Enalapril maleate
Visa No.: 893110312823
Product: Erilcar 5
API: Enalapril maleate
Product Category: Cardiovascular & Metabolism
Version approved leaflet: 406/QĐ-QLD_19/09/2017_159
INDICATIONS
• Treatment of hypertension.
• Treatment of symptomatic heart failure.
• Prevention of heart failure symptoms in patients with left ventricular dysfunction.
DOSAGE AND ADMINISTRATION
Dosage
Oral absorption of enalapril is not affected by food. Dosage should be inpidualized according to the patient’s condition and blood pressure response.
Pediatric population:
Clinical experience with enalapril in children with hypertension is limited.
Hypertension:
The usual initial dose is 5 mg to a maximum of 20 mg once daily, depending on the severity of hypertension and the patient’s clinical condition. Enalapril should be administered once daily.
Mild hypertension: The recommended initial dose is 5–10 mg/day. Patients with marked activation of the renin–angiotensin–aldosterone system (e.g. renovascular hypertension, salt depletion and/or volume depletion, decompensated heart failure, or severe hypertension) may experience excessive hypotension after the initial dose. An initial dose of 5 mg or lower is recommended in these patients, and treatment initiation should be under medical supervision.
Prior treatment with high-dose diuretics may result in volume depletion and an increased risk of hypotension when initiating enalapril. An initial dose of 5 mg or lower is recommended. Where possible, diuretics should be discontinued 2–3 days before starting enalapril. Renal function and serum potassium should be monitored.
The usual maintenance dose is 20 mg/day, with a maximum dose of 40 mg/day.
Heart failure / asymptomatic left ventricular dysfunction:
For the management of heart failure symptoms, enalapril is used as adjunctive therapy with diuretics and, where appropriate, with digitalis or beta-blockers. The initial dose in patients with symptomatic heart failure or asymptomatic left ventricular dysfunction is 2.5 mg (using an appropriate tablet strength) and should be administered under medical supervision to assess the initial effect on blood pressure.
In the absence of symptomatic hypotension after initiation or once heart failure is adequately controlled, the dose should be gradually increased to the usual maintenance dose of 20 mg once daily or 20 mg in two pided doses, depending on patient tolerance. Dose titration should be carried out over 2–4 weeks. The maximum daily dose is 40 mg, given in two pided doses.
Table 1: Recommended dose titration of enalapril in patients with heart failure / asymptomatic left ventricular dysfunction
| Week | Dose (mg/day) |
| Week 1 | Day 1 - 3: 2.5 mg once daily* (preferably under close supervision in patients receiving diuretics) Day 4 - 7: 5mg daily, in two pided doses. |
| Week 2 | 10 mg/day, once daily or in 2 pided doses |
| Week 3 & 4 | 20 mg/day, once daily or in 2 pided doses. |
* Use tablets of an appropriate strength.
Blood pressure and renal function should be closely monitored before and after initiation of enalapril, as cases of hypotension and subsequent renal impairment have been reported (less frequently). In patients receiving diuretics, the diuretic dose should be reduced if possible before starting enalapril. Occurrence of hypotension after the initial dose does not indicate that it will recur during long-term treatment and is not a reason to discontinue therapy. Serum potassium levels and renal function should also be closely monitored.
Renal impairment: In general, the dosing interval should be extended or the dose reduced
Table 2. Dosage in patients with renal impairment
| Creatinine clearance (ml/min) | Initial dose (mg/day) |
| 30 - 80 | 5 - 10 |
| 10 - 30 | 2,5* |
| ≤ 10 | 2.5* on dialysis days. Enalapril is removed by hemodialysis. The dose on non-dialysis days should be adjusted according to blood pressure response. |
* Use tablets of an appropriate strength.
Elderly: Dose adjustment should be made according to renal function..
Children: For children able to swallow tablets, the dose should be inpidualized according to clinical condition and blood pressure response. The recommended initial dose is:
• Children 20 kg to < 50 kg: 2.5 mg once daily (using an appropriate tablet strength).
• Children ≥ 50 kg: 5 mg once daily.
Dose may be adjusted according to patient needs, up to a maximum of:
• Children 20 kg to < 50 kg: 20 mg/day.
• Children ≥ 50 kg: 40 mg/day.
Enalapril is not recommended in neonates and in pediatric patients with a glomerular filtration rate < 30 mL/min/1.73 m².
CONTRAINDICATIONS
- Hypersensitivity to enalapril or any excipients of the product.
- History of angioedema associated with ACE inhibitor therapy.
- Hereditary or idiopathic angioedema.
- Pregnancy during the second and third trimesters.
- Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m²).
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.
