Enalapril Maleate

ENALAPRIL MALEATE

Manufacturer: Northwind Pharmaceuticals

Score: 143.0

Quick Summary

Enalapril maleate oral solution is an angiotensin-converting enzyme (ACE) inhibitor used to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction. It works by relaxing blood vessels, making it easier for the heart to pump blood. The drug has several key clinical findings and indications, including its effectiveness in reducing blood pressure and improving survival in patients with heart failure. However, it also has important safety information and contraindications, such as the risk of fetal harm during pregnancy and the potential for adverse reactions like angioedema and hypotension. The main dosing recommendations vary depending on the condition being treated, with initial doses ranging from 2.5 to 5 mg daily for adults and 0.08 mg/kg daily for pediatric patients. Special population considerations include the risk of fetal harm during pregnancy, the potential for adverse reactions in pediatric and geriatric patients, and the need for dose adjustments in patients with renal impairment.

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.

Contraindications

History of angioedema or hypersensitivity related to previous treatment with an ACE inhibitor
Hereditary or idiopathic angioedema
Do not co-administer aliskiren with enalapril maleate oral solution in patients with diabetes
In combination with a neprilysin inhibitor

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, titrate up to 40 mg daily

Pediatric Dose

0.08 mg/kg once daily, up to 5 mg daily

Heart Failure

Adult Dose

2.5 mg twice daily, titrate up to 20 mg twice daily

Pediatric Dose

Not established

Asymptomatic Left Ventricular Dysfunction

Adult Dose

2.5 mg twice daily, titrate up to 10 mg twice daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Enalapril maleate oral solution can cause fetal harm when administered to a pregnant woman
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death

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)
Enalapril maleate oral solution is not recommended in preterm infants who have not reached a corrected post-conceptual age of 44 weeks

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function

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