Ramipril precautions

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Pregnancy

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, discontinue therapy as soon as possible.

Category D (second, third trimester); Category C (first trimester).

Discontinue use in pregnant patients; fetal / neonatal injury and death have occurred. Closely observe infants with histories of in utero exposure.

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

May show higher blood levels of active metabolite.

Renal Function

Dosage reduction is required in patients with renal function impairment. May further decrease renal function with elevations in BUN and serum creatinine caused by decreased renal perfusion.

Hepatic Function

Use drug with caution. Dosage reduction may be required because of impaired metabolism.

Angioedema

Angioedema may occur. Use drug with extreme caution in patients with hereditary angioedema.

Cough

Chronic cough may occur during treatment; it is more common in women.

Hepatic failure

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death.

Hypotension / first-dose effect

Significant decreases in BP may occur following first dose, especially in severely salt- or volume-depleted patients (such as those receiving diuretics) or those with heart failure.

Neutropenia and agranulocytosis

Neutropenia and agranulocytosis have occurred with similar agents; risk appears greater in presence of renal dysfunction, heart failure, or immunosuppression.

Proteinuria

Proteinuria has occurred with agents in this class, especially with high doses or prior renal disease.

Adapted from the FDA Package Insert.