Lertamine may be available in the countries listed below.
Ingredient matches for Lertamine
Loratadine
Loratadine is reported as an ingredient of Lertamine in the following countries:
- Mexico
International Drug Name Search
Thursday, October 27, 2016
Rifacol
Rifacol may be available in the countries listed below.
Ingredient matches for Rifacol
Rifaximin
Rifaximin is reported as an ingredient of Rifacol in the following countries:
- Italy
International Drug Name Search
Gen-Warfarin
Gen-Warfarin may be available in the countries listed below.
Ingredient matches for Gen-Warfarin
Warfarin
Warfarin sodium salt (a derivative of Warfarin) is reported as an ingredient of Gen-Warfarin in the following countries:
- Canada
International Drug Name Search
Wednesday, October 26, 2016
Felodipin AL
Felodipin AL may be available in the countries listed below.
Ingredient matches for Felodipin AL
Felodipine
Felodipine is reported as an ingredient of Felodipin AL in the following countries:
- Czech Republic
- Germany
- Romania
International Drug Name Search
Loxof
Loxof may be available in the countries listed below.
Ingredient matches for Loxof
Levofloxacin
Levofloxacin is reported as an ingredient of Loxof in the following countries:
- Peru
International Drug Name Search
Berifen
Berifen may be available in the countries listed below.
Ingredient matches for Berifen
Diclofenac
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Berifen in the following countries:
- Costa Rica
- El Salvador
- Guatemala
- Honduras
- Nicaragua
- Panama
International Drug Name Search
Benztrop
Benztrop may be available in the countries listed below.
Ingredient matches for Benztrop
Benzatropine
Benzatropine mesilate (a derivative of Benzatropine) is reported as an ingredient of Benztrop in the following countries:
- Australia
- New Zealand
International Drug Name Search
Tensan retard
Tensan retard may be available in the countries listed below.
Ingredient matches for Tensan retard
Nilvadipine
Nilvadipine is reported as an ingredient of Tensan retard in the following countries:
- Austria
International Drug Name Search
Tuesday, October 25, 2016
Flupollon
Flupollon may be available in the countries listed below.
Ingredient matches for Flupollon
Fluocinolone
Fluocinolone Acetonide is reported as an ingredient of Flupollon in the following countries:
- Japan
International Drug Name Search
Carve TAD
Carve TAD may be available in the countries listed below.
Ingredient matches for Carve TAD
Carvedilol
Carvedilol is reported as an ingredient of Carve TAD in the following countries:
- Germany
International Drug Name Search
Enurace
Enurace may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Enurace
Ephedrine
Ephedrine hydrochloride (a derivative of Ephedrine) is reported as an ingredient of Enurace in the following countries:
- Netherlands
International Drug Name Search
Anginox
Anginox may be available in the countries listed below.
Ingredient matches for Anginox
Trimetazidine
Trimetazidine dihydrochloride (a derivative of Trimetazidine) is reported as an ingredient of Anginox in the following countries:
- Bangladesh
International Drug Name Search
Medinol
Medinol may be available in the countries listed below.
UK matches:
- Medinol Paediatric Paracetamol Oral Suspension BP 120mg/5ml (SPC)
Ingredient matches for Medinol
Paracetamol
Paracetamol is reported as an ingredient of Medinol in the following countries:
- Malta
- 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.
Poloxamer 188
Poloxamer 188 may be available in the countries listed below.
Ingredient matches for Poloxamer 188
Poloxamer
Poloxamer 188 (JAN) is also known as Poloxamer (Rec.INN)
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Monday, October 24, 2016
Minims Fluoreszein Natrium
Minims Fluoreszein Natrium may be available in the countries listed below.
Ingredient matches for Minims Fluoreszein Natrium
Fluorescein
Fluorescein sodium (a derivative of Fluorescein) is reported as an ingredient of Minims Fluoreszein Natrium in the following countries:
- Austria
International Drug Name Search
Finasterida Jaba
Finasterida Jaba may be available in the countries listed below.
