Ramipro Full Prescribing Information, Dosage & Side Effects

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Contents

Ramipril.

Description

Each tablet contains: Ramipril 2.5 mg, 5 mg & 10 mg.

Action

Pharmacology: Pharmacokinetics: Ramipril acts as a prodrug of the diacid ramiprilat, its active metabolite. Following oral administration at least 50 to 60% is absorbed. Ramipril is metabolized in the liver to ramiprilat; other metabolites are inactive. Peak plasma concentrations of ramiprilat are achieved 2 to 4 hours after an oral dose of ramipril. Ramiprilat is about 56% bound to plasma proteins. About 60% of an oral dose of ramipril of an oral dose of ramipril is excreted in the urine, the rest in the feces. The effective half-life for accumulation of ramipril is 13 to 17 hours following multiple doses of ramipril 5 to 10 mg, but it is much longer for doses of 1.25 to 2.5 mg daily. The clearance of ramiprilat is reduced in renal impairment.

Indications/Uses

Ramipril is an ACE inhibitor. It is used in the treatment of hypertension, heart failure and following myocardial infarction to improve survival in patients with clinical evidence of heart failure. It is also used to reduce the risk of cardiovascular events in patients with certain risk factors.

Dosage/Direction for Use

In the treatment of hypertension: the initial dose is 1.25 mg once daily. The usual maintenance is 2.5 mg to 5 mg daily, although up to 10 mg daily maybe required or as prescribed by the physician.
In the management of heart failure: the initial dose is 1.25 mg once daily. The usual maximum dose is 10 mg daily; doses of 2.5 mg or more daily may be taken to 1 or 2 divided doses. Or as prescribed by the physician.
For myocardial infarction: the usual the initial dose is 2.5 mg or more daily maybe taken to 1 or 2 divided doses. Or as prescribed by the physician.
For the prophylaxis of cardiovascular events: the initial dose is 2.5 mg once daily. The dose should be increased, if tolerated, to 5 mg once daily after 1 week, then to the usual maintenance dose of 10 mg once daily after further 3 weeks. Or as prescribed by the physician.
In patients with hypertension or recent myocardial infarction it may also be given in divided doses.

Special Precautions

Ramipril should not be used in patients with aortic stenosis or outflow tract obstruction. It should be noted that the elderly or patients with peripheral vascular diseases or generalized atherosclerosis may be at high risk because they may have clinically silent renovascular disease. Renal function should be assessed in all patients prior to administration of ACE inhibitors and should be monitored during therapy. Ramipril should be used with caution in patients with a history of idiopathic or hereditary angioedema. It should also not be used during pregnancy. Ramipril should not be administered to women who are breastfeeding.

Use In Pregnancy & Lactation

Ramipril should not be administered to women who are breastfeeding.

Adverse Reactions

The effects include hypotension, dizziness, fatigue, gastrointestinal disturbances, taste disturbances, persistent dry cough and other respiratory tract symptoms, skin rashes (including erythema multiforme and toxic epidermal necrolysis), angioedema, hypersensitivity reactions, renal impairment, hypokalemia, hyponatremia and blood disorders.
Other adverse effects reported with ACE inhibitors include chest pain, palpitations, tachycardia, stomatitis, abdominal pain, pancreatitis, hepatocellular injury or cholestatic jaundice, alopecia, muscle cramps, paraesthesias, mood and sleep disturbances and impotence.

View ADR Monitoring Form

Drug Interactions

The use of ACE inhibitors with potassium supplements, salt substitutes or diuretics (for example, spironolactone) that increase potassium in the blood may lead to excessive potassium levels. Potassium levels should be monitored whenever ACE inhibitors are used in combination with these drugs.

Storage

Store at temperatures not exceeding 30°C.

MIMS Class

ACE Inhibitors/Direct Renin Inhibitors

ATC Classification

C09AA05 - ramipril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.

Regulatory Classification

Presentation/Packing

Form

Ramipro tab 10 mg

Packing/Price

30's (P780/pack)

Form

Ramipro tab 2.5 mg

Packing/Price

30's (P450/pack)

Form

Ramipro tab 5 mg

Packing/Price

30's (P525/pack)

Ramipro

ramipril

Manufacturer:

InnoGen Pharmaceuticals

Distributor:

InnoGen Pharmaceuticals