltd.GB, Denmark - Azathioprin AWD
AWD.pharma, Germany - Azathioprin beta
Betapharm, Germany - Azathioprin Copyfarm
Copyfarm, Denmark; Orifarm, Sweden - Azathioprin dura
Mylan dura, Germany - Azathioprin Heumann
Heumann, Germany - Azathioprin Hexal
Hexal, Austria; Hexal, Germany - Azathioprin medac
Medac, Germany - Azathioprin Sandoz
Sandoz, Germany; Sandoz, Netherlands - Azathioprin Stada
Stada, Germany - Azathioprin Teva
Teva, Germany - Azathioprin-1A Pharma
1A Pharma, Germany - Azathioprina Carrion
Carrion, Peru - Azathioprine A
Apothecon, Netherlands - Azathioprine Actavis
Actavis, Netherlands - Azathioprine Apotex
Apotex Europe, Netherlands - Azathioprine Cf
Centrafarm, Netherlands - Azathioprine Combiphar
Combiphar, Indonesia - Azathioprine EG
EG Labo, France - Azathioprine Merck
Mylan, Netherlands - Azathioprine Mylan
Mylan, Belgium; Mylan, France - Azathioprine PCH
Med, Turkey; Pharmachemie, Netherlands; Pharmachemie, Taiwan - Azathioprine Pharmachemie
Pharmachemie, Indonesia - Azathioprine Ratiopharm
ratiopharm, Netherlands - Azathioprine Sandoz
Sandoz, Belgium - Azathioprine Teva
Teva Santé, France - Azathioprine
Atafarm, Turkey; Betapharm, Netherlands; Chemipharm, Greece; Generics, Malta; Genpharm, United States; Hexal, Netherlands; Pharmachemie, Malaysia; Roxane, United States; Sandoz, United States; Teva, Bulgaria; Vis, Poland; Zydus, United States - Azathioprin-Puren
Actavis, Germany - Azathioprin-ratiopharm
Ratiopharm, Germany; Ratiopharm, Denmark - Azatioprin Mylan
Mylan, Sweden - Azatioprina Asofarma
Raffo, Argentina - Azatioprina Carrion
Carrion, Peru - Azatioprina Dosa
Dosa, Argentina - Azatioprina Filaxis
Filaxis, Argentina - Azatioprina Hexal
Hexal, Italy - Azatioprina Rontag
Rontag, Argentina - Azatioprina Tuteur
Teva, Argentina - Azatioprina Wellcome
GlaxoSmithKline, Italy - Azatioprina
Bestpharma, Chile; Carrion, Peru; Tecnofarma, Chile; Tecnofarma, Colombia - Azatrilem
Lemery, Mexico - Azopi
Generics, Israel - Azoran
RPG, India - Colinsan
Ferring, Germany - Gen-Azathioprine
Genpharm, Canada - GenRX Azathioprine
Apotex, Australia - Immunoprin
Ebewe, Austria; Ebewe, Italy - Imuger
Gerard, Ireland - Imuprin
Remedica, Cyprus; Remedica, Ghana; Remedica, Kenya; Remedica, Malta; Remedica, Taiwan; Remedica, Tanzania - Imuran
EU-Pharma, Netherlands; Excella, Bulgaria; GlaxoSmithKline, United Arab Emirates; GlaxoSmithKline, Argentina; GlaxoSmithKline, Australia; GlaxoSmithKline, Bosnia & Herzegowina; GlaxoSmithKline, Bangladesh; GlaxoSmithKline, Belgium; GlaxoSmithKline, Bahrain; GlaxoSmithKline, Brazil; GlaxoSmithKline, Canada; GlaxoSmithKline, Chile; GlaxoSmithKline, China; GlaxoSmithKline, Czech Republic; GlaxoSmithKline, Ecuador; GlaxoSmithKline, Estonia; GlaxoSmithKline, Ethiopia; GlaxoSmithKline, United Kingdom; GlaxoSmithKline, Georgia; GlaxoSmithKline, Guyana; GlaxoSmithKline, Hong Kong; GlaxoSmithKline, Croatia (Hrvatska); GlaxoSmithKline, Hungary; GlaxoSmithKline, Indonesia; GlaxoSmithKline, Ireland; GlaxoSmithKline, Israel; GlaxoSmithKline, India; GlaxoSmithKline, Iran; GlaxoSmithKline, Japan; GlaxoSmithKline, Kuwait; GlaxoSmithKline, Lithuania; GlaxoSmithKline, Luxembourg; GlaxoSmithKline, Latvia; GlaxoSmithKline, Mexico; GlaxoSmithKline, Malaysia; GlaxoSmithKline, Netherlands; GlaxoSmithKline, New Zealand; GlaxoSmithKline, Oman; GlaxoSmithKline, Philippines; GlaxoSmithKline, Poland; GlaxoSmithKline, Portugal; GlaxoSmithKline, Qatar; GlaxoSmithKline, Romania; GlaxoSmithKline, Serbia; GlaxoSmithKline, Singapore; GlaxoSmithKline, Slovenia; GlaxoSmithKline, Thailand; GlaxoSmithKline, Turkey; GlaxoSmithKline, Taiwan; GlaxoSmithKline, South Africa; Medcor, Netherlands; Prometheus, United States - Imuran (veterinary use)
GlaxoSmithKline, United Kingdom - Imurek
Eurim, Austria; GlaxoSmithKline, Austria; GlaxoSmithKline, Germany; Pro Concepta Zug, Switzerland - Imurel
