Enalapril Stella Dosage/Direction for Use

Administration: Oral use.
Dosage: The absorption of enalapril maleate is not affected by food.
The dose should be individualized according to patient profile and blood pressure response.
Paediatric population: There is limited clinical trial experience of the use of enalapril in hypertensive paediatric patients.
Hypertension: The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient (see as follows). Enalapril maleate is given once daily. In mild hypertension, the recommended initial dose is 5 to 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (e.g., renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 5 mg or lower is recommended in such patients and the initiation of treatment should take place under medical supervision.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with enalapril. A starting dose of 5 mg or lower is recommended in such patients. If possible, diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with enalapril maleate tablets. Renal function and serum potassium should be monitored.
The usual maintenance dose is 20 mg daily. The maximum maintenance dose is 40 mg daily.
Heart failure/asymptomatic left ventricular dysfunction: In the management of symptomatic heart failure, enalapril maleate is used in addition to diuretics and, where appropriate, digitalis or beta-blockers. The initial dose of enalapril maleate tablets in patients with symptomatic heart failure or asymptomatic left ventricular dysfunction is 2.5 mg^(**), and it should be administered under close medical supervision to determine the initial effect on the blood pressure. In the absence of, or after effective management of, symptomatic hypotension following initiation of therapy with enalapril maleate tablets in heart failure, the dose should be increased gradually to the usual maintenance dose of 20 mg, given in a single dose or two divided doses, as tolerated by the patient. This dose titration is recommended to be performed over a 2 to 4 week period. The maximum dose is 40 mg daily given in two divided doses.
Suggested dosage titration of enalapril maleate tablets in patients with heart failure/asymptomatic left ventricular dysfunction: See Table 1.

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Blood pressure and renal function should be monitored closely both before and after starting treatment with enalapril maleate tablets because hypotension and (more rarely) consequent renal failure have been reported. In patients treated with diuretics, the dose should be reduced if possible before beginning treatment with enalapril maleate tablets. The appearance of hypotension after the initial dose of enalapril maleate tablets does not imply that hypotension will recur during chronic therapy with enalapril maleate tablets and does not preclude continued use of the drug. Serum potassium and renal function also should be monitored.
Dosage in renal insufficiency: Generally, the intervals between the administration of enalapril should be prolonged and/or the dosage reduced.
Dosage in Renal Insufficiency: See Table 2.

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Enalaprilat is dialysable. Dosage on non-dialysis days should be adjusted depending on the blood pressure response.
Use in elderly: The dose should be in line with the renal function of the elderly patient.
Use in paediatrics: For patients who can swallow tablets, the dose should be individualised according to patient profile and blood pressure response. The recommended initial dose is 2.5 mg^(**) in patients 20 to < 50 kg and 5 mg in patients ≥ 50 kg. Enalapril maleate is given once daily. The dosage should be adjusted according to the needs of the patient to a maximum of 20 mg daily in patients 20 to < 50 kg and 40 mg in patients ≥ 50 kg.
Enalapril maleate tablets are not recommended in neonates and in paediatric patients with glomerular filtration rate < 30 ml/min/1.73 m², as no data are available.
^(**) Other preparation should be used for dose of 2.5 mg.