Enalapril maleate
Visa No.: 893110312723
Product: Erilcar 10
API: Enalapril maleate
Product Category: Cardiovascular & Metabolism
Version approved leaflet: 10892e/QLD - ĐK_19/03/2025
INDICATIONS
Hypertension: Enalapril is indicated for the treatment of mild to severe hypertension. It may be used alone or in combination with other antihypertensive agents.
Congestive heart failure: Enalapril is commonly used in combination with cardiac glycosides, diuretics, & beta-receptor blockers for the treatment of symptomatic congestive heart failure.
Prevention of myocardial ischemic episodes and symptoms of heart failure in patients with left ventricular dysfunction.
Diabetic nephropathy (with or without hypertension).
Progressive chronic renal failure..
DOSAGE AND ADMINISTRATION
The dose of enalapril maleate should be adjusted according to the patient’s tolerance and clinical response. When initiating enalapril therapy, attention should be paid to the risk of hypotension. If the patient is receiving diuretic therapy, the diuretic should be discontinued, if possible, 2–3 days before starting enalapril If blood pressure is not adequately controlled with an ACE inhibitor alone, the diuretic may be cautiously reintroduced. If the diuretic cannot be discontinued in patients starting ACE inhibitor therapy, an initial dose of 2.5 mg enalapril should be administered in adults to determine the extent of the hypotensive effect for at least 2 hours and until blood pressure has stabilized for at least an additional hour.
Hypertension: Not receiving diuretics.
Adult: Usual initial dose: 2.5 mg/day.
Children from 1 month to 16 years of age: 0.08 mg/kg/day, up to a maximum of 5 mg.
Dosage should be adjusted according to the patient’s response. If blood pressure control is inadequate at the end of the dosing interval with once-daily administration, an increase in dose or pision of the daily dose into two administrations may be considered.
As blood pressure reduction may be gradual, the dose of enalapril is usually adjusted at intervals of 2–4 weeks if necessary.
The usual maintenance dose in adults is 10–40 mg/day, administered in 1–2 pided doses.
Enalapril doses exceeding 0.58 mg/kg or above 40 mg have not been studied in children.
If blood pressure is not adequately controlled with enalapril monotherapy, a diuretic may be added.
Congestive Heart Failure: Treatment should be initiated in hospital due to the risk of severe hypotension. Low-dose ACE inhibitor therapy should not be initiated in patients with hypotension or cardiogenic shock requiring vasopressor infusion; once the patient is stabilized, reassessment is required before treatment. Patients with severe heart failure with or without renal impairment should be closely monitored for renal function and serum potassium during the first 2 weeks of therapy and whenever the dose is increased or a diuretic is added. Initiating enalapril at a low dose and reducing the dose of concomitant diuretics may reduce the risk of initial hypotension. The initial enalapril dose in heart failure has not been definitively established.
Symptoms of congestive heart failure may improve within 48 hours after initiation of ACE inhibitor therapy in some patients; however, clinical improvement is often not evident for several weeks or months. Treatment may reduce the risk of disease progression even in the absence of symptomatic improvement. Therefore, enalapril dosage is usually titrated to a predefined target dose (e.g. at least 20 mg/day) or to the maximum tolerated dose, rather than adjusted solely according to symptoms, and maintained long term.
For the treatment of symptomatic congestive heart failure, enalapril is usually administered in combination with a cardiac glycoside, a diuretic, and a beta-blocker. Therapy should be initiated at a low dose and gradually increased.
In adult patients with heart failure and normal renal function and serum sodium levels, the usual initial dose is 2.5 mg once or twice daily, with monitoring for hypotension. The usual maintenance dose is 5–20 mg/day, administered in two pided doses. The maximum recommended dose is 40 mg/day in two pided doses.
Dose adjustment in renal impairment:
For patients with creatinine clearance (Clcr) between 30 and 80 ml/min, the recommended dose is 5 mg/day, which may be titrated up to a maximum of 40 mg/day.
For patients with creatinine clearance below 30 ml/min, the recommended initial dose is 2.5 mg/day, with dose adjustment until blood pressure is adequately controlled.
In patients with heart failure associated with serum sodium levels below 130 mEq/L or serum creatinine greater than 1.6 mg/dL, treatment should be initiated at 2.5 mg/day and increased, if necessary, to twice daily dosing, up to a maximum dose of 40 mg/day.
Dose adjustment in hepatic impairment: The hydrolysis of enalapril to enalaprilat may be delayed; however, the pharmacological effect is not altered, no dose adjustment is required.
CONTRAINDICATIONS
• Hypersensitivity to any component of the product
• Angioedema occurring during previous treatment with ACE inhibitors.
• Bilateral renal artery stenosis or renal artery stenosis in patients with a solitary kidney.
• Aortic valve stenosis and severe obstructive cardiomyopathy.
• Pre-existing hypotension.
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.
