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Univasc (Moexipril Hydrochloride) - Summary




See full prescribing information for complete boxed warning.

  • When pregnancy is detected, discontinue univasc ® as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity


univasc® (moexipril hydrochloride), the hydrochloride salt of moexipril, has the empirical formula C27H34N2O7 ·HCl and a molecular weight of 535. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat.

univasc® is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics.

In using univasc®, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that univasc® does not have a similar risk (see WARNINGS).

In considering use of univasc®, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema).
See all Univasc indications & dosage >>


Published Studies Related to Univasc (Moexipril)

Moexipril shows a long duration of action related to an extended pharmacokinetic half-life and prolonged ACE inhibition. [2002.01]
OBJECTIVE: To characterize the lipophilic ACE inhibitor moexipril and its active metabolite moexiprilat regarding the duration of action, the susceptibility of the pharmacokinetics and pharmacodynamics to food intake and the concentration-dependent effect... CONCLUSION: Moexiprilat showed an extended duration of action owing to a long terminal pharmacokinetic half-life and produced a persistent ACE inhibition. Although the pharmacokinetics were partly influenced by food intake, ACE inhibition was not affected. This might be explained by a second compartment directly related to the ACE which is less prone to food effects and the reaching of a ceiling in the sigmoidal concentration-effect curve even with the lower Cmax concentrations associated with the postprandial state.

Efficacy and tolerability of moexipril and nitrendipine in postmenopausal women with hypertension. MADAM study group. Moexipril as Antihypertensive Drug After Menopause. [1999.05]
OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of the new angiotensin-converting enzyme (ACE) inhibitor moexipril and the calcium antagonist nitrendipine in postmenopausal women with mild to moderate hypertension... CONCLUSION: The results of the study suggest that moexipril and nitrendipine are equieffective in the given dosages. In the patient population of postmenopausal women, the ACE inhibitor moexipril appears to have an advantage over the calcium antagonist nitrendipine with regard to tolerability.

Co-administration of an ACE-inhibitor (moexipril) and hormonal replacement therapy in postmenopausal women. [1999.05]
Co-administration of antihypertensive drug therapy and hormonal replacement therapy (HRT) is frequent in postmenopausal women but it is not known whether HRT interacts with concomitant antihypertensive therapy. The present study was designed to investigate efficacy and safety of the ACE inhibitor moexipril in comparison to placebo in hypertensive, postmenopausal women on HRT...

Comparison between moexipril and atenolol in obese postmenopausal women with hypertension. [1998.09.20]
The present study investigated the effect of the new ACE-inhibitor moexipril versus the beta 1-adrenergic blocker atenolol on metabolic parameters, adverse events (AEs) and sitting systolic (SSBP) and sitting diastolic blood pressure (SDBP) in obese postmenopausal women with hypertension (stage I and II)...

Increased arterial distensibility in postmenopausal hypertensive women with and without hormone replacement therapy after acute administration of the ACE inhibitor moexipril. [1998.09]
Menopause and essential hypertension are associated with a decreased compliance and distensibility of the arteries. ACE inhibitors have been shown to improve arterial distensibility.The changes in PWV and pulse pressure are of similar magnitude in women with and without HRT.

more studies >>

Clinical Trials Related to Univasc (Moexipril)

A Relative Bioavailability Study of Moexipril HCl 15 mg Tablets Under Fasting Conditions [Completed]
The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg tablets (by Paddock Laboratories, Inc.) with that of Univasc 15mg tablets (by Schwarz Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under fasting conditions.

Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions [Completed]
The objective of this study is to compare the relative bioavailability of Moexipril HCl/hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC 15/25 mg tablets (Schwartz Pharma) in healthy, adult non-smoking subjects under fasting conditions.

Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-Fasting Conditions [Completed]
The objective of this study is to compare the relative bioavailability of moexipril HCl/ hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC 15/25 mg tablets (Schwartz Pharma) in healthy, adult, non-smoking subjects under non-fasting conditions.

Moexipril for Primary Biliary Cirrhosis [Completed]
The blockade of angiotensin II synthesis attenuates hepatic fibrosis in different experimental models of chronic liver injury. We aimed to determine the safety and efficacy of moexipril, an angiotensin-converting enzyme (ACE) inhibitor, on liver biochemistries, Mayo risk score, and health-related quality of life in patients with primary biliary cirrhosis (PBC) who have had a suboptimal response to ursodeoxycholic acid (UDCA).

A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions [Completed]
The purpose of this study was to evaluate the relative bioavailability of Paddock Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets with a reference formulation Uniretic(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets, under fasting conditions.

more trials >>

Page last updated: 2006-01-31

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