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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.

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Hypertension

Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.


See all Amlobenz indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Amlobenz (Amlodipine / Benazepril)

30-Minute BP Monitoring Reduces White-Coat Hypertension (CME/CE)
Source: MedPage Today Nephrology [2017.03.14]
(MedPage Today) -- But experts question feasibility, need in primary care setting

Study reveals link between hypertension and brain changes in rats
Source: Hypertension News From Medical News Today [2017.03.10]
New research investigates the changes in brain activity and arterial blood flow that occur with the onset of hypertension in rats.

Evidence review supports pediatric use of PDE-5 inhibitors for pulmonary hypertension
Source: Hypertension News From Medical News Today [2017.02.28]
A systematic review of the comparative effectiveness and safety of phosphodiesterase type 5 (PDE-5) inhibitors in pediatric patients with pulmonary hypertension published in Pediatrics demonstrates...

Late-onset hypertension may lower dementia risk, study finds
Source: Hypertension News From Medical News Today [2017.01.17]
For the first time, a study investigates the link between high blood pressure later in life and the risk of dementia and cognitive decline.

New guidelines raise upper hypertension limit for 'otherwise healthy' over-60s
Source: Hypertension News From Medical News Today [2017.01.17]
New guidelines say treat otherwise healthy patients aged 60 and older when persistent systolic blood pressure is at or above 150 mm Hg, not 140 mm Hg.

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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)

Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fed Conditions [Completed]

Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions [Completed]

Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions [Completed]
The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under fasting conditions.

Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions [Completed]
The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under non-fasting (fed) conditions.

Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions [Completed]
The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance under fed conditions.

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Page last updated: 2017-03-14

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