Ingredient matches for Finasterida Jaba
Finasteride
Finasteride is reported as an ingredient of Finasterida Jaba in the following countries:
- Portugal
International Drug Name Search
Sunday, October 23, 2016
Fenilbutazonã
Fenilbutazonã may be available in the countries listed below.
Ingredient matches for Fenilbutazonã
Phenylbutazone
Phenylbutazone is reported as an ingredient of Fenilbutazonã in the following countries:
- Romania
International Drug Name Search
Flea Control
Flea Control may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Flea Control
Piperonyl Butoxide
Piperonyl Butoxide is reported as an ingredient of Flea Control in the following countries:
- Australia
Pyrethrin I
Pyrethrin I is reported as an ingredient of Flea Control in the following countries:
- Australia
International Drug Name Search
Cyproteron / Ethinylestradiol Ratiopharm
Cyproteron / Ethinylestradiol Ratiopharm may be available in the countries listed below.
Ingredient matches for Cyproteron / Ethinylestradiol Ratiopharm
Cyproterone
Cyproterone 17α-acetate (a derivative of Cyproterone) is reported as an ingredient of Cyproteron / Ethinylestradiol Ratiopharm in the following countries:
- Netherlands
Ethinylestradiol
Ethinylestradiol is reported as an ingredient of Cyproteron / Ethinylestradiol Ratiopharm in the following countries:
- Netherlands
International Drug Name Search
Flaveric
Flaveric may be available in the countries listed below.
Ingredient matches for Flaveric
Benproperine
Benproperine dihydrogen phosphate (a derivative of Benproperine) is reported as an ingredient of Flaveric in the following countries:
- Japan
International Drug Name Search
HCG Mochida
HCG Mochida may be available in the countries listed below.
Ingredient matches for HCG Mochida
Chorionic Gonadotrophin
Chorionic Gonadotrophin is reported as an ingredient of HCG Mochida in the following countries:
- Japan
International Drug Name Search
Hibideks DAP
Hibideks DAP may be available in the countries listed below.
Ingredient matches for Hibideks DAP
Chlorhexidine
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Hibideks DAP in the following countries:
- Serbia
International Drug Name Search
Xao
Xao may be available in the countries listed below.
Ingredient matches for Xao
Tobramycin
Tobramycin is reported as an ingredient of Xao in the following countries:
- Argentina
International Drug Name Search
Saturday, October 22, 2016
Minias
Minias may be available in the countries listed below.
Ingredient matches for Minias
Lormetazepam
Lormetazepam is reported as an ingredient of Minias in the following countries:
- Italy
International Drug Name Search
Clorfenamina
Clorfenamina may be available in the countries listed below.
Ingredient matches for Clorfenamina
Chlorphenamine
Clorfenamina (DCIT) is also known as Chlorphenamine (Rec.INN)
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Friday, October 21, 2016
Corsadol
Corsadol may be available in the countries listed below.
Ingredient matches for Corsadol
Tramadol
Tramadol is reported as an ingredient of Corsadol in the following countries:
- Indonesia
International Drug Name Search
Piracétam Ratiopharm
Piracétam Ratiopharm may be available in the countries listed below.
Ingredient matches for Piracétam Ratiopharm
Piracetam
Piracetam is reported as an ingredient of Piracétam Ratiopharm in the following countries:
- France
International Drug Name Search
Jutabloc
Jutabloc may be available in the countries listed below.
Ingredient matches for Jutabloc
Metoprolol
Metoprolol tartrate (a derivative of Metoprolol) is reported as an ingredient of Jutabloc in the following countries:
- Germany
International Drug Name Search
Thursday, October 20, 2016
Conrax
Conrax may be available in the countries listed below.
