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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


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NEWS HIGHLIGHTS

Media Articles Related to Amlobenz (Amlodipine / Benazepril)

Deaths from pulmonary hypertension have increased, say CDC
Source: Cardiovascular / Cardiology News From Medical News Today [2014.04.04]
A study from the CDC finds that deaths from pulmonary hypertension - high blood pressure in the arteries leading from the heart to the lungs - have increased over the past decade.

Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Source: MedicineNet Brain Aneurysm Specialty [2014.04.02]
Title: Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Category: Diseases and Conditions
Created: 11/8/1998 8:47:00 PM
Last Editorial Review: 4/2/2014 12:00:00 AM

Children with glomerular kidney disease more likely to have hypertension as adults
Source: Hypertension News From Medical News Today [2014.03.20]
Men who as children had glomerular disease, a disorder of the portion of the kidney that filters blood and one that usually resolves with time, were more likely than men without childhood...

First guidelines for patients with pulmonary hypertension in sickle cell disease
Source: Blood / Hematology News From Medical News Today [2014.03.19]
Boston Medical Center (BMC) and Boston University School of Medicine (BUSM) physicians have helped create the first set of clinical guidelines for treating patients with pulmonary hypertension in...

Guidelines on the management of pulmonary hypertension of sickle cell disease
Source: Hypertension News From Medical News Today [2014.03.18]
The American Thoracic Society has developed clinical practice guidelines to help clinicians identify and manage patients with sickle cell disease who are at increased risk for mortality from...

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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.

Renal Protective Effects of Renin Angiotensin System (RAS) Inhibitor in Peritoneal Dialysis Patients [Recruiting]

Safety of Dual Blockage of Rennin-angiotensin System in Patients With Advanced Renal Insufficiency [Recruiting]
The primary aim of the present study is to assess the safety of combined treatment of benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced renal insufficiency.

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.

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Page last updated: 2014-04-04

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