Renite-5 XL/Renite XL

Enalapril maleate.

Each tablet contains: Enalapril maleate B.P. 5 mg or 10 mg.

Pharmacology: Pharmacokinetics: Enalapril acts as a prodrug of the diacid enalaprilat, its active form, which is poorly absorbed by mouth. Following oral administration about 60% of a dose of Enalapril is absorbed from the gastrointestinal tract and peak plasma concentrations are achieved within about 1 hour. Enalapril is extensively hydrolysed in the liver to Enalapril; peak plasma concentrations of Enalapril are achieved 3 to 4 hours after an oral dose of Enalapril. Enalapril is 50 to 60% bound to plasma proteins. Following an oral dose, Enalapril is excreted in the urine and in faeces, as enalapril and unchanged drug, with the urinary route predominating; more than 90% of an intravenous dose of enalaprilat is excreted in the urine. The elimination of Enalapril is multiphasic but the effective half-life for accumulation following multiple doses of Enalapril is reported to be about 11 hours in patients with normal renal function. Enalapril is removed by haemodialysis and by peritoneal dialysis.

Used in the treatment of hypertension and heart failure. It is also given prophylactically to patients with asymptomatic left ventricular dysfunction to delay the onset of symptomatic heart failure and also used in patient with left ventricular dysfunction to reduce the incidence of coronary ischemic events including myocardial infarction.

Hypertension: Initial dose of 5 mg.
Patient with renal impairment or those who are receiving diuretic: 2.5 mg daily.
Usual Maintenance dose: 10 mg to 20 mg once daily.
Severe Hypertension: 40 mg daily.
Heart failure or asymptomatic left ventricular dysfunction: 2.5 mg daily.
Or as prescribed by the physician.

Known hypersensitivity to the active substance or to any of the excipients.

Enalapril Maleate should not be used in patients with aortic stenosis or out flow tract obstruction.
Use in Pregnancy: Enalapril is contraindicated in pregnancy and in women who can become pregnant. If a woman becomes pregnant during treatment, Enalapril should be discontinued.

Use in Pregnancy: Enalapril is contraindicated in pregnancy and in women who can become pregnant. If a woman becomes pregnant during treatment, Enalapril should be discontinued.

The most common adverse effects are hypotension, dizziness, fatigue, headache, nausea, and other gastrointestinal disorder.

Renite XL: Excessive hypotension may occur when ACE Inhibitors are used with diuretics, other antihypertensives or other agents including alcohol, that lower blood pressure. An additive hyperkalaemic effect is possible in patients receiving ACE Inhibitors with potassium-sparing diuretics, potassium supplements (including potassium containing salt substitutes) or other drugs that can cause hyperkalaemia (such as ciclosporin or indomethacin) and serum potassium concentrations should be monitored. Potassium sparing diuretics and potassium supplements should generally be stopped before starting ACE inhibitors in patients with heart failure. However ACE inhibitor therapy does not obviate the possible need for potassium supplementation in patients receiving potassium-wasting diuretics and potassium concentrations should also be monitored in these patients. The adverse effects of ACE inhibitors on the kidneys may be potentiated by other drugs such as NSAID's that can affect renal function.

Store at temperatures not exceeding 30°C.

ACE Inhibitors/Direct Renin Inhibitors

C09AA02 - enalapril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.

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