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Ramipril information from DrugsUpdate  

See Available Brands of Ramipril in India

P - Contraindicated in pregnancy
L - Contraindicated in lactation

Ramipril (marketed as Ramipro by Westfield Pharma in the Philippines, marketed by Sanofi-Aventis as Tritace and by King Pharmaceuticals as Altace in the United States) is an angiotensin-converting enzyme (ACE) inhibitor, used to treat hypertension and congestive heart failure. ACE inhibitors lower the production of angiotensin II, therefore relaxing arterial muscles while at the same time enlarging the arteries, allowing the heart to pump blood more easily, and increasing blood flow due to more blood being pumped into and through larger passageways.

Pharmacodynamics

Single doses of Ramipril of 2.5 to 20 mg produce approximately 60 to 80% inhibition of ACE activity 4 hours after dosing with approximately 40 to 60% inhibition after 24 hours. Multiple oral doses of Ramipril of 2 mg or more cause plasma ACE activity to fall by more than 90% 4 hours after dosing, with over 80% inhibition of ACE activity remaining 24 hours after dosing. The more prolonged effect of even small multiple doses presumably reflects saturation of ACE binding sites by Ramiprilat and relatively slow release from those sites.

Pharmacokinetics

Ramipril is an ACE inhibitor which is metabolised into the active metabolite ramiprilat. It competitively inhibits angiotensin-converting enzyme (ACE) from converting angiotensin I to angiotensin II resulting in increased plasma renin activity and reduced aldosterone secretion. It also increases bradykinin levels. By these mechanisms, ramipril produces a hypotensive effect and a beneficial effect in CHF.

Absorption
50-60% is absorbed from the GI tract (oral); peak plasma concentrations after 2-4 hours (ramiprilat).

Distribution

Protein-binding: 56%.

Metabolism

Hepatic: Converted to ramiprilat.

Excretion
Via urine (60% of the dose), via faeces (remaining dose); 13-17 hours (elimination half-life), may be prolonged in renal impairment.

Ramipril Indications / Ramipril Uses

Information Not Available

Ramipril Adverse Reactions / Ramipril Side Effects

Nausea, vomiting, diarrhoea, dizziness, fatigue, headache, abdominal pain, cough. Rarely symptomatic hypotension. Angioneurotic oedema of face, lips, tongue, glottis and larynx, syncope, renal impairment, hypersensitivity reactions.

Potentially Fatal: Severe hypotension and renal failure, angioedema.

Precautions

Information Not Available

Special Precautions

Renal impairment, hypovolaemia, hyperkalaemia, valvular stenosis; before, during or immediately after anaesthesia. Severe resistant hypertension, elderly, peripheral vascular disease or generalised atherosclerosis. Monitor renal function before and during treatment. Use with caution in patients with history of idiopathic or hereditary angioedema. Regular monitoring of WBC in patients with vascular collagen disorders is recommended.

Other Drug Interactions

NSAIDs may increase risk of deterioration of renal function.

Potentially Fatal: Concomitant admin of diuretics may lead to serious hypotension. Severe hyperkalaemia may result when used with potassium-sparing diuretics, potasisum supplements and drugs that cause hyperkalaemia. May increase serum lithium concentration.

Other Interactions

Information Not Available

Dosage

Oral
Hypertension
Adult: Initially, 1.25 mg once daily given at bedtime. Maintenance: 2.5-5 mg daily as a single dose, up to 10 mg daily as needed.

CrCl (ml/min)    Dosage Recommendation
10-30               Initiate with 1.25 mg once daily. Max dose: 5 mg daily.
<10                  Initiate with 1.25 mg once daily. Max dose: 2.5 mg daily.
Hepatic impairment: Initiate with 1.25 mg once daily.

Oral
Heart failure
Adult: Initially, 1.25 mg once daily. Max dose: 10 mg daily. Doses ≥2.5 mg may be given in 2 divided doses.
Max Dosage: 10 mg daily in 1-2 divided doses.

CrCl (ml/min)    Dosage Recommendation
10-30               Initiate with 1.25 mg once daily. Max dose: 5 mg daily.
<10                  Initiate with 1.25 mg once daily. Max dose: 2.5 mg daily.
Hepatic impairment: Initiate with 1.25 mg once daily.

Oral

Post myocardial infarction
Adult: Initially, 2.5 mg bid increased after 2 days to 5 mg bid. Start treatment 3-10 days after infarction. Usual dose: 2.5-5 mg bid.

CrCl (ml/min)    Dosage Recommendation
10-30               Initiate with 1.25 mg once daily. Max dose: 5 mg daily.
<10                  Initiate with 1.25 mg once daily. Max dose: 2.5 mg daily.
Hepatic impairment: Initiate with 1.25 mg once daily.

Oral
Prophylaxis of cardiovascular events in high-risk patients
Adult: Initially, 2.5 mg once daily increased to 5 mg once daily after 1 wk if tolerated. Maintenance: 10 mg once daily after a further 3 weeks.

CrCl (ml/min)    Dosage Recommendation
10-30               Initiate with 1.25 mg once daily. Max dose: 5 mg daily.
<10                  Initate with 1.25 mg once daily. Max dose: 2.5 mg daily.
Hepatic impairment: Initiate with 1.25 mg once daily.

Food(before/after)

May be taken with or without food

List of Contraindications

Ramipril and Pregnancy

Contraindicated in pregnancy

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

In 2nd & 3rd trimesters.

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Ramipril and Lactation

Contraindicated in lactation

Ramipril and Children

Safety and efficacy not established

Ramipril and Geriatic

May show higher blood levels of active metabolite

Ramipril and Other Contraindications

Hypersensitivity, bilateral renal artery stenosis, or a single kidney with unilateral renal artery stenosis. Aortic stenosis or outflow tract obstruction. Pregnancy and lactation.

Storage

Information Not Available

Lab interference

Information Not Available

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