Fenitoina Denver Farma may be available in the countries listed below.
Phenytoin sodium salt (a derivative of Phenytoin) is reported as an ingredient of Fenitoina Denver Farma in the following countries:
International Drug Name Search
Isairon may be available in the countries listed below.
Chondroitin Polysulfate iron complex (a derivative of Chondroitin Polysulfate) is reported as an ingredient of Isairon in the following countries:
International Drug Name Search
Efotinon may be available in the countries listed below.
Etilefrine hydrochloride (a derivative of Etilefrine) is reported as an ingredient of Efotinon in the following countries:
International Drug Name Search
Chrono-Indocid may be available in the countries listed below.
Indometacin is reported as an ingredient of Chrono-Indocid in the following countries:
International Drug Name Search
Gonadotropine chorionique may be available in the countries listed below.
Gonadotropine chorionique (DCF) is also known as Chorionic Gonadotrophin (Rec.INN)
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Rocefin may be available in the countries listed below.
Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of Rocefin in the following countries:
International Drug Name Search
Ibuprofen Helvepharm may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Ibuprofen Helvepharm in the following countries:
International Drug Name Search
Paracetamol PharmaMatch may be available in the countries listed below.
Paracetamol is reported as an ingredient of Paracetamol PharmaMatch in the following countries:
International Drug Name Search
Flacidine may be available in the countries listed below.
Rocuronium Bromide is reported as an ingredient of Flacidine in the following countries:
International Drug Name Search
Colitofalk Granu-Box may be available in the countries listed below.
Mesalazine is reported as an ingredient of Colitofalk Granu-Box in the following countries:
International Drug Name Search
Ciproflomed may be available in the countries listed below.
Ciprofloxacin is reported as an ingredient of Ciproflomed in the following countries:
International Drug Name Search
In the US, Indinavir (indinavir systemic) is a member of the drug class protease inhibitors and is used to treat HIV Infection, Nonoccupational Exposure and Occupational Exposure.
US matches:
Rec.INN
J05AE02
0150378-17-9
C36-H47-N5-O4
613
Antiviral agent, HIV protease inhibitor
(αR,þS,2S)-α-Benzyl-2-(tert-butylcarbamoyl)-þ-hydroxy-N-[(1S,2R)-2-hydroxy-1-indanyl]-4-(3-pyridylmethyl)-1-piperazinevaleramide
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| 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 |
Tiapride Hydrochloride may be available in the countries listed below.
Tiapride Hydrochloride (BANM, JAN) is also known as Tiapride (Rec.INN)
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Talosin may be available in the countries listed below.
Citalopram is reported as an ingredient of Talosin in the following countries:
International Drug Name Search
Metanor may be available in the countries listed below.
Flupirtine maleate (a derivative of Flupirtine) is reported as an ingredient of Metanor in the following countries:
International Drug Name Search
Carboplatino Sidus may be available in the countries listed below.
Carboplatin is reported as an ingredient of Carboplatino Sidus in the following countries:
International Drug Name Search
Azicid may be available in the countries listed below.
Azithromycin is reported as an ingredient of Azicid in the following countries:
International Drug Name Search
Biherpan may be available in the countries listed below.
Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Biherpan in the following countries:
Zinc Sulfate is reported as an ingredient of Biherpan in the following countries:
International Drug Name Search
Atarin may be available in the countries listed below.
Amantadine hydrochloride (a derivative of Amantadine) is reported as an ingredient of Atarin in the following countries:
International Drug Name Search
Acetylcysteine Apotex may be available in the countries listed below.
Acetylcysteine is reported as an ingredient of Acetylcysteine Apotex in the following countries:
International Drug Name Search
ratio-Gentamicin may be available in the countries listed below.
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of ratio-Gentamicin in the following countries:
International Drug Name Search
Minedon may be available in the countries listed below.
Glucosamine sulfate sodium chloride (a derivative of Glucosamine) is reported as an ingredient of Minedon in the following countries:
International Drug Name Search
Acépromazine may be available in the countries listed below.
Acépromazine (DCF) is also known as Acepromazine (Rec.INN)
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Raquiferol may be available in the countries listed below.
Ergocalciferol is reported as an ingredient of Raquiferol in the following countries:
International Drug Name Search
Motilon may be available in the countries listed below.
Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Motilon in the following countries:
International Drug Name Search
Inflamyl may be available in the countries listed below.
Mefenamic Acid is reported as an ingredient of Inflamyl in the following countries:
International Drug Name Search
Pulmicort EuropharmaDK may be available in the countries listed below.