GlaxoSmithKline, Denmark; GlaxoSmithKline, Finland; GlaxoSmithKline, France; GlaxoSmithKline, Iceland; GlaxoSmithKline, Norway; GlaxoSmithKline, Sweden; GlaxoSmithKline, Tunisia; UCB, Spain - Thioprine
Alphapharm, Australia - Transimune
Troikaa, India - Zaprine
Sandoz, South Africa - Zytrim
Merckle Recordati, Germany - Azathioprine PCH
Pharmachemie, Netherlands - Azathioprine Sodium
Bedford, United States - Azathioprine
Pharmachemie, Sri Lanka - Imuran
GlaxoSmithKline, Canada; GlaxoSmithKline, Ireland; GlaxoSmithKline, Netherlands; GlaxoSmithKline, New Zealand; Prometheus, United States - Imurek
GlaxoSmithKline, Germany; Pro Concepta Zug, Switzerland
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Acyl
Acyl may be available in the countries listed below.
Ingredient matches for Acyl
Acyclovir
Aciclovir is reported as an ingredient of Acyl in the following countries:
- Ethiopia
- Turkey
International Drug Name Search
Alimémazine
Alimémazine may be available in the countries listed below.
Ingredient matches for Alimémazine
Alimemazine
Alimémazine (DCF) is also known as Alimemazine (Rec.INN)
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Monday, October 17, 2016
Cétirizine
Cétirizine may be available in the countries listed below.
Ingredient matches for Cétirizine
Cetirizine
Cétirizine (DCF) is known as Cetirizine in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Click for further information on drug naming conventions and International Nonproprietary Names.
Prilace
Prilace may be available in the countries listed below.
Ingredient matches for Prilace
Enalapril
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Prilace in the following countries:
- Ecuador
- Venezuela
Piretanide
Piretanide is reported as an ingredient of Prilace in the following countries:
- Italy
Ramipril
Ramipril is reported as an ingredient of Prilace in the following countries:
- Australia
- Italy
International Drug Name Search
Acemycin
Acemycin may be available in the countries listed below.
Ingredient matches for Acemycin
Cefamandole
Cefamandole nafate (a derivative of Cefamandole) is reported as an ingredient of Acemycin in the following countries:
- Greece
International Drug Name Search
Molsidomin Sandoz
Molsidomin Sandoz may be available in the countries listed below.
Ingredient matches for Molsidomin Sandoz
Molsidomine
Molsidomine is reported as an ingredient of Molsidomin Sandoz in the following countries:
- Germany
International Drug Name Search
Metoclopramide Actavis
Metoclopramide Actavis may be available in the countries listed below.
Ingredient matches for Metoclopramide Actavis
Metoclopramide
Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Metoclopramide Actavis in the following countries:
- Estonia
- Netherlands
International Drug Name Search
Tétrazépam G Gam
Tétrazépam G Gam may be available in the countries listed below.
Ingredient matches for Tétrazépam G Gam
Tetrazepam
Tetrazepam is reported as an ingredient of Tétrazépam G Gam in the following countries:
- France
International Drug Name Search
Sunday, October 16, 2016
Bioferro
Bioferro may be available in the countries listed below.
Ingredient matches for Bioferro
Ferrous Gluconate
Ferrous Gluconate is reported as an ingredient of Bioferro in the following countries:
- Portugal
International Drug Name Search
Aldoril
In the US, Aldoril (hydrochlorothiazide/methyldopa systemic) is a member of the drug class antihypertensive combinations and is used to treat High Blood Pressure.
US matches:
- Aldoril
- Aldoril 15
- Aldoril 25
- Aldoril D30
- Aldoril D50
Ingredient matches for Aldoril
Hydrochlorothiazide
Hydrochlorothiazide is reported as an ingredient of Aldoril in the following countries:
- United States
Methyldopa
Methyldopa is reported as an ingredient of Aldoril in the following countries:
- United States
International Drug Name Search
Anginin
Anginin may be available in the countries listed below.
