ENALAPRIL MALEATE

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ENALAPRIL MALEATE
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Infant Data

Results

MEDICAL INFORMATION

INDICATIONS

Treatment of moderate to severe hypertension. Afterload reduction in patients with congestive heart failure.

CONTRAINDICATIONS/PRECAUTIONS

Use with extreme caution in patients with impaired renal function: oliguria and increased serum creatinine occur frequently.

ADVERSE EFFECTS

The most common adverse event in infants (cohort study; n=662) younger than 120 days, including term and preterm infants without significant congenital anomalies, on enalapril were hyperkalemia (13%), elevated serum creatinine (5%), hypotension (4%), and death (0.5%). Risk factors for adverse events were postnatal age younger than 30 days at first exposure and longer duration of therapy. The CrCl significantly decreased in preterm and term neonates with cardiovascular disease after initiation of ACEIs (captopril or enalapril) in a retrospective review (n=206). The body surface area was less than 0.33 m2 for all neonates.

MONITORING

Frequent assessment of blood pressure, particularly after the first dose. Periodic assessment of renal function and serum potassium.