Budesonide is reported as an ingredient of Pulmicort EuropharmaDK in the following countries:
International Drug Name Search
Laevolac-Lactulose may be available in the countries listed below.
Lactulose is reported as an ingredient of Laevolac-Lactulose in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Clioquinol is reported as an ingredient of Rheaform in the following countries:
International Drug Name Search
Kofen may be available in the countries listed below.
Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Kofen in the following countries:
International Drug Name Search
Magnesium 1A Pharma may be available in the countries listed below.
Magnesium Oxide light (a derivative of Magnesium Oxide) is reported as an ingredient of Magnesium 1A Pharma in the following countries:
International Drug Name Search
Griséfuline may be available in the countries listed below.
Griseofulvin is reported as an ingredient of Griséfuline in the following countries:
International Drug Name Search
Indophtal may be available in the countries listed below.
Indometacin is reported as an ingredient of Indophtal in the following countries:
International Drug Name Search
BAN
R02AA12
0000136-77-6
C12-H18-O2
194
Anthelmintic
1,3-Benzenediol, 4-hexyl-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
In the US, Mycobutin (rifabutin systemic) is a member of the drug class rifamycin derivatives and is used to treat Mycobacterium avium-intracellulare - Prophylaxis, Mycobacterium avium-intracellulare - Treatment, Tuberculosis - HIV Positive and Tuberculosis - Prophylaxis.
US matches:
UK matches:
Rifabutin is reported as an ingredient of Mycobutin in the following countries:
Rifampicin is reported as an ingredient of Mycobutin in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Migraneitor may be available in the countries listed below.
Sumatriptan is reported as an ingredient of Migraneitor in the following countries:
International Drug Name Search
Biocanispot may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Imidacloprid is reported as an ingredient of Biocanispot in the following countries:
International Drug Name Search
Tobramisona may be available in the countries listed below.
Tobramycin is reported as an ingredient of Tobramisona in the following countries:
International Drug Name Search
Arimun Synoral may be available in the countries listed below.
Ciclosporin is reported as an ingredient of Arimun Synoral in the following countries:
International Drug Name Search
Chemilon Antiseptic Solution may be available in the countries listed below.
Cetrimide is reported as an ingredient of Chemilon Antiseptic Solution in the following countries:
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Chemilon Antiseptic Solution in the following countries:
International Drug Name Search
Haemato-folin may be available in the countries listed below.
Calcium Folinate is reported as an ingredient of Haemato-folin in the following countries:
International Drug Name Search
Alusulin may be available in the countries listed below.
Sucralfate is reported as an ingredient of Alusulin in the following countries:
International Drug Name Search
Trimductal may be available in the countries listed below.
Trimetazidine dihydrochloride (a derivative of Trimetazidine) is reported as an ingredient of Trimductal in the following countries:
International Drug Name Search
Conclyte-K1 may be available in the countries listed below.
Potassium Chloride is reported as an ingredient of Conclyte-K1 in the following countries:
International Drug Name Search
In the US, Promethazine DM (dextromethorphan/promethazine systemic) is a member of the drug class upper respiratory combinations and is used to treat Cold Symptoms, Cough and Hay Fever.
US matches:
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Promethazine DM in the following countries:
Promethazine hydrochloride (a derivative of Promethazine) is reported as an ingredient of Promethazine DM in the following countries:
International Drug Name Search
Acido Alendronico Edigen may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Acido Alendronico Edigen in the following countries:
International Drug Name Search
Gloryskin may be available in the countries listed below.
Bifonazole is reported as an ingredient of Gloryskin in the following countries:
International Drug Name Search
B12 1000 Plus Selenium may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Hydroxocobalamin is reported as an ingredient of B12 1000 Plus Selenium in the following countries:
Sodium Selenate is reported as an ingredient of B12 1000 Plus Selenium in the following countries:
International Drug Name Search
Tramadol Ranbaxy may be available in the countries listed below.
Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Tramadol Ranbaxy in the following countries:
International Drug Name Search
Roxine may be available in the countries listed below.
Dequalinium Chloride is reported as an ingredient of Roxine in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Dichlorophen is reported as an ingredient of L.K. Worming Capsules For Dogs in the following countries:
Toluene is reported as an ingredient of L.K. Worming Capsules For Dogs in the following countries:
International Drug Name Search
Flupamid may be available in the countries listed below.
Indapamide is reported as an ingredient of Flupamid in the following countries:
International Drug Name Search
Eritromed may be available in the countries listed below.
Erythromycin estolate (a derivative of Erythromycin) is reported as an ingredient of Eritromed in the following countries:
Erythromycin lactobionate (a derivative of Erythromycin) is reported as an ingredient of Eritromed in the following countries:
International Drug Name Search
Elisor may be available in the countries listed below.