Ingredient matches for Anginin
Pyricarbate
Pyricarbate is reported as an ingredient of Anginin in the following countries:
- Israel
- Japan
International Drug Name Search
Saturday, October 15, 2016
Atenix
Atenix may be available in the countries listed below.
Ingredient matches for Atenix
Sertraline
Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Atenix in the following countries:
- Argentina
Sibutramine
Sibutramine is reported as an ingredient of Atenix in the following countries:
- Ecuador
Sibutramine hydrochloride monohydrate (a derivative of Sibutramine) is reported as an ingredient of Atenix in the following countries:
- Chile
International Drug Name Search
Mastalone Blue
Mastalone Blue may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Mastalone Blue
Neomycin
Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Mastalone Blue in the following countries:
- Australia
Oleandomycin
Oleandomycin phosphate (a derivative of Oleandomycin) is reported as an ingredient of Mastalone Blue in the following countries:
- Australia
Oxytetracycline
Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Mastalone Blue in the following countries:
- Australia
International Drug Name Search
Rilménidine Ratiopharm
Rilménidine Ratiopharm may be available in the countries listed below.
Ingredient matches for Rilménidine Ratiopharm
Rilmenidine
Rilmenidine dihydrogen phosphate (a derivative of Rilmenidine) is reported as an ingredient of Rilménidine Ratiopharm in the following countries:
- France
International Drug Name Search
Trimesan
Trimesan may be available in the countries listed below.
Ingredient matches for Trimesan
Trimethoprim
Trimethoprim is reported as an ingredient of Trimesan in the following countries:
- Poland
International Drug Name Search
Fentatienil
Fentatienil may be available in the countries listed below.
Ingredient matches for Fentatienil
Sufentanil
Sufentanil citrate (a derivative of Sufentanil) is reported as an ingredient of Fentatienil in the following countries:
- Italy
International Drug Name Search
Thursday, October 13, 2016
Haloperidol PCH
Haloperidol PCH may be available in the countries listed below.
Ingredient matches for Haloperidol PCH
Haloperidol
Haloperidol is reported as an ingredient of Haloperidol PCH in the following countries:
- Netherlands
International Drug Name Search
Erisine
Erisine may be available in the countries listed below.
Ingredient matches for Erisine
Erythromycin
Erythromycin ethylsuccinate (a derivative of Erythromycin) is reported as an ingredient of Erisine in the following countries:
- Argentina
International Drug Name Search
Finasterida Ranbaxy
Finasterida Ranbaxy may be available in the countries listed below.
Ingredient matches for Finasterida Ranbaxy
Finasteride
Finasteride is reported as an ingredient of Finasterida Ranbaxy in the following countries:
- Spain
International Drug Name Search
Wednesday, October 12, 2016
Itraconazolo Sandoz
Itraconazolo Sandoz may be available in the countries listed below.
Ingredient matches for Itraconazolo Sandoz
Itraconazole
Itraconazole is reported as an ingredient of Itraconazolo Sandoz in the following countries:
- Italy
International Drug Name Search
Arketis
Arketis may be available in the countries listed below.
Ingredient matches for Arketis
Paroxetine
Paroxetine is reported as an ingredient of Arketis in the following countries:
- Poland
- Slovakia
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Arketis in the following countries:
- Estonia
- Latvia
- Lithuania
- Malta
- Romania
International Drug Name Search
Tuesday, October 11, 2016
Ridazin
Ridazin may be available in the countries listed below.
Ingredient matches for Ridazin
Thioridazine
Thioridazine hydrochloride (a derivative of Thioridazine) is reported as an ingredient of Ridazin in the following countries:
- Israel
International Drug Name Search
Bromazepam Calox
Bromazepam Calox may be available in the countries listed below.
Ingredient matches for Bromazepam Calox
Bromazepam
Bromazepam is reported as an ingredient of Bromazepam Calox in the following countries:
- Venezuela
International Drug Name Search
Benzalcor
Benzalcor may be available in the countries listed below.
Ingredient matches for Benzalcor
Benzyl Benzoate
Benzyl Benzoate is reported as an ingredient of Benzalcor in the following countries:
- Venezuela
International Drug Name Search
Pindolol Ohara
Pindolol Ohara may be available in the countries listed below.
Ingredient matches for Pindolol Ohara
Pindolol
Pindolol is reported as an ingredient of Pindolol Ohara in the following countries:
- Japan
International Drug Name Search
Monday, October 10, 2016
Lansoprazol Genfar
Lansoprazol Genfar may be available in the countries listed below.
