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These highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets for oral administration Initial U.S. Approv | AMLODIPINE BESYLATE [WOCKHARDT LIMITED] | BioPortfolio

12:01 EST 27th January 2019 | BioPortfolio

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Other adverse experiences that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table:

Adverse  Event
2.5 mg 
N=275
5 mg 
N=296
10 mg 
N=268
Placebo 
N=520
Edema
1.8
3.0
10.8
0.6
Dizziness
1.1
3.4
3.4
1.5
Flushing
0.7
1.4
2.6
0.0
Palpitation
0.7
1.4
4.5
0.6
Placebo-Controlled Studies

Amlodipine Besylate (%)
(N=1730)
Placebo (%)
(N=1250)
Headache 
7.3
7.8
Fatigue 
4.5
2.8
Nausea 
2.9
1.9
Abdominal Pain 
1.6
0.3
Somnolence 
1.4
0.6

Amlodipine Besylate
Placebo
Adverse  Event
Male=% 
(N=1218)
Female=% 
(N=512)
Male=% 
(N=914)
Female=% 
(N=336)
  Edema 
5.6
14.6
1.4
5.1
  Flushing 
1.5
4.5
0.3
0.9
  Palpitations 
1.4
3.3
0.9
0.9
  Somnolence 
1.3
1.6
0.8
0.3
Table 1. Incidence of Significant Clinical Outcomes for CAMELOT
Clinical Outcomes
N (%)
Amlodipine Besylate
(N=663)
Placebo
(N=655)
Risk Reduction
(p-value)
Composite CV Endpoint 110
(16.6)
151
(23.1)
31%
(0.003)
Hospitalization for Angina* 51
(7.7)
84
(12.8)
42%
(0.002)
Coronary Revascularization* 78
(11.8)
103
(15.7)
27%
(0.033)

Manufacturer

WOCKHARDT LIMITED

Active Ingredients

Source

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Clinical Trials [259 Associated Clinical Trials listed on BioPortfolio]

Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the ...

Efficacy and Safety Study of S-Amlodipine Gentisate Compared to Amlodipine Besylate to Treat Mild-to-Moderate Hypertension

The goal of this study is to compare the antihypertensive effect and tolerability of S-amlodipine gentisate with those of amlodipine besylate in patients with mild to moderate hypertension...

Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions

The purpose of this study is to determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fed conditions.

Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition

This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate a...

A Study to Evaluate the Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil in Essential Hypertension Patient Who Are Not Adequately Controlled With Amlodipine Besylate Monotherapy

Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination therapy on patients of essential hypertension who are not properly controlled by amlodipine bes...

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Effect of Hydrophilic and Hydrophobic Polymers on Permeation of S-Amlodipine Besylate through Intercalated Polymeric Transdermal Matrix: 3(2) Designing, Optimization and Characterization.

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