Generic

Ramipril

Indications

Ramipril indicated in the following cases:

• Hypertension; to lower blood pressure, as single-drug therapy or in combination with other antihypertensive agents.
• Congestive heart failure; also in combination with diuretics.
• Treatment of patients who- within the first few days after an acute myocardial infarction- have demonstrated clinical signs of congestive heart failure.
• Treatment of non-diabetic or diabetic overt glomerular or incipient nephropathy.
• Reduction in the risk of myocardial infarction, stroke, or cardiovascular death in patients with an increased cardiovascular risk, such as manifest coronary heart disease (with or without a history of myocardial infarction), a history of stroke, a history of peripheral vascular disease, or diabetes mellitus that is accompanied by at least one other cardiovascular risk factor (microalbuminuria, hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, smoking).

Pharmacology

Ramipril is an angiotensin converting enzyme (ACE) inhibitor. After being hydrolyzed to ramiprilat, it can block the conversion of angiotensin I to the vasoconstrictor angiotensin II. Therefore, the inhibition of ACE by ramipril leads to a decrease in plasma angiotensin II, which leads to a decrease in vasopressor activity and a decrease in aldosterone secretion. Therefore, ramipril exerts its antihypertensive activity. It can also effectively control heart failure and reduce the risk of death from stroke, heart attack, and cardiovascular events. It is long-lasting and well tolerated, so it can be used for long-term treatments.

Dosage & Administration

Dosage of Ramipril must be adjusted according to the patient tolerance and response.

Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.

Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.

Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.

Dosage in renal impairment:

• For patients with hypertension and renal impairment: The recommended initial dose is 1.25 mg Ramipril once daily. Subsequent dosage should be titrated according to individual tolerance and BP response, up to a maximum of 5 mg daily.
• For patients with heart failure and renal impairment: The recommended dose is 1.25 mg once daily. The dose may be increased to 1.25 mg twice daily and up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability.

Interaction

Combination with diuretics can cause severe hypotension. In addition, potassium-sparing diuretics can cause dangerous hyperkalemia. Concomitant lithium therapy may increase serum lithium concentration. Lowering blood pressure affects the ability to drive and use machinery, and alcohol can exacerbate this condition. NSAIDs can reduce the antihypertensive effect of ramipril and lead to impaired renal function.

Contraindications

Ramipril must not be used

• in patients with hypersensitivity to ramipril, to any other ACE inhibitor, or any of the excipients of Ramipril.
• in patients with a history of angioedema.
• concomitantly with sacubitril/valsartan therapy. Do not initiate Ramipril until sacubitril/valsartan is eliminated from the body. In case of switch from Ramipril to sacubitril/valsartan, do not start sacubitril/valsartan until Ramipril is eliminated from the body.
• in patients with haemodynamically relevant renal artery stenosis, bilateral or unilateral in the single kidney.
• in patients with hypotensive or haemodynamically unstable states.
• with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (creatinine clearance <60 ml/min).
• with angiotensin II receptor antagonists (AIIRAs) in patients with diabetic nephropathy.
• during pregnancy.

Concomitant use of ACE inhibitors and extracorporeal treatments leading to contact of blood with negatively charged surfaces must be avoided, since such use may lead to severe anaphylactoid reactions. Such extracorporeal treatments include dialysis or haemofiltration with certain high-fux (e.g. polyacrylonitril) membranes and low-density lipoprotein apheresis with dextran sulfate.

Side Effects

Ramipril is generally well tolerated. The most common side effects are dizziness, headache, fatigue and weakness. Other less common side effects include symptomatic hypotension, cough, nausea, vomiting, diarrhea, rash, urticaria, oliguria, anxiety, amnesia, etc. Angioedema, allergic reactions, and hyperkalemia are rarely reported.

Pregnancy & Lactation

Ramipril should not be taken during pregnancy. Therefore, pregnancy should be ruled out before starting treatment. In cases where treatment with ACE inhibitors is necessary, pregnancy should be avoided. If the patient intends to become pregnant, treatment with ACE inhibitors should be discontinued and replaced with another form of treatment. If the patient becomes pregnant during treatment, Ramipril should be replaced with an ACEI-free treatment plan as soon as possible. Otherwise, there is a risk of harm to the fetus. Ramipril is not recommended during breastfeeding.

Precautions & Warnings

Patients with renal insufficiency, hyperkalemia, hypotension, and liver insufficiency should use ramipril with caution.

Therapeutic Class

Angiotensin Converting Enzyme (ACE) Inhibitor

Storage Conditions

Store at 30° or below, away from light. Keep out of reach of children. Do not use after the expiration date. It can only be dispensed under the prescription of a registered doctor.

Pharmaceutical Name

Drug International Ltd.