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Lotensin (Benazepril Hydrochloride) - Summary

 
 



USE IN PREGNANCY

When used in pregnancy, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, Lotensin should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

 

LOTENSIN SUMMARY

USE IN PREGNANCY

Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol.

Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.

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

Black patients receiving ACE-inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.


See all Lotensin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Lotensin (Benazepril)

Efficacy and duration of benazepril plus amlodipine or hydrochlorothiazide on 24-hour ambulatory systolic blood pressure control. [2011.02]
The combination of benazepril plus amlodipine was shown to be more effective than benazepril plus hydrochlorothiazide in reducing cardiovascular events in the Avoiding Cardiovascular Events through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial... The 24-hour blood pressure control was similar in both treatment arms, supporting the interpretation that the difference in cardiovascular outcomes favoring a renin angiotensin system blocker combined with amlodipine rather than hydrochlorothiazide shown in the ACCOMPLISH trial was not caused by differences in blood pressure, but instead intrinsic properties (metabolic or hemodynamic) of the combination therapies.

[Comparison of benazepril monotherapy to amlodipine plus benazepril in the treatment of patients with mild and moderate hypertension: a multicentre, randomized, double-blind, parallel-controlled study]. [2011.01]
OBJECTIVE: To evaluate the efficacy and tolerability of the fixed combination of amlodipine 5 mg/benazepril 10 mg once-daily therapy, compared with benazepril, 10 mg, monotherapy in patients with mild and moderate hypertension, and to evaluate the 24 h antihypertensive efficacy and the duration of action by ambulatory blood pressure monitoring... CONCLUSIONS: The combination therapy with benazepril/amlodipine was superior to benazepril monotherapy and was well tolerated in patients with essential hypertension and allowing a satisfactory BP control for 24 hours.

Comparative efficacy and safety of amlodipine/benazepril combination therapy and amlodipine monotherapy in severe hypertension. [2010.06]
This multicentre, double-blind, trial in subjects with severe hypertension compared the efficacy and tolerability of two parallel drug regimens: A/B (amlodipine/benazepril: 5/20 or 10/40 mg daily, if necessary) with A (amlodipine: 5 or 10 mg daily, if necessary)... We conclude that titration of amlodipine and benazepril in single-pill combinations is more effective than titration of amlodipine alone for rapid BP control in patients with severe hypertension.

A randomized controlled clinical trial of the use of benazepril and heparin for the treatment of chronic kidney disease in dogs. [2009.04.15]
OBJECTIVE: To investigate the effects of benazepril and heparin on renal function and blood pressure in dogs with chronic kidney disease... CONCLUSIONS AND CLINICAL RELEVANCE: Results suggested that administration of benazepril had beneficial effects in dogs with chronic kidney disease but that short-term administration of heparin in conjunction with benazepril did not appear to provide any additional benefit.

Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. [2008.12.04]
BACKGROUND: The optimal combination drug therapy for hypertension is not established, although current U.S. guidelines recommend inclusion of a diuretic. We hypothesized that treatment with the combination of an angiotensin-converting-enzyme (ACE) inhibitor and a dihydropyridine calcium-channel blocker would be more effective in reducing the rate of cardiovascular events than treatment with an ACE inhibitor plus a thiazide diuretic... CONCLUSIONS: The benazepril-amlodipine combination was superior to the benazepril-hydrochlorothiazide combination in reducing cardiovascular events in patients with hypertension who were at high risk for such events. (ClinicalTrials.gov number, NCT00170950.) 2008 Massachusetts Medical Society

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Clinical Trials Related to Lotensin (Benazepril)

Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fed conditions.

Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting conditions.

Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan amlodipine and benazepril HCl 10 mg/20 mg to Novartis Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10 mg/20 mg) dose administered under fed conditions.

Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10mg/20mg) dose administered under fasting conditions.

Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension [Completed]
This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure is not adequately controlled with benazepril monotherapy during a 4 week run-in period will be randomly allocated to double blind treatment over 8 weeks with either a combination of benazepril/hydrochlorothiazide per day or continuation of benazepril per day.

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Reports of Suspected Lotensin (Benazepril) Side Effects

Completed Suicide (13)Toxicity TO Various Agents (7)Fall (6)Pleural Effusion (6)Hypovolaemia (6)RIB Fracture (6)Pancreatic Cyst (6)Pancreatitis (6)Medication Error (3)Back Disorder (3)more >>


Page last updated: 2011-12-09

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