Ramoril 10

What is Ramoril?

Ramoril is an ACE inhibitor containing the generic Ramipril, manufactured by Incepta Pharmaceuticals Ltd. It is used to treat hypertension, congestive heart failure, and to reduce cardiovascular risk after myocardial infarction or in high-risk patients.

Indications

Hypertension, 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 increased cardiovascular risk, including manifest coronary heart disease, history of stroke, peripheral vascular disease, or diabetes mellitus with at least one other cardiovascular risk factor.

Pharmacology

Ramipril is an ACE inhibitor which, after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor angiotensin II. Inhibition of ACE results in decreased plasma angiotensin II, leading to decreased vasopressor activity and decreased aldosterone secretion, producing its antihypertensive effect. It is also effective in managing heart failure and reducing the risk of stroke, myocardial infarction, and cardiovascular death. It is long-acting and well tolerated, suitable for long-term therapy.

Dosage & Administration

Hypertension: In adults not receiving a diuretic, the usual initial dose is 1.25-2.5 mg once daily, adjusted no more rapidly than at 2-week intervals; usual maintenance dose is 2.5-20 mg daily as a single or 2 divided doses.
Congestive Heart Failure after MI: May be initiated as early as 2 days post-MI; initial dose 2.5 mg twice daily (reduce to 1.25 mg twice daily if hypotension occurs), titrated to a target of 5 mg twice daily.
Prevention of Major Cardiovascular Events: 2.5 mg once daily for week 1, 5 mg once daily for the following 3 weeks, then increased as tolerated to a maintenance dose of 10 mg once daily.
Renal Impairment: Hypertension with renal impairment: initial dose 1.25 mg once daily, up to a maximum of 5 mg daily. Heart failure with renal impairment: 1.25 mg once daily, may increase to a maximum of 2.5 mg twice daily.
Tablets should be swallowed with sufficient liquid, not chewed or crushed. May be taken before, during, or after a meal.

Interaction

Concomitant use with diuretics may cause serious hypotension, and with potassium-sparing diuretics, dangerous hyperkalemia. Lithium therapy may have increased serum concentration. NSAIDs may reduce the antihypertensive effect and cause deterioration of renal function. Alcohol may exacerbate BP-lowering effects.

Contraindications

Hypersensitivity to ramipril, any other ACE inhibitor, or excipients. History of angioedema. Concomitant use with sacubitril/valsartan. Haemodynamically relevant renal artery stenosis. Hypotensive or haemodynamically unstable states. Concomitant use with aliskiren in diabetic or moderate-to-severe renal impairment patients. Concomitant use with angiotensin II receptor antagonists in diabetic nephropathy. Pregnancy.

Side Effects

Generally well tolerated. Common: dizziness, headache, fatigue, asthenia. Less frequent: symptomatic hypotension, cough, nausea, vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia. Rare: angioneurotic oedema, anaphylactic reactions, hyperkalaemia.

Pregnancy & Lactation

Must not be taken during pregnancy; pregnancy must be excluded before starting treatment. If pregnancy occurs during treatment, Ramipril must be replaced as soon as possible with a non-ACE-inhibitor regimen. Not recommended during breastfeeding.

Precautions & Warnings

Use with caution in patients with impaired renal function, hyperkalaemia, hypotension, and impaired hepatic function. Elderly patients should consider a reduced initial dose of 1.25 mg daily. Hepatic impairment patients require close medical supervision with a maximum daily dose of 2.5 mg. Patients pretreated with a diuretic should generally start at 1.25 mg daily.

Overdose Effects

Overdose may cause excessive peripheral vasodilatation with marked hypotension, shock, bradycardia, electrolyte disturbances, and renal failure. Management includes gastric lavage, adsorbents, sodium sulfate (within first 30 minutes), and for hypotension, α1-adrenergic agonists with volume and salt substitution.

Therapeutic Class

Angiotensin-Converting Enzyme (ACE) Inhibitor

Storage Conditions

Store at 30°C or below, protected from light. Keep out of reach of children.