UNIVASC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for UNIVASC (UNIVASC).
Angiotensin-converting enzyme (ACE) inhibitor; inhibits conversion of angiotensin I to angiotensin II, reducing vasoconstriction and aldosterone secretion, leading to decreased blood pressure.
| Metabolism | Hepatic (hydrolysis to moexiprilat); moexiprilat is further glucuronidated. |
| Excretion | Univasc (moexipril) is primarily eliminated via renal excretion (approximately 50% of absorbed dose as unchanged drug and metabolites) and fecal excretion (about 50%). |
| Half-life | The terminal elimination half-life of moexiprilat, the active metabolite, is approximately 9.8 hours in patients with normal renal function. This supports once-daily dosing, though the antihypertensive effect may persist beyond 24 hours with continued therapy. |
| Protein binding | Moexiprilat is approximately 90% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | The apparent volume of distribution (Vd) is about 0.26 L/kg, indicating limited extravascular distribution and predominantly remaining in the vascular space. |
| Bioavailability | Oral bioavailability of moexipril is approximately 13% due to extensive first-pass metabolism to the active metabolite moexiprilat. Food does not significantly alter absorption, but administration with a high-fat meal may slightly reduce absorption. |
| Onset of Action | Oral administration: onset of antihypertensive effect occurs within 1-2 hours, with peak blood pressure reduction at 4-6 hours. |
| Duration of Action | Duration of antihypertensive effect is approximately 24 hours with once-daily dosing, allowing for sustained blood pressure control. Clinical trials show trough-to-peak ratios consistent with once-daily administration. |
Initial: 7.5 mg orally once daily; titrate to 15-30 mg once daily. Maximum: 60 mg/day.
| Dosage form | TABLET |
| Renal impairment | CrCl 20-40 mL/min: initial dose 3.75 mg once daily; maximum 15 mg/day. CrCl <20 mL/min: not recommended. |
| Liver impairment | Child-Pugh Class A and B: no adjustment required. Child-Pugh Class C: not studied; use with caution. |
| Pediatric use | Not recommended for pediatric patients. |
| Geriatric use | Initial dose 3.75 mg once daily; titrate cautiously. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for UNIVASC (UNIVASC).
| Breastfeeding | No data on moexipril excretion in human milk. ACE inhibitors are generally considered compatible with breastfeeding based on low milk transfer for some agents (e.g., captopril, enalapril). M/P ratio unknown. Caution is advised, especially in preterm or renally impaired infants. |
| Teratogenic Risk | UNIVASC (moexipril) is an ACE inhibitor. Exposure during the first trimester may be associated with a low absolute risk of congenital malformations, particularly cardiovascular and central nervous system defects. Exposure during the second and third trimesters is associated with a high risk of fetal renal dysfunction, oligohydramnios, skull ossification defects, and neonatal hypotension, acute renal failure, and death. Use is contraindicated in pregnancy. |
■ FDA Black Box Warning
Fetal Toxicity: Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible when pregnancy is detected.
| Serious Effects |
["Hypersensitivity to moexipril or any ACE inhibitor","History of angioedema related to previous ACE inhibitor therapy","Hereditary or idiopathic angioedema","Pregnancy (second and third trimesters)","Concomitant use with aliskiren in patients with diabetes"]
| Precautions | ["Angioedema (including intestinal angioedema)","Hypotension (especially in volume-depleted patients)","Neutropenia/agranulocytosis (higher risk with renal impairment or collagen vascular disease)","Hepatic failure (rare)","Renal impairment (monitor renal function)","Hyperkalemia (risk factors include renal impairment, diabetes, potassium supplements)"] |
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| Fetal Monitoring | Monitor maternal blood pressure, renal function (serum creatinine, BUN, urinalysis), electrolytes (especially potassium). Fetal monitoring: serial ultrasound for amniotic fluid volume and fetal growth if exposure after first trimester. Neonatal monitoring for hypotension and renal function if exposure near term. |
| Fertility Effects | No specific data on moexipril effects on human fertility. ACE inhibitors are not known to impair fertility. In animal studies, no adverse effects on fertility were observed. |