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Amlobenz (Amlodipine Besylate / Benazepril Hydrochloride) - Summary

 
 



BOXED WARNING

WARNING: AVOID USE IN PREGNANCY  

When pregnancy is detected, discontinue amlodipine besylate and benazepril hydrochloride as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.4)

 

AMLOBENZ SUMMARY

Amlodipine besylate and benazepril hydrochloride capsules is a combination of amlodipine besylate and benazepril hydrochloride.  Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine besylate and benazepril hydrochloride capsules are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg.

Amlodipine besylate and benazepril hydrochloride capsules is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension (1) in patients not adequately controlled on monotherapy with either agent


See all Amlobenz indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Amlobenz (Amlodipine / Benazepril)

High fitness levels reduce hypertension risk
Source: Cardiovascular / Cardiology News From Medical News Today [2014.12.18]
Researchers have found that individuals with high levels of physical fitness are less likely to develop high blood pressure in a new study.

Poor semen quality linked to hypertension, other health problems
Source: Dermatology News From Medical News Today [2014.12.10]
A study of more than 9,000 men with fertility problems has revealed a correlation between the number of different defects in a man's semen and the likelihood that the man has other health problems.

How obesity causes hypertension
Source: Endocrinology News From Medical News Today [2014.12.09]
The link between obesity and cardiovascular diseases is well acknowledged. Being obese or overweight is a major risk factor for the development of elevated blood pressure, and cardiovascular diseases.

Picture of Hypertension
Source: MedicineNet Pregnancy Induced Hypertension Specialty [2014.12.09]
Title: Picture of Hypertension
Category: Images
Created: 2/3/2011 1:47:00 PM
Last Editorial Review: 12/9/2014 12:00:00 AM

Pregnant women who have donated a kidney are at increased risk for hypertension, preeclampsia
Source: Transplants / Organ Donations News From Medical News Today [2014.11.23]
Nearly 30,000 people become living kidney donors worldwide each year, and many are young women.

more news >>

Published Studies Related to Amlobenz (Amlodipine / Benazepril)

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.

An eight-week, multicenter, randomized, double-blind study to evaluate the efficacy and tolerability of fixed-dose amlodipine/benazepril combination in comparison with amlodipine as first-line therapy in chinese patients with mild to moderate hypertension. [2008.06]
CONCLUSIONS: In this group of patients, comparable antihypertensive effects were seen with the fixed-dose combination therapy, compared with amlodipine monotherapy. Both treatments appeared well tolerated in the studied population, but cough was more common in the fixed-dose combination group.

The effects of high-dose amlodipine/benazepril combination therapies on blood pressure reduction in patients not adequately controlled with amlodipine monotherapy. [2007.03]
BACKGROUND: This study compared the efficacy and safety of amlodipine/benazepril (10/40 mg/day and 10/20 mg/day) with amlodipine 10 mg/day in patients whose blood pressure (BP) was not adequately controlled with amlodipine monotherapy... CONCLUSION: Amlodipine/benazepril combinations were well tolerated and resulted in significant BP reductions and better BP responder rates than amlodipine monotherapy.

Comparative efficacy and safety of amlodipine/benazepril combination therapy and amlodipine monotherapy in severe hypertension. [2010]
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.

Compliance with antihypertensive therapy in the elderly: a comparison of fixed-dose combination amlodipine/benazepril versus component-based free-combination therapy. [2008]
BACKGROUND: Treatment regimens that require fewer dosage units and less frequent dosing to decrease the complexity and cost of care are among the strategies recommended to improve compliance with antihypertensive therapy. Simplifying therapy may be particularly important for elderly patients, who are more likely to have co-morbid conditions and to be taking multiple medications. OBJECTIVE: To determine rates of compliance with antihypertensive therapy and total costs of care among elderly Medicaid recipients treated with fixed-dose combination amlodipine besylate/benazepril versus a dihydropyridine calcium channel antagonist and ACE inhibitor prescribed as separate agents (free combination)... CONCLUSION: Use of fixed-dose amlodipine besylate/benazepril HCl by elderly Medicaid recipients was associated with improved compliance and lower healthcare costs compared with a dihydropyridine calcium channel antagonist and ACE inhibitor prescribed as separate agents.

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Clinical Trials Related to Amlobenz (Amlodipine / Benazepril)

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.

TarkaŽ vs. LotrelŽ in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM) [Active, not recruiting]
The primary objective of this study is to determine if trandolapril/verapamil (TarkaŽ) is superior to amlodipine/benazepril (LotrelŽ) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy

Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors [Recruiting]
RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help lower blood pressure.

PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril, ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.

Preventing Microalbuminuria in Type 2 Diabetes [Recruiting]
In people with type 2 diabetes, microalbuminuria is a strong, independent risk factor for diabetic nephropathy and cardiovascular morbidity and mortality. ACE inhibitor therapy decreased the risk of microalbuminuria in hypertensive subjects with type 2 diabetes and normoalbuminuria by about 40%. Available data suggest that angiotensin II receptor blockers (ARBs) might have a similar renoprotective effect and that this effect might be increased by combined ACE inhibitor therapy.

The study will evaluate the effects, at similar blood pressure control (systolic/diastolic <130/80 mmHg), for a period of three years, of dual renin-angiotensin-system (RAS) blockade by benazepril and valsartan combination therapy as compared to single RAS blockade by benazepril or valsartan alone on microalbuminuria and cardiovascular events in high-risk patients with type 2 diabetes, creatinine <1. 5 mg/dl, no evidence of microalbuminuria but at high risk of renal disease, with hypertension and a urinary albumin excretion between 7 and 19 microgram/min. The relationship between albuminuria and cardiovascular outcomes will also be evaluated.

The study is expected to show a more effective prevention of microalbuminuria and cardiovascular events with combined than with single drug ACE inhibitor or ARB therapy. As compared to ACE inhibitor, ARB therapy is expected to have a similar effect on microalbuminuria, but an inferior cardioprotective effect. Applied to clinical practice, the findings should help preventing renal and cardiovascular complications, and related treatment costs, of type 2 diabetes.

A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril [Active, not recruiting]

more trials >>


Page last updated: 2014-12-18

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