Posology : מינונים

4.2. Posology and method of administration
Posology
The absorption of Enalapril is not affected by food.
The dose should be individualized according to patient profile (see section 4.4) and blood pressure response.

Paediatric population
There is limited clinical trial experience of the use of Enalapril in hypertensive paediatric patients (see sections 4.4, 5.1 and 5.2).

Hypertension
The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient (see below). Enalapril 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.
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 is used in addition to diuretics and, where appropriate, digitalis or beta-blockers. The initial dose of Enalapril 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 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.

Table 1: Suggested Dosage Titration of Enalapril in Patients with Heart Failure/Asymptomatic Left Ventricular Dysfunction

Week                        Dose mg/day
Week 1                      Days 1 to 3: 2.5 mg/day1 in a single dose Days 4 to 7: 5 mg/day in two divided doses
Week 2                      10 mg/day in a single dose or in two divided doses
Weeks 3 and 4               20 mg/day in a single dose or in two divided doses
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Special precautions should be followed in patients with impaired renal function or taking diuretics (See section 4.4).

Blood pressure and renal function should be monitored closely both before and after starting treatment with Enalapril (see section 4.4) 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. The appearance of hypotension after the initial dose of Enalapril does not imply that hypotension will recur during chronic therapy with Enalapril 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.

Table 2: Dosage in Renal Insufficiency
Creatinine Clearance (CrCL)                        Initial Dose mL/min                                   mg/day
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