Risk Factor: CM*
Class: Cardiovascular drugs/ Antihypertensives/ Angiotensin-converting enzyme inhibitors
Fetal Risk Summary
The prodrug, moexipril, is rapidly metabolized to the active drug, moexiprilat. It is indicated in the management of hypertension either alone, or in combination with thiazide diuretics. The active metabolite, moexiprilat, is a competitive inhibitor of angiotensin Iconverting enzyme (ACE inhibitor), thus preventing the conversion of angiotensin I to angiotensin II.
Reproduction studies have been conducted in pregnant rats and rabbits (1). Doses up to 90.9 and 0.7 times, respectively, the maximum recommended human dose on a body surface area basis revealed no embyrotoxic, fetotoxic, or teratogenic effects.
It is not known if moexipril or moexiprilat cross the human placenta. The molecular weight (about 535 for the hydrochloride salt forms) is low enough, however, that transfer to the fetus should be expected.
No reports describing the use of moexipril during human pregnancy have been located. Based on the human pregnancy experience with other ACE inhibitors, moexipril exposure during the 1st trimester would not be expected to represent a risk to the fetus. However, use of moexipril during the 2nd and 3rd trimesters may cause teratogenicity and severe fetal and neonatal toxicity (see Captopril or Enalapril). Fetal toxic effects may include anuria, oligohydramnios, fetal hypocalvaria, intrauterine growth retardation, prematurity, and patent ductus arteriosus. Anuria-associated oligohydramnios may produce fetal limb contractures, craniofacial deformation, and pulmonary hypoplasia. Severe anuria and hypotension that is resistant to both pressor agents and volume expansion may occur in the newborn following in utero exposure to ACE inhibitors.
In cases in which the mother’s disease requires moexipril (or another ACE inhibitor), the lowest possible dose should be used. Close monitoring of amniotic fluid levels and fetal well-being should be conducted during gestation followed by close observation of renal function and blood pressure in the newborn.
[*Risk Factor D if used in the 2nd and/or 3rd trimesters according to the manufacturer.]
Breast Feeding Summary
No reports describing the use of moexipril in human lactation have been located. The molecular weight (about 535 for the salt forms of the parent drug and metabolite) suggests that excretion into breast milk should be expected. The effect of this exposure on a nursing infant are unknown. However, other ACE inhibitors are excreted into breast milk and are considered compatible with breast feeding by the American Academy of Pediatrics (see Captopril and Enalapril).
- Product information. Univasc. Schwarz Pharma, 2001.