Pravastatin is reported as an ingredient of Elisor in the following countries:
Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of Elisor in the following countries:
International Drug Name Search
Gastrex may be available in the countries listed below.
Dimeticone is reported as an ingredient of Gastrex in the following countries:
Lansoprazole is reported as an ingredient of Gastrex in the following countries:
International Drug Name Search
Localone may be available in the countries listed below.
Salicylic Acid is reported as an ingredient of Localone in the following countries:
Triamcinolone 16α,17α-acetonide (a derivative of Triamcinolone) is reported as an ingredient of Localone in the following countries:
International Drug Name Search
Remycin may be available in the countries listed below.
Doxycycline is reported as an ingredient of Remycin in the following countries:
Doxycycline hyclate (a derivative of Doxycycline) is reported as an ingredient of Remycin in the following countries:
Doxycycline hydrochloride (a derivative of Doxycycline) is reported as an ingredient of Remycin in the following countries:
International Drug Name Search
Edetate Trisodium may be available in the countries listed below.
Edetate Trisodium (USAN) is also known as Edetic Acid (Rec.INN)
International Drug Name Search
Glossary
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Avascare may be available in the countries listed below.
Atorvastatin calcium (a derivative of Atorvastatin) is reported as an ingredient of Avascare in the following countries:
International Drug Name Search
Cytarabine DBL may be available in the countries listed below.
Cytarabine is reported as an ingredient of Cytarabine DBL in the following countries:
International Drug Name Search
Pentoxifylline PCH may be available in the countries listed below.
Pentoxifylline is reported as an ingredient of Pentoxifylline PCH in the following countries:
International Drug Name Search
Co-Bisoprolol-Ratiopharm may be available in the countries listed below.
Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Co-Bisoprolol-Ratiopharm in the following countries:
Hydrochlorothiazide is reported as an ingredient of Co-Bisoprolol-Ratiopharm in the following countries:
International Drug Name Search
Ecolint may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Niclosamide is reported as an ingredient of Ecolint in the following countries:
International Drug Name Search
0001306-23-6
CdS
144
Dermatological agent: Antiseborrheic
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
In the US, Janumet (metformin/sitagliptin systemic) is a member of the drug class antidiabetic combinations and is used to treat Diabetes, Type 2.
US matches:
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Janumet in the following countries:
Sitagliptin phosphate hydrate (a derivative of Sitagliptin) is reported as an ingredient of Janumet in the following countries:
International Drug Name Search
Indapamida Generis may be available in the countries listed below.
Indapamide is reported as an ingredient of Indapamida Generis in the following countries:
International Drug Name Search
In the US, Aclasta (zoledronic acid systemic) is a member of the drug class bisphosphonates and is used to treat Hypercalcemia of Malignancy, Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Osteoporosis and Paget's Disease.
US matches:
UK matches:
Zoledronic Acid is reported as an ingredient of Aclasta in the following countries:
Zoledronic Acid monohydrate (a derivative of Zoledronic Acid) is reported as an ingredient of Aclasta in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
In some countries, this medicine may only be approved for veterinary use.
Progesterone is reported as an ingredient of Eazi Breed CIDR in the following countries:
International Drug Name Search
Rumicox may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Decoquinate is reported as an ingredient of Rumicox in the following countries:
International Drug Name Search
Folinate de calcium Dakota Pharm may be available in the countries listed below.
Calcium Folinate is reported as an ingredient of Folinate de calcium Dakota Pharm in the following countries:
International Drug Name Search
Actonel plus Calcium may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Actonel plus Calcium in the following countries:
Risedronic Acid monosodium (a derivative of Risedronic Acid) is reported as an ingredient of Actonel plus Calcium in the following countries:
International Drug Name Search
Ticlopidin-Puren may be available in the countries listed below.
Ticlopidine hydrochloride (a derivative of Ticlopidine) is reported as an ingredient of Ticlopidin-Puren in the following countries:
International Drug Name Search
Medetomidine Hydrochloride may be available in the countries listed below.
Medetomidine Hydrochloride (USAN) is also known as Medetomidine (Rec.INN)
International Drug Name Search
Glossary
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Levovid may be available in the countries listed below.
Levofloxacin is reported as an ingredient of Levovid in the following countries:
International Drug Name Search
Rec.INN
0017289-49-5
C9-H15-N3
165
Analgesic, antipyretic and anti-inflammatory agent
Non-steroidal anti-inflammatory drug, NSAID
2H-Indazole-3-amine, 4,5,6,7-tetrahydro-N,2-dimethyl-
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Proxidol may be available in the countries listed below.