Ingredient matches for Lansoprazol Genfar
Lansoprazole
Lansoprazole is reported as an ingredient of Lansoprazol Genfar in the following countries:
- Colombia
- Ecuador
- Peru
International Drug Name Search
Amlodipine CristerS
Amlodipine CristerS may be available in the countries listed below.
Ingredient matches for Amlodipine CristerS
Amlodipine
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipine CristerS in the following countries:
- France
International Drug Name Search
Captopril + Idroclorotiazide Hexal
Captopril + Idroclorotiazide Hexal may be available in the countries listed below.
Ingredient matches for Captopril + Idroclorotiazide Hexal
Captopril
Captopril is reported as an ingredient of Captopril + Idroclorotiazide Hexal in the following countries:
- Italy
Hydrochlorothiazide
Hydrochlorothiazide is reported as an ingredient of Captopril + Idroclorotiazide Hexal in the following countries:
- Italy
International Drug Name Search
Bricanyl Respirator
Bricanyl Respirator may be available in the countries listed below.
Ingredient matches for Bricanyl Respirator
Terbutaline
Terbutaline sulfate (a derivative of Terbutaline) is reported as an ingredient of Bricanyl Respirator in the following countries:
- Ireland
International Drug Name Search
Amantadin Hexal
Amantadin Hexal may be available in the countries listed below.
Ingredient matches for Amantadin Hexal
Amantadine
Amantadine sulfate (a derivative of Amantadine) is reported as an ingredient of Amantadin Hexal in the following countries:
- Germany
International Drug Name Search
Gamolenic Acid
In some countries, this medicine may only be approved for veterinary use.
Scheme
Rec.INN
ATC (Anatomical Therapeutic Chemical Classification)
D11AX02
CAS registry number (Chemical Abstracts Service)
0000506-26-3
Chemical Formula
C18-H30-O2
Molecular Weight
278
Therapeutic Category
Dermatological agent
Chemical Name
(Z,Z,Z)-Octadeca-6,9,12-trienoic acid
Foreign Names
- Acidum gamolenicum (Latin)
- Gamolensäure (German)
- Acide gamolénique (French)
- Acido gamolenico (Spanish)
Generic Names
- Gamolenic Acid (OS: BAN)
- Gamolénique (acide) (OS: DCF)
- Linolenic acid, þ- (IS)
Brand Names
- Epogam
Zeller, Switzerland - Eve
Biofarma, Venezuela - Gla-120
Dr Reddys, Sri Lanka - NorCoat (veterinary use)
Norbrook, United Kingdom
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Sunday, October 9, 2016
Paxt
Paxt may be available in the countries listed below.
Ingredient matches for Paxt
Paroxetine
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Paxt in the following countries:
- Ireland
International Drug Name Search
Remeron
In the US, Remeron (mirtazapine systemic) is a member of the drug class tetracyclic antidepressants and is used to treat Anxiety, Depression, Hot Flashes and Insomnia.
US matches:
- Remeron
- Remeron SolTab Orally Disintegrating Tablets
- Remeron SolTab
- Remeron RD
- Remeron Tablets
Ingredient matches for Remeron
Mirtazapine
Mirtazapine is reported as an ingredient of Remeron in the following countries:
- Argentina
- Australia
- Austria
- Bahrain
- Brazil
- Canada
- China
- Colombia
- Costa Rica
- Croatia (Hrvatska)
- Cyprus
- Czech Republic
- Denmark
- Dominican Republic
- Egypt
- El Salvador
- Estonia
- Finland
- Greece
- Guatemala
- Honduras
- Hong Kong
- Hungary
- Iceland
- Indonesia
- Iran
- Iraq
- Israel
- Italy
- Jordan
- Kuwait
- Latvia
- Lebanon
- Libya
- Lithuania
- Mexico
- Netherlands
- Nicaragua
- Norway
- Oman
- Panama
- Peru
- Philippines
- Poland
- Portugal
- Qatar
- Romania
- Saudi Arabia
- Serbia
- Singapore
- Slovakia
- South Africa
- Sudan
- Sweden
- Switzerland
- Syria
- Taiwan
- Thailand
- Turkey
- United Arab Emirates
- United States
- Venezuela
- Vietnam
- Yemen
International Drug Name Search
Meptin Mini
Meptin Mini may be available in the countries listed below.
Ingredient matches for Meptin Mini
Procaterol
Procaterol hydrochloride (a derivative of Procaterol) is reported as an ingredient of Meptin Mini in the following countries:
- Japan
International Drug Name Search
Insulatard Penfill
Insulatard Penfill may be available in the countries listed below.