Ingredient matches for Conrax
Chlorpromazine
Chlorpromazine hydrochloride (a derivative of Chlorpromazine) is reported as an ingredient of Conrax in the following countries:
- Argentina
International Drug Name Search
Troxerutin Leciva
Troxerutin Leciva may be available in the countries listed below.
Ingredient matches for Troxerutin Leciva
Troxerutin
Troxerutin is reported as an ingredient of Troxerutin Leciva in the following countries:
- Russian Federation
International Drug Name Search
Rinityn
Rinityn may be available in the countries listed below.
Ingredient matches for Rinityn
Loratadine
Loratadine is reported as an ingredient of Rinityn in the following countries:
- Philippines
- Singapore
International Drug Name Search
Avidazine
Avidazine may be available in the countries listed below.
Ingredient matches for Avidazine
Cinnarizine
Cinnarizine is reported as an ingredient of Avidazine in the following countries:
- India
International Drug Name Search
Haloperidol Decanoate
Ingredient matches for Haloperidol Decanoate
Haloperidol
Haloperidol Decanoate (BANM, USAN) is known as Haloperidol 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.
Idon
Idon may be available in the countries listed below.
Ingredient matches for Idon
Domperidone
Domperidone is reported as an ingredient of Idon in the following countries:
- Chile
- Peru
International Drug Name Search
Athmyl
Athmyl may be available in the countries listed below.
Ingredient matches for Athmyl
Mianserin
Mianserin hydrochloride (a derivative of Mianserin) is reported as an ingredient of Athmyl in the following countries:
- Oman
International Drug Name Search
Bicalutamida Cinfa
Bicalutamida Cinfa may be available in the countries listed below.
Ingredient matches for Bicalutamida Cinfa
Bicalutamide
Bicalutamide is reported as an ingredient of Bicalutamida Cinfa in the following countries:
- Spain
International Drug Name Search
Belmazol
Belmazol may be available in the countries listed below.
Ingredient matches for Belmazol
Citalopram
Citalopram is reported as an ingredient of Belmazol in the following countries:
- Greece
Omeprazole
Omeprazole is reported as an ingredient of Belmazol in the following countries:
- Spain
International Drug Name Search
Wednesday, October 19, 2016
Levospa
Levospa may be available in the countries listed below.
Ingredient matches for Levospa
Dehydroepiandrosterone
Prasterone sodium sulfate hydrate (a derivative of Prasterone) is reported as an ingredient of Levospa in the following countries:
- Japan
International Drug Name Search
Belepar
Belepar may be available in the countries listed below.
Ingredient matches for Belepar
Benserazide
Benserazide is reported as an ingredient of Belepar in the following countries:
- Poland
Levodopa
Levodopa is reported as an ingredient of Belepar in the following countries:
- Poland
International Drug Name Search
ASA-Tabs
ASA-Tabs may be available in the countries listed below.
Ingredient matches for ASA-Tabs
Aspirin
Acetylsalicylic Acid is reported as an ingredient of ASA-Tabs in the following countries:
- Switzerland
International Drug Name Search
Amitrex
Amitrex may be available in the countries listed below.
Ingredient matches for Amitrex
Amisulpride
Amisulpride is reported as an ingredient of Amitrex in the following countries:
- Hungary
- Portugal
International Drug Name Search
Medalin
Medalin may be available in the countries listed below.
Ingredient matches for Medalin
Famotidine
Famotidine is reported as an ingredient of Medalin in the following countries:
- Venezuela
International Drug Name Search
Tuesday, October 18, 2016
Puresis
Puresis may be available in the countries listed below.
Ingredient matches for Puresis
Furosemide
Furosemide is reported as an ingredient of Puresis in the following countries:
- South Africa
International Drug Name Search
InfectoCipro
InfectoCipro may be available in the countries listed below.
Ingredient matches for InfectoCipro
Ciprofloxacin
Ciprofloxacin is reported as an ingredient of InfectoCipro in the following countries:
- Germany
International Drug Name Search
Monday, October 17, 2016
Lipex
Lipex may be available in the countries listed below.