Naproxen is reported as an ingredient of Proxidol in the following countries:
Naproxen sodium salt (a derivative of Naproxen) is reported as an ingredient of Proxidol in the following countries:
International Drug Name Search
Brovicton may be available in the countries listed below.
Itraconazole is reported as an ingredient of Brovicton in the following countries:
International Drug Name Search
Trimidura may be available in the countries listed below.
Trimipramine maleate (a derivative of Trimipramine) is reported as an ingredient of Trimidura in the following countries:
International Drug Name Search
Festal N may be available in the countries listed below.
Pancreatin is reported as an ingredient of Festal N in the following countries:
International Drug Name Search
Isoniazida Cipa may be available in the countries listed below.
Isoniazid is reported as an ingredient of Isoniazida Cipa in the following countries:
International Drug Name Search
Cefa-Tabs may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cefadroxil is reported as an ingredient of Cefa-Tabs in the following countries:
International Drug Name Search
Fedip retard may be available in the countries listed below.
Nifedipine is reported as an ingredient of Fedip retard in the following countries:
International Drug Name Search
Parox may be available in the countries listed below.
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Parox in the following countries:
International Drug Name Search
Topiramat Heumann may be available in the countries listed below.
Topiramate is reported as an ingredient of Topiramat Heumann in the following countries:
International Drug Name Search
Lenoxin may be available in the countries listed below.
Digoxin is reported as an ingredient of Lenoxin in the following countries:
International Drug Name Search
Panzer may be available in the countries listed below.
Omeprazole is reported as an ingredient of Panzer in the following countries:
International Drug Name Search
Gabapentine Zydus may be available in the countries listed below.
Gabapentin is reported as an ingredient of Gabapentine Zydus in the following countries:
International Drug Name Search
Pasetocin may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Pasetocin in the following countries:
International Drug Name Search
Losartan Helvepharm may be available in the countries listed below.
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Losartan Helvepharm in the following countries:
International Drug Name Search
Azulina Llorens may be available in the countries listed below.
Tetryzoline hydrochloride (a derivative of Tetryzoline) is reported as an ingredient of Azulina Llorens in the following countries:
International Drug Name Search
Apomorfina L.CH. may be available in the countries listed below.
Apomorphine is reported as an ingredient of Apomorfina L.CH. in the following countries:
International Drug Name Search
Ambrol may be available in the countries listed below.
Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Ambrol in the following countries:
International Drug Name Search
Paroxetin-Isis may be available in the countries listed below.
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Paroxetin-Isis in the following countries:
International Drug Name Search
Lamotrigine EG may be available in the countries listed below.
Lamotrigine is reported as an ingredient of Lamotrigine EG in the following countries:
International Drug Name Search
Lergibrumizol may be available in the countries listed below.
Astemizole is reported as an ingredient of Lergibrumizol in the following countries:
International Drug Name Search
Amoxicilline Biogaran may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilline Biogaran in the following countries:
International Drug Name Search
Etaxene may be available in the countries listed below.
Somatostatin is reported as an ingredient of Etaxene in the following countries:
International Drug Name Search
Aliviodol may be available in the countries listed below.
Meloxicam is reported as an ingredient of Aliviodol in the following countries:
International Drug Name Search
Amrinone Qilu may be available in the countries listed below.
Amrinone is reported as an ingredient of Amrinone Qilu in the following countries:
International Drug Name Search
Indapamid-Mepha may be available in the countries listed below.
Indapamide hemihydrate (a derivative of Indapamide) is reported as an ingredient of Indapamid-Mepha in the following countries:
International Drug Name Search
Fluoxetina Pharmagenus may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetina Pharmagenus in the following countries:
International Drug Name Search
Inderm may be available in the countries listed below.
Erythromycin is reported as an ingredient of Inderm in the following countries:
International Drug Name Search
Coronamole may be available in the countries listed below.
Dipyridamole is reported as an ingredient of Coronamole in the following countries:
International Drug Name Search
Galastop may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cabergoline is reported as an ingredient of Galastop in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
0000846-48-0
C19-H26-O2
286
Anabolic
Androgen
Androsta-1,4-dien-3-one, 17-hydroxy-, (17ß)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Betagen 0.5 may be available in the countries listed below.
Levobunolol hydrochloride (a derivative of Levobunolol) is reported as an ingredient of Betagen 0.5 in the following countries:
International Drug Name Search
Moxilanic may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Moxilanic in the following countries:
International Drug Name Search
Morphine HCl EG may be available in the countries listed below.
