Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa
Treatment of hypertension.
Treatment of heart failure: ALAPREN TABLETS is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients ALAPREN TABLETS improves symptoms, increases survival, and decreases the frequency of hospitalization.
Asymptomatic left ventricular dysfunction: In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction <35%), enalapril decreases the rate of development of overt heart failure and decreases the incidence of hospitalisation for heart failure.
ALAPREN TABLETS is not available in a 2,5 mg strength. Please use an alternative enalapril 2,5 mg product available on the market, Since food does not interfere with the absorption of ALAPREN TABLETS, the dose may be administered before, during or after meals.
The initial dose is 10 to 20 mg depending on the degree of hypertension and is given once daily. In mild hypertension the recommended initial dose is 10 mg daily. For other degrees of hypertension the initial dose is 20 mg daily. The usual maintenance dose is one 20 mg tablet taken once daily. The dosage should be adjusted according to the needs of the patient.
Symptomatic hypotension may occur following the initial dose of ALAPREN TABLETS; this is more likely in patients who are being treated currently with diuretics. Caution is recommended, therefore, since these patients may be volume or salt depleted. The diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with ALAPREN TABLETS. If this is not possible, the initial dose of enalapril should be low (5 mg or less) to determine the initial effect on the blood pressure. Dosage should then be adjusted according to the needs of the patient.
Therapy should be initiated with ALAPREN TABLETS in a dose of 2,5 mg. The hypotensive response to ALAPREN TABLETS may be greater in elderly patients.
In such patients the recommended starting dose of ALAPREN TABLETS is 2,5 mg once daily initiated under medical supervision to determine the initial effect on the blood pressure. It is important that therapy is initiated in hospital for patients with severe heart failure. The dose of ALAPREN TABLETS should be titrated gradually to a maintenance dose of 20 mg daily given as a single dose or two divided doses, according to the tolerability of the patient.
The dose titration of ALAPREN TABLETS should be performed over two to four weeks or more rapidly in the presence of residual signs and symptoms of heart failure. The patient’s blood pressure, renal function and serum potassium must be monitored closely both before and during treatment with ALAPREN TABLETS because hypotension and consequent renal failure have been reported. Patients who are treated with diuretics should have the diuretic dose reduced, if possible, before starting treatment with ALAPREN TABLETS. In case hypotension develops following the initial dose of ALAPREN TABLETS, this does not imply that hypotension will recur during chronic therapy with ALAPREN TABLETS and does not preclude continued use of ALAPREN TABLETS.
(See Section 4.4., Impaired Renal Function).
Generally the intervals between the administration of enalapril should be prolonged and/or the dosage reduced.
| Renal status | Creatinine Clearance (ml/min) | Initial Dose (mg/day) |
|---|---|---|
| Mild impairment | < 80 > 50 | 5 |
| Moderate impairment | < 50 > 30 | 2,5 |
Serum potassium also should be regularly monitored (see Section 4.4 and 4.5).
Oral use.
Limited data are available for overdosage in humans. The most prominent feature of overdosage is hypotension, six hours after ingestion of the tablets, as well as stupor.
Symptoms associated with overdosage of ALAPREN TABLETS may include circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.
The recommended treatment of overdosage with ALAPREN TABLETS is symptomatic and supportive. An intravenous infusion of 0,9% sodium chloride may be considered. If available, treatment with angiotensin II infusion and/or intravenous sympathomimetics may also be considered.
ALAPREN TABLETS may be removed from the general circulation by haemodialysis. Vital signs, serum electrolytes and creatinine concentrations should be monitored.
36 months.
Store at or below 25°C, protected from moisture.
ALAPREN 5 TABLETS: Carton containing 4 blister strips of 7 tablets in each blister.
ALAPREN 10 TABLETS: Carton containing 4 blister strips of 7 tablets in each blister.
ALAPREN 20 TABLETS: Carton containing 4 blister strips of 7 tablets in each blister.
No special requirements.
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