Ingredient matches for Lipex
Atorvastatin
Atorvastatin calcium (a derivative of Atorvastatin) is reported as an ingredient of Lipex in the following countries:
- Bangladesh
Polycosanol
Policosanol is reported as an ingredient of Lipex in the following countries:
- Argentina
Simvastatin
Simvastatin is reported as an ingredient of Lipex in the following countries:
- Australia
- Bosnia & Herzegowina
- Croatia (Hrvatska)
- New Zealand
International Drug Name Search
Pharmastatin
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Pharmastatin
Atorvastatin
Atorvastatin calcium (a derivative of Atorvastatin) is reported as an ingredient of Pharmastatin in the following countries:
- Slovakia
Nystatin
Nystatin is reported as an ingredient of Pharmastatin in the following countries:
- United States
International Drug Name Search
Sunday, October 16, 2016
Gastrom
Gastrom may be available in the countries listed below.
Ingredient matches for Gastrom
Ecabet
Ecabet sodium salt (a derivative of Ecabet) is reported as an ingredient of Gastrom in the following countries:
- Japan
International Drug Name Search
Tamoxifen-Eurogenerics
Tamoxifen-Eurogenerics may be available in the countries listed below.
Ingredient matches for Tamoxifen-Eurogenerics
Tamoxifen
Tamoxifen is reported as an ingredient of Tamoxifen-Eurogenerics in the following countries:
- Luxembourg
International Drug Name Search
Methylphenidate Hydrochloride
Ingredient matches for Methylphenidate Hydrochloride
Methylphenidate
Methylphenidate Hydrochloride (BANM, JAN) is known as Methylphenidate in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| JAN | Japanese Accepted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Minims Tropicamide
Minims Tropicamide may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
UK matches:
- Minims Tropicamide
- Minims Tropicamide 0.5% w/v (SPC)
- Minims Tropicamide 1% w/v (SPC)
Ingredient matches for Minims Tropicamide
Tropicamide
Tropicamide is reported as an ingredient of Minims Tropicamide in the following countries:
- Australia
- Hong Kong
- Ireland
- Malta
- Netherlands
- New Zealand
- Oman
- Singapore
- South Africa
- 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.
Lamotrigin-biomo
Lamotrigin-biomo may be available in the countries listed below.
Ingredient matches for Lamotrigin-biomo
Lamotrigine
Lamotrigine is reported as an ingredient of Lamotrigin-biomo in the following countries:
- Germany
International Drug Name Search
Saturday, October 15, 2016
Fluticasonpropionaat Ratiopharm
Fluticasonpropionaat Ratiopharm may be available in the countries listed below.
Ingredient matches for Fluticasonpropionaat Ratiopharm
Fluticasone
Fluticasone propionate (a derivative of Fluticasone) is reported as an ingredient of Fluticasonpropionaat Ratiopharm in the following countries:
- Netherlands
International Drug Name Search
Tobcin
Tobcin may be available in the countries listed below.
Ingredient matches for Tobcin
Tobramycin
Tobramycin sulfate (a derivative of Tobramycin) is reported as an ingredient of Tobcin in the following countries:
- Bangladesh
International Drug Name Search
Kastair
Kastair may be available in the countries listed below.
Ingredient matches for Kastair
Montelukast
Montelukast sodium salt (a derivative of Montelukast) is reported as an ingredient of Kastair in the following countries:
- Philippines
International Drug Name Search
Friday, October 14, 2016
Colazid
Colazid may be available in the countries listed below.
Ingredient matches for Colazid
Balsalazide
Balsalazide disodium salt, dihydrate (a derivative of Balsalazide) is reported as an ingredient of Colazid in the following countries:
- Norway
- Sweden
International Drug Name Search
Butamide
Butamide may be available in the countries listed below.
Ingredient matches for Butamide
Tolbutamide
Tolbutamide is reported as an ingredient of Butamide in the following countries:
- Japan
International Drug Name Search
Fluorescein SAD
Fluorescein SAD may be available in the countries listed below.