Morphine hydrochloride (a derivative of Morphine) is reported as an ingredient of Morphine HCl EG in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Diethylcarbamazine citrate (a derivative of Diethylcarbamazine) is reported as an ingredient of Filaribits in the following countries:
Oxibendazole is reported as an ingredient of Filaribits in the following countries:
International Drug Name Search
Tiapridex may be available in the countries listed below.
Tiapride hydrochloride (a derivative of Tiapride) is reported as an ingredient of Tiapridex in the following countries:
International Drug Name Search
Rodizim may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Rodizim in the following countries:
International Drug Name Search
Marcain may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
UK matches:
Bupivacaine hydrochloride (a derivative of Bupivacaine) is reported as an ingredient of Marcain in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Ramipril 5 mg Tablets
Each tablet contains 5 mg ramipril.
Excipients:
Each tablet contains 21.7 mg lactose monohydrate.
For a full list of excipients, see Section 6.1
Tablet
Pale pink coloured mottled, flat faced bevel edged oblong uncoated tablet debossed with “H” and “19” on either side of the scoreline on one side and scoreline on other side. The tablet can be divided into two equal halves.
- Treatment of hypertension
- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:
• manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or
• diabetes with at least one cardiovascular risk factor (see section 5.1).
- Treatment of renal disease:
• Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria,
• Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1).
• 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.
Oral use.
This strength is not suitable for dosages below 2.5mg
For doses < 2.5 mg/day Ramipril is not suitable. Other medicinal products of ramipril in adequate strength are available.
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 1.25mg 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 10mg 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.
• Hypersensitivity to ramipril, 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.
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.
This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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.
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.
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.
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.
|
|
|
|
| |
|
| ||||
|
|
|
| ||
|
|
|
|
| |
|
|
| |||
|
| ||||
|
|
| |||
|
|
|
|
| |
|
| ||||
|
|
|
|
|
|
|
|
| |||
|
|
|
| ||
|
|
|
|
| |
|
|
|
| ||
|
| ||||
|
|
|
| ||
|
|
| |||
|
|
|
|
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.
Pharmacotherapeutic group: ACE inhibitors, plain, ATC Code: C09A A05
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
|
|
|
| |
|
| |||
|
|
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The MICRO-HOPE study, a predefined substudy from HOPE, investigated the effect of the addition of ramipril 10 mg to the current medical regimen versus placebo in 3,577 patients at least
The primary analysis showed that 117 (6.5 %) participants on ramipril and 149 (8.4 %) on placebo developed overt nephropathy, which corresponds to a RRR 24 %; 95 % CI [3-40], p = 0.027.
The REIN study, a multicenter randomized, double-blind parallel group, placebo-controlled study aimed at assessing the effect of treatment with ramipril on the rate of decline of glomerular function rate (GFR) in 352 normotensive or hypertensive patients (18-70 years old) suffering from mild (i.e. mean urinary protein excretion > 1 and < 3 g/24 h) or severe proteinuria (
The main analysis of patients with the most severe proteinuria (stratum prematurely disrupted due to benefit in ramipril group) showed that the mean rate of GFR decline per month was lower with ramipril than with placebo; -0.54 (0.66) vs. -0.88 (1.03) ml/min/month, p = 0.038. The intergroup difference was thus 0.34 [0.03-0.65] per month, and around 4 ml/min/year; 23.1 % of the patients in the ramipril group reached the combined secondary endpoint of doubling of baseline serum creatinine concentration and/or end-stage renal disease (ESRD) (need for dialysis or renal transplantation) vs. 45.5 % in the placebo group (p = 0.02).
Secondary prevention after acute myocardial infarction
The AIRE study included more than 2,000 patients with transient/persistent clinical signs of heart failure after documented myocardial infarction. The ramipril treatment was started 3 to 10 days after the acute myocardial infarction. The study showed that after an average follow-up time of 15 months the mortality in ramipril-treated patients was 16.9 % and in the placebo treated patients was 22.6 %. This means an absolute mortality reduction of 5.7 % and a relative risk reduction of 27 % (95 % CI [11-40 %]).
Pharmacokinetics and Metabolism
Absorption
Following oral administration ramipril is rapidly absorbed from the gastrointestinal tract: peak plasma concentrations of ramipril are reached within one hour. Based on urinary recovery, the extent of absorption is at least 56 % and is not significantly influenced by the presence of food in the gastrointestinal tract. The bioavailability of the active metabolite ramiprilat after oral administration of 2.5 mg and 5 mg ramipril is 45 %.
Peak plasma concentrations of ramiprilat, the sole active metabolite of ramipril are reached 2-4 hours after ramipril intake. Steady state plasma con
