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Exforge (Amlodipine Besylate / Valsartan) - Summary

 
 



USE IN PREGNANCY

When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.   When pregnancy is detected, Exforge ®  (amlodipine and valsartan) should be discontinued as soon as possible.

See WARNINGS: Fetal/Neonatal Morbidity and Mortality

 

EXFORGE SUMMARY

Exforge

Exforge® (amlodipine and valsartan) is a fixed combination of amlodipine and valsartan. Exforge® contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol.

Exforge® (amlodipine and valsartan) is indicated for the treatment of hypertension.   

This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).


See all Exforge indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Exforge (Amlodipine / Valsartan)

Pulmonary Hypertension
Source: MedicineNet Fainting Specialty [2015.02.19]
Title: Pulmonary Hypertension
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 2/19/2015 12:00:00 AM

"Danger" molecule may be new therapeutic target for male hypertension
Source: Hypertension News From Medical News Today [2015.02.17]
Higher levels of a "danger" molecule may be one reason males tend to become hypertensive earlier and more severely than females, scientists say.

New Hypertension Recs Planned in 2016
Source: MedPage Today Cardiovascular [2015.02.17]
(MedPage Today) -- AHA/ACC recommendations will replace JNC schema.

Pregnancy associated hypertension linked to an increased frequency of subsequent hypertension and metabolic syndrome
Source: Hypertension News From Medical News Today [2015.02.04]
In a study to be presented on Feb. 5 in an oral concurrent session at 2:45 p.m.

New hypertension guidelines could save lives and money
Source: Hypertension News From Medical News Today [2015.01.30]
Increased treatment of severe hypertension particularly cost-effectiveFull implementation of new hypertension guidelines could prevent 56,000 cardiovascular disease events (mostly heart attacks...

more news >>

Published Studies Related to Exforge (Amlodipine / Valsartan)

Initial combination therapy with amlodipine/valsartan compared with monotherapy in the treatment of hypertension. [2011.09]
Achieving target blood pressure (BP) is influenced by baseline BP. Post hoc analyses of a placebo-controlled trial of amlodipine/valsartan versus monotherapies were conducted to characterize BP control by baseline BP...

Moderate versus intensive treatment of hypertension using amlodipine/valsartan and with the addition of hydrochlorothiazide for patients uncontrolled on angiotensin receptor blocker monotherapy: results in racial/ethnic subgroups. [2011.07]
Combination therapy may reduce racial/ethnic differences in response to antihypertensives. In this post-hoc analysis, we evaluated treatment response by race/ethnicity among hypertensive adults enrolled in a 12-week, double-blind study in which patients previously uncontrolled (mean sitting systolic blood pressure [MSSBP] >/=150 and <200 mm Hg) on angiotensin receptor blocker (ARB) monotherapy (other than valsartan) for 28 days or more (n = 728) were randomized to amlodipine/valsartan 10/320 mg (intensive) or 5/160 mg (moderate)...

Evaluation of pharmacokinetic interactions between amlodipine, valsartan, and hydrochlorothiazide in patients with hypertension. [2011.06]
The steady-state pharmacokinetic (PK) interaction potential between amlodipine (10 mg), valsartan (320 mg), and hydrochlorothiazide (HCTZ; 25 mg) was evaluated in patients with hypertension in a multicenter, multiple-dose, open-label, 4-cohort, parallel-group study... All treatments were safe and well tolerated.

The role of ambulatory blood pressure monitoring compared with clinic and home blood pressure measures in evaluating moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. [2011.04]
OBJECTIVES: Ambulatory blood pressure monitoring (ABPM) has greater predictive value than office blood pressure (BP) with respect to hypertension-related target-organ damage and morbidity. ABPM in a subset of 80 patients from the Exforge Target Achievement trial (N=728) was used to compare the efficacy of intensive-treatment and moderate-treatment regimens of amlodipine/valsartan, and to determine whether treatment differences could be better assessed with ABPM than with office or home BP. Home BP was measured on the morning of clinic visits to minimize differences that timing might have on home versus office BP measures... CONCLUSION: In this first randomized trial evaluating the effects of intensive versus moderate dosing of the combination of amlodipine/valsartan, our data suggest that ABPM was a better method for assessing between-treatment differences than clinic or home BP recordings, although measurement of home BP as a single recording was a limitation of our trial.

Efficacy of morning and evening dosing of amlodipine/valsartan combination in hypertensive patients uncontrolled by 5 mg of amlodipine. [2011.04]
OBJECTIVES: This study compared the effects of morning and evening dosing of amlodipine/valsartan combination on 24-h blood pressure (BP) in patients uncontrolled by amlodipine (5 mg)... CONCLUSION: These results indicate that, in patients with BP uncontrolled by amlodipine (5 mg), morning and evening treatment with amlodipine/valsartan combination have similar effects on circadian BP, especially when 24-h mean values are considered.

more studies >>

Clinical Trials Related to Exforge (Amlodipine / Valsartan)

Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)
The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.

Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension [Completed]
The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2. 5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies and placebo.

Effectiveness of EXforge® and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients [Recruiting]
This study is to demonstrate that valsartan/amlodipine 80/5 mg has superior efficacy compared with nifedipine 30mg alone in reducing the mean sitting diastolic blood pressure (MSDBP) and mean sitting systolic blood pressure (MSSBP) from baseline in patients with mild to moderate hypertension not adequately controlled with monotherapy.

A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects [Not yet recruiting]

Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension. [Completed]
This trial will compare valsartan and amlodipine combination therapies to both valsartan and amlodipine, and placebo for the treatment of hypertension.

more trials >>

Reports of Suspected Exforge (Amlodipine / Valsartan) Side Effects

Blood Pressure Increased (85)Death (64)Oedema Peripheral (57)Cerebrovascular Accident (57)Fall (46)Hypertension (45)Diabetes Mellitus (44)Malaise (40)Pneumonia (35)Dyspnoea (33)more >>


Page last updated: 2015-02-19

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