Ingredient matches for Fluorescein SAD
Fluorescein
Fluorescein sodium (a derivative of Fluorescein) is reported as an ingredient of Fluorescein SAD in the following countries:
- Denmark
International Drug Name Search
Caltab
Caltab may be available in the countries listed below.
Ingredient matches for Caltab
Calcium Lactate
Calcium Lactate is reported as an ingredient of Caltab in the following countries:
- Bangladesh
International Drug Name Search
Flécaïne
Flécaïne may be available in the countries listed below.
Ingredient matches for Flécaïne
Flecainide
Flecainide is reported as an ingredient of Flécaïne in the following countries:
- Tunisia
Flecainide acetate (a derivative of Flecainide) is reported as an ingredient of Flécaïne in the following countries:
- France
International Drug Name Search
Bicalutamid Hexal
Bicalutamid Hexal may be available in the countries listed below.
Ingredient matches for Bicalutamid Hexal
Bicalutamide
Bicalutamide is reported as an ingredient of Bicalutamid Hexal in the following countries:
- Austria
- Germany
- Luxembourg
International Drug Name Search
Laxans AL
Laxans AL may be available in the countries listed below.
Ingredient matches for Laxans AL
Bisacodyl
Bisacodyl is reported as an ingredient of Laxans AL in the following countries:
- Germany
International Drug Name Search
Madécassol
Madécassol may be available in the countries listed below.
Ingredient matches for Madécassol
Asiaticoside
Asiaticoside is reported as an ingredient of Madécassol in the following countries:
- France
International Drug Name Search
Thursday, October 13, 2016
Cetril
Cetril may be available in the countries listed below.
Ingredient matches for Cetril
Cetirizine
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cetril in the following countries:
- Bangladesh
- Greece
International Drug Name Search
Metocar
Metocar may be available in the countries listed below.
Ingredient matches for Metocar
Metoprolol
Metoprolol tartrate (a derivative of Metoprolol) is reported as an ingredient of Metocar in the following countries:
- Denmark
International Drug Name Search
Altargo
Altargo may be available in the countries listed below.
UK matches:
- Altargo 1% Ointment (SPC)
Ingredient matches for Altargo
Retapamulin
Retapamulin is reported as an ingredient of Altargo in the following countries:
- Austria
- Belgium
- Denmark
- Finland
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Luxembourg
- Netherlands
- Norway
- Slovakia
- Slovenia
- Spain
- Sweden
- Switzerland
- 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.
Actadol Cold-Flu
Actadol Cold-Flu may be available in the countries listed below.
Ingredient matches for Actadol Cold-Flu
Paracetamol
Paracetamol is reported as an ingredient of Actadol Cold-Flu in the following countries:
- Vietnam
Pseudoephedrine
Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Actadol Cold-Flu in the following countries:
- Vietnam
International Drug Name Search
Wednesday, October 12, 2016
Haemaccel
Haemaccel may be available in the countries listed below.