Ingredient matches for Insulatard Penfill
Insulin, Isophane
Insulin, Isophane human (a derivative of Insulin, Isophane) is reported as an ingredient of Insulatard Penfill in the following countries:
- Belgium
- Croatia (Hrvatska)
- Sweden
International Drug Name Search
Saturday, October 8, 2016
Tytrix-10
Tytrix-10 may be available in the countries listed below.
Ingredient matches for Tytrix-10
Lisinopril
Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Tytrix-10 in the following countries:
- Vietnam
International Drug Name Search
Pirbutérol
Pirbutérol may be available in the countries listed below.
Ingredient matches for Pirbutérol
Pirbuterol
Pirbutérol (DCF) is known as Pirbuterol in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Click for further information on drug naming conventions and International Nonproprietary Names.
Amlodipina Gen Med
Amlodipina Gen Med may be available in the countries listed below.
Ingredient matches for Amlodipina Gen Med
Amlodipine
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipina Gen Med in the following countries:
- Argentina
International Drug Name Search
Asprim
Asprim may be available in the countries listed below.
Ingredient matches for Asprim
Aspirin
Acetylsalicylic Acid is reported as an ingredient of Asprim in the following countries:
- Dominican Republic
International Drug Name Search
Amifostine
In the US, Amifostine (amifostine systemic) is a member of the drug class antineoplastic detoxifying agents and is used to treat Cancer, Non-Small Cell Lung Cancer and Ovarian Cancer.
US matches:
- Amifostine
- Amifostine Intravenous
Scheme
Rec.INN
ATC (Anatomical Therapeutic Chemical Classification)
V03AF05
CAS registry number (Chemical Abstracts Service)
0020537-88-6
Chemical Formula
C5-H15-N2-O3-P-S
Molecular Weight
214
Therapeutic Categories
Antidote
Radioprotective agent
Chemical Name
S-[2-[(3-Aminopropyl)amino]ethyl] dihydrogen phosphorothioate
Foreign Names
- Amifostinum (Latin)
- Amifostin (German)
- Amifostine (French)
- Amifostina (Spanish)
Generic Names
- Amifostine (OS: BAN, USAN, DCF)
- Ethiofos (IS: USAN)
- Gammaphos (IS)
- NSC 296961 (IS)
- WR 2721 (IS)
- YM 08310 (IS: Yamanouchi)
- Amifostine (PH: USP 32)
- Amifostine (PH: USP 30)
Brand Names
- Amifostine
Sun, United States - Amiphos
Dabur, India - Ethyol
AFM-BO, Italy; Er-Kim, Turkey; Essex, Germany; Genopharm, Finland; Genopharm, France; MedImmune, United States; Pinnacle Biologies, Netherlands; Schering-Plough, Australia; Schering-Plough, Belgium; Schering-Plough, Bahrain; Schering-Plough, Brazil; Schering-Plough, Chile; Schering-Plough, Colombia; Schering-Plough, Costa Rica; Schering-Plough, Czech Republic; Schering-Plough, Dominican Republic; Schering-Plough, Spain; Schering-Plough, Guatemala; Schering-Plough, Honduras; Schering-Plough, Mexico; Schering-Plough, Nicaragua; Schering-Plough, New Zealand; Schering-Plough, Panama; Schering-Plough, Philippines; Schering-Plough, Portugal; Schering-Plough, Romania; Schering-Plough, El Salvador; Schering-Plough, Thailand; Schering-Plough, Taiwan; Schering-Plough, Venezuela; Teva, Israel - Erifostine
Teva, Argentina - Ethyol
Pinnacle Biologicals, Greece; Schering-Plough, South Africa
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Ketok
Ketok may be available in the countries listed below.
Ingredient matches for Ketok
Ketoprofen
Ketoprofen is reported as an ingredient of Ketok in the following countries:
- Japan
International Drug Name Search
Milfadin
Milfadin may be available in the countries listed below.
Ingredient matches for Milfadin
Nifedipine
Nifedipine is reported as an ingredient of Milfadin in the following countries:
- Japan
International Drug Name Search
Friday, October 7, 2016
Terazosin PCD
Terazosin PCD may be available in the countries listed below.
Ingredient matches for Terazosin PCD
Terazosin
Terazosin hydrochloride (a derivative of Terazosin) is reported as an ingredient of Terazosin PCD in the following countries:
- Denmark
International Drug Name Search
Loratadina Bexal
Loratadina Bexal may be available in the countries listed below.
Ingredient matches for Loratadina Bexal
Loratadine
Loratadine is reported as an ingredient of Loratadina Bexal in the following countries:
- Spain
International Drug Name Search
Eparina Calcica Mylan
Eparina Calcica Mylan may be available in the countries listed below.
