Enalapril Maleate

ENALAPRIL

Manufacturer: Amneal Pharmaceuticals NY LLC

Score: 144.0

Quick Summary

Enalapril maleate is an angiotensin-converting enzyme (ACE) inhibitor used to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction. It works by suppressing the renin-angiotensin-aldosterone system, which leads to decreased blood pressure and improved cardiac output. The recommended initial dose for adults with hypertension is 5 mg once daily, while for heart failure, it is 2.5 mg twice daily. Important safety information includes the risk of fetal harm, angioedema, and hyperkalemia. Contraindications include a history of angioedema, hereditary or idiopathic angioedema, and co-administration with aliskiren in patients with diabetes. Special population considerations include use during pregnancy, pediatric use, and geriatric use, with careful monitoring and dose adjustments as needed.

Key Clinical Findings and Indications

Treatment of hypertension in adults and children older than one month
Treatment of symptomatic heart failure
Treatment of asymptomatic left ventricular dysfunction

Important Safety Information

Warning

When pregnancy is detected, discontinue enalapril maleate oral solution as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Contraindications

A history of angioedema or hypersensitivity related to previous treatment with an ACE inhibitor
Hereditary or idiopathic angioedema
Co-administration with aliskiren in patients with diabetes

Adverse Reactions

Angioedema
Hypotension
Hepatic failure
Renal impairment
Hyperkalemia

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with renal impairment or those taking diuretics.

Hypertension

Adult Dose

5 mg once daily

Pediatric Dose

0.08 mg/kg (up to 5 mg) once daily

Heart Failure

Adult Dose

2.5 mg twice daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Discontinue enalapril maleate oral solution as soon as possible when pregnancy is detected

Nursing Mothers

It is not known whether enalapril is excreted in human milk

Pediatric Use

Enalapril maleate oral solution is not recommended in neonates (i.e., infants 1 month of age or less)

Geriatric Use

Care should be taken in dose selection, and it may be useful to monitor renal function

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