Ingredient matches for Haemaccel
Polygeline
Polygeline is reported as an ingredient of Haemaccel in the following countries:
- Australia
- Bangladesh
- Costa Rica
- Germany
- Greece
- India
- Indonesia
- Israel
- Luxembourg
- Netherlands
- New Zealand
- Romania
- Serbia
- Thailand
International Drug Name Search
Potassium Canrenoate
Scheme
Rec.INN
ATC (Anatomical Therapeutic Chemical Classification)
C03DA02
CAS registry number (Chemical Abstracts Service)
0002181-04-6
Chemical Formula
C22-H29-K-O4
Molecular Weight
396
Therapeutic Category
Potassium-sparing diuretic agent, aldosterone antagonist
Chemical Name
Pregna-4,6-diene-21-carboxylic acid, 17-hydroxy-3-oxo-, monopotassium salt, (17α)-
Foreign Names
- Kalii canrenoas (Latin)
- Kalium canrenoat (German)
- Canrénoate de potassium (French)
- Canrenoato potasico (Spanish)
Generic Names
- Canrenoate Potassium (OS: USAN)
- Canrenoato di potassio (OS: DCIT)
- Potassium Canrenoate (OS: JAN)
- Aldadiene potassium (IS)
- MF 465a (IS)
- SC 14266 (IS)
- Potassium Canrenoate (PH: JP XIV)
Brand Names
- Aldactone
Riemser, Austria; Riemser, Czech Republic; Riemser, Germany - Canrenol
Grünenthal, Belgium; Grünenthal S.A., Luxembourg - Diurek
B&G, Italy - Gascool
Sawai Seiyaku, Japan - Kadiur (Potassium Canrenoate and Butizide)
Therabel, Italy - Kanrenol
Teofarma, Italy - Luvion
GiEnne, Italy - Narmylon
Pola Pharma, Japan - Potassio Canrenoato EG
EG, Italy - Potassio Canrenoato Pensa
Pensa, Italy - Potassio Canrenoato Sandoz
Sandoz, Italy - Soldactone
Continental, Belgium; Continental, Luxembourg; Pfizer, Switzerland; Pfizer, Japan - Soludactone
Pfizer, France - Venectomin
Taiyo Pharmaceutical, Japan
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| 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.
Biopulmin
Biopulmin may be available in the countries listed below.
Ingredient matches for Biopulmin
Erdosteine
Erdosteine is reported as an ingredient of Biopulmin in the following countries:
- Chile
International Drug Name Search
Lignocaine HCl-Fresenius Vials
Lignocaine HCl-Fresenius Vials may be available in the countries listed below.
Ingredient matches for Lignocaine HCl-Fresenius Vials
Lidocaine
Lidocaine hydrochloride monohydrate (a derivative of Lidocaine) is reported as an ingredient of Lignocaine HCl-Fresenius Vials in the following countries:
- South Africa
International Drug Name Search
Tuesday, October 11, 2016
Lozol
In the US, Lozol (indapamide systemic) is a member of the drug class thiazide diuretics and is used to treat Edema and High Blood Pressure.
US matches:
- Lozol
Ingredient matches for Lozol
Indapamide
Indapamide is reported as an ingredient of Lozol in the following countries:
- United States
International Drug Name Search
Irifrin
Irifrin may be available in the countries listed below.
Ingredient matches for Irifrin
Phenylephrine
Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Irifrin in the following countries:
- Russian Federation
International Drug Name Search
Ribofluor
Ribofluor may be available in the countries listed below.
Ingredient matches for Ribofluor
Fluorouracil
Fluorouracil is reported as an ingredient of Ribofluor in the following countries:
- Germany
International Drug Name Search
Laevolac
Laevolac may be available in the countries listed below.
Ingredient matches for Laevolac
Lactulose
Lactulose is reported as an ingredient of Laevolac in the following countries:
- Hong Kong
- Israel
- Italy
- Portugal
- Romania
- Slovakia
- Turkey
International Drug Name Search
Motigest
Motigest may be available in the countries listed below.
Ingredient matches for Motigest
Mosapride
Mosapride citrate dihydrate (a derivative of Mosapride) is reported as an ingredient of Motigest in the following countries:
- Belize
- El Salvador
- Guatemala
- Honduras
International Drug Name Search
Ramipril 2.5mg Tablets
1. Name Of The Medicinal Product
Ramipril 2.5mg Tablets
2. Qualitative And Quantitative Composition
2.5 mg ramipril.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Tablet
Yellowish to yellow oblong tablets with score-line.
Upper stamp: 2.5 & logo (
Lower stamp: HMR & 2.5
4. Clinical Particulars
4.1 Therapeutic Indications
- Treatment of hypertension.
- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:
|
- Treatment of renal disease:
|
- Treatment of symptomatic heart failure.
|
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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