Ingredient matches for Eparina Calcica Mylan
Heparin
Heparin calcium salt (a derivative of Heparin) is reported as an ingredient of Eparina Calcica Mylan in the following countries:
- Italy
International Drug Name Search
Thursday, October 6, 2016
Lenirit
Lenirit may be available in the countries listed below.
Ingredient matches for Lenirit
Hydrocortisone
Hydrocortisone 21-acetate (a derivative of Hydrocortisone) is reported as an ingredient of Lenirit in the following countries:
- Italy
International Drug Name Search
Ratio-Morphine
ratio-Morphine may be available in the countries listed below.
Ingredient matches for ratio-Morphine
Morphine
Morphine hydrochloride (a derivative of Morphine) is reported as an ingredient of ratio-Morphine in the following countries:
- Canada
International Drug Name Search
Akamon
Akamon may be available in the countries listed below.
Ingredient matches for Akamon
Bromazepam
Bromazepam is reported as an ingredient of Akamon in the following countries:
- Cyprus
- Hong Kong
- Iraq
- Jordan
- Malta
- Sudan
- Taiwan
- Yemen
International Drug Name Search
Gabtin
Gabtin may be available in the countries listed below.
Ingredient matches for Gabtin
Gabapentin
Gabapentin is reported as an ingredient of Gabtin in the following countries:
- Turkey
International Drug Name Search
Arlidin
Arlidin may be available in the countries listed below.
Ingredient matches for Arlidin
Buphenine
Buphenine hydrochloride (a derivative of Buphenine) is reported as an ingredient of Arlidin in the following countries:
- India
- Mexico
International Drug Name Search
Wednesday, October 5, 2016
Coleretik
Coleretik may be available in the countries listed below.
Ingredient matches for Coleretik
Ursodeoxycholic Acid
Ursodeoxycholic Acid is reported as an ingredient of Coleretik in the following countries:
- Peru
International Drug Name Search
Aviclens
Aviclens may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Aviclens
Chlorhexidine
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Aviclens in the following countries:
- Australia
International Drug Name Search
Moxic
Moxic may be available in the countries listed below.
Ingredient matches for Moxic
Meloxicam
Meloxicam is reported as an ingredient of Moxic in the following countries:
- Indonesia
International Drug Name Search
Ramipril 5mg Tablets
1. Name Of The Medicinal Product
Ramipril 5mg Tablets
2. Qualitative And Quantitative Composition
5 mg ramipril.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Tablet
Pale red oblong tablets with score-line.
Upper stamp: 5 & logo (
Lower stamp: HMP & 5
4. Clinical Particulars
4.1 Therapeutic Indications
- Treatment of hypertension.
- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:
o manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or
o diabetes with at least one cardiovascular risk factor (see section 5.1).
- Treatment of renal disease:
o Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria,
o Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1),
o Manifest glomerular non diabetic nephropathy as defined by macroproteinuria
- Treatment of symptomatic heart failure.
- Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started> 48 hours following acute myocardial infarction.
4.2 Posology And Method Of Administration
Oral use.
It is recommended that RAMIPRIL is taken each day at the same time of the day.
RAMIPRIL can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
RAMIPRIL has to be swallowed with liquid. It must not be chewed or crushed.
Adults
Diuretic-Treated patients
Hypotension may occur following initiation of therapy with RAMIPRIL; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted.
If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with RAMIPRIL (see section 4.4).
In hypertensive patients in whom the diuretic is not discontinued, therapy with RAMIPRIL should be initiated with a 1.25 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of RAMIPRIL should be adjusted according to blood pressure target.
Hypertension
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
RAMIPRIL may be used in monotherapy or in combination with other classes of antihypertensive medicinal products.
Starting dose
RAMIPRIL should be started gradually with an initial recommended dose of 2.5 mg daily.
Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose. A starting dose of 1.25 mg is recommended in such patients and the initiation of treatment should take place under medical supervision (see section 4.4).
Titration and maintenance dose
The dose can be doubled at interval of two to four weeks to progressively achieve target blood
pressure; the maximum permitted dose of RAMIPRIL is 10 mg daily. Usually the dose is administered once daily.
Cardiovascular prevention
Starting dose
The recommended initial dose is 2.5 mg of RAMIPRIL once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose should be gradually increased. It is recommended to double the dose after one or two weeks of treatment and - after another two to three weeks - to increase it up to the target maintenance dose of 10 mg RAMIPRIL once daily.
See also posology on diuretic treated patients above.
Treatment of renal disease
In patients with diabetes and microalbuminuria:
Starting dose:
The recommended initial dose is 1.25 mg of RAMIPRIL once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.
In patients with diabetes and at least one cardiovascular risk
Starting dose:
The recommended initial dose is 2.5 mg of RAMIPRIL once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the daily dose to 5 mg RAMIPRIL after one or two weeks and then to 10 mg RAMIPRIL after a further two or three weeks is recommended. The target daily dose is 10 mg.
In patients with non- diabetic nephropathy as defined by macroproteinuria
Starting dose:
The recommended initial dose is 1.25 mg of RAMIPRIL once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.
Symptomatic heart failure
Starting dose
In patients stabilized on diuretic therapy, the recommended initial dose is 1.25 mg daily.
Titration and maintenance dose
RAMIPRIL should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10 mg. Two administrations per day are preferable.
Secondary prevention after acute myocardial infarction and with heart failure
Starting dose
After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days. If the initial 2.5 mg dose is not tolerated a dose of 1.25 mg twice a day should be given for two days before increasing to 2.5 mg and 5 mg twice a day. If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdrawn.
See also posology on diuretic treated patients above.
Titration and maintenance dose
The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5 mg twice daily.
The maintenance dose is divided in 2 administrations per day where possible.
If the dose cannot be increased to 2.5 mg twice a day treatment should be withdrawn. Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction. Should the decision be taken to treat these patients, it is recommended that therapy be started at 1.25 mg once daily and that particular caution be exercised in any dose increase.
Special populations
Patients with renal impairment
Daily dose in patients with renal impairment should be based on creatinine clearance (see section 5.2):
- if creatinine clearance is
- if creatinine clearance is between 30-60 ml/min, it is not necessary to adjust the initial dose (2.5 mg/day); the maximal daily dose is 5 mg;
- if creatinine clearance is between 10-30 ml/min, the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg;
- in haemodialysed hypertensive patients: ramipril is slightly dialysable; the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg; the medicinal product should be administered few hours after haemodialysis is performed.
Patients with hepatic impairment (see section 5.2)
In patients with hepatic impairment, treatment with RAMIPRIL must be initiated only under close medical supervision and the maximum daily dose is 2.5 mg RAMIPRIL.
Elderly
Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients. A reduced initial dose of 1.25 mg ramipril should be considered.
Paediatric population
RAMIPRIL is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
4.3 Contraindications
- Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin Converting Enzyme) inhibitors (see section 6.1)
- History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs)
- Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5)
- Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
- 2nd and 3rd trimester of pregnancy (see sections 4.4 and 4.6)
- Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
4.4 Special Warnings And Precautions For Use
Special populations
Pregnancy: ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Patients at particular risk of hypotension
Patients with strongly activated renin-angiotensin-aldosterone system:
Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.
Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in:
- patients with severe hypertension
- patients with decompensated congestive heart failure
- patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g. stenosis of the aortic or mitral valve)
- patients with unilateral renal artery stenosis with a second functional kidney
- patients in whom fluid or salt depletion exists or may develop (including patients with diuretics)
- patients with liver cirrhosis and/or ascites
- patients undergoing major surgery or during anaesthesia with agents that produce hypotension.
Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload).
Transient or persistent heart failure post MI
Patients at risk of cardiac or cerebral ischemia in case of acute hypotension
The initial phase of treatment requires special medical supervision.
Elderly patients
See section 4.2.
Surgery
It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
Monitoring of renal function
Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment. Particularly careful monitoring is required in patients with renal impairment (see section 4.2). There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant.
Angioedema
Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see
section 4.8).
In case of angioedema, RAMIPRIL must be discontinued.
Emergency therapy should be instituted promptly. Patient should be kept under observation for at least 12 to 24 hours and discharged after complete resolution of the symptoms.
Intestinal angioedema has been reported in patients treated with ACE inhibitors including RAMIPRIL (see section 4.8). These patients presented with abdominal pain (with or without nausea or vomiting).
Anaphylactic reactions during desensitization
The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition. A temporary discontinuation of RAMIPRIL should be considered prior to desensitization.
Hyperkalaemia
Hyperkalaemia has been observed in some patients treated with ACE inhibitors including RAMIPRIL. Patients at risk for development of hyperkalaemia include those with renal insufficiency, age (> 70 years), uncontrolled diabetes mellitus, or those using potassium salts, potassium retaining diuretics and other plasma potassium increasing active substances, or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis. If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
Neutropenia/agranulocytosis
Neutropenia/agranulocytosis, as well as thrombocytopenia and anaemia, have been rarely seen and bone marrow depression has also been reported. It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia. More frequent monitoring is advised in the initial phase of treatment and in patients with impaired renal function, those with concomitant collagen disease (e.g. lupus erythematosus or scleroderma), and all those treated with other medicinal products that can cause changes in the blood picture (see sections 4.5 and 4.8).
Ethnic differences
ACE inhibitors cause higher rate of angioedema in black patients than in non black patients.
As with other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black people than in non black patients, possibly because of a higher prevalence of hypertension with low renin level in the black hypertensive population.
Cough
Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy. ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Contra-indicated combinations
Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e.g. polyacrylonitril membranes) and low density lipoprotein apheresis with dextran sulphate due to increased risk of severe anaphylactoid reactions (see section 4.3). If such treatment is required, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
Precautions for use
Potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances (including Angiotensin II antagonists, trimethoprim, tacrolimus, ciclosporin): Hyperkalaemia may occur, therefore close monitoring of serum potassium is required.
Antihypertensive agents (e.g. diuretics) and other substances that may decrease blood pressure (e.g.nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin): Potentiation of the risk of hypotension is to be anticipated (see section 4.2 for diuretics)
Vasopressor sympathomimetics and other substances (e.g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of RAMIPRIL: Blood pressure monitoring is recommended.
Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count: Increased likelihood of haematological reactions (see section 4.4).
Lithium salts: Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased. Lithium level must be monitored.
Antidiabetic agents including insulin: Hypoglycaemic reactions may occur. Blood glucose monitoring is recommended.
Non-steroidal anti-inflammatory drugs and acetylsalicylic acid: Reduction of the antihypertensive effect of RAMIPRIL is to be anticipated. Furthermore, concomitant treatment of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function and to an increase in kalaemia.
4.6 Pregnancy And Lactation
RAMIPRIL is not recommended during the first trimester of pregnancy (see section 4.4) and contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started. ACE inhibitor/ Angiotensin II Receptor Antagonist (AIIRA) therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (See also 5.3 'Preclinical safety data'). Should exposure to ACE inhibitor have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Newborns whose mothers have taken ACE inhibitors should be closely observed for hypotension, oliguria and
hyperkalaemia (see also sections 4.3 and 4.4).
Because insufficient information is available regarding the use of ramipril during breastfeeding (see section 5.2), ramipril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
4.7 Effects On Ability To Drive And Use Machines
Some adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient's ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).
This can happen especially at the start of treatment, or when changing over from other preparations. After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.
4.8 Undesirable Effects
The safety profile of ramipril includes persistent dry cough and reactions due to hypotension. Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.
Adverse reactions frequency is defined using the following convention:
Very common (
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
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4.9 Overdose
Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral
vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure. The patient should be closely monitored and the treatment should be symptomatic and supportive. Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration. Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: ACE Inhibitors, plain, ATC code C09AA05.
Mechanism of action
Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II). In plasma and tissue this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin. Reduced angiotensin II formation and inhibition of bradykinin breakdown lead to vasodilatation.
Since angiotensin II also stimulates the release of aldosterone, ramiprilat causes a reduction in aldosterone secretion. The average response to ACE inhibitor monotherapy was lower in black (Afro-Caribbean) hypertensive patients (usually a low-renin hypertensive population) than in non-black patients.
Pharmacodynamic effects
Antihypertensive properties:
Administration of ramipril causes a marked reduction in peripheral arterial resistance. Generally, there are no major changes in renal plasma flow and glomerular filtration rate. Administration of ramipril to patients with hypertension leads to a reduction in supine and standing blood pressure without a compensatory rise in heart rate.
In most patients the onset of the antihypertensive effect of a single dose becomes apparent 1 to 2 hours after oral administration. The peak effect of a single dose is usually reached 3 to 6 hours after oral administration. The antihypertensive effect of a single dose usually lasts for 24 hours.
The maximum antihypertensive effect of continued treatment with ramipril is generally apparent after 3 to 4 weeks. It has been shown that the antihypertensive effect is sustained under long term therapy lasting 2 years.
Abrupt discontinuation of ramipril does not produce a rapid and excessive rebound increase in blood pressure.
Heart failure:
In addition to conventional therapy with diuretics and optional cardiac glycosides, ramipril has been shown to be effective in patients with functional classes II-IV of the New-York Heart Association. The drug had beneficial effects on cardiac haemodynamics (decreased left and right ventricular filling pressures, reduced total peripheral vascular resistance, increased cardiac output and improved cardiac index). It also reduced neuroendocrine activation.
Clinical efficacy and safety
Cardiovascular prevention/Nephroprotection;
A preventive placebo-controlled study (the HOPE-study), was carried out in which ramipril was added to standard therapy in more than 9,200 patients. Patients with increased risk of cardiovascular disease following either atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or peripheral vascular disease) or diabetes mellitus with at least one additional risk factor (documented microalbuminuria, hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level or cigarette smoking) were included in the study.
The study showed that ramipril statistically significantly decreases the incidence of myocardial infarction, death from cardiovascular causes and stroke, alone and combined (primary combined events).
The HOPE Study: Main Results;
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