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Amlodipine

Macleods Pharmaceuticals Limited

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use amlodipine besylate tablets USP safely and effectively. See full prescribing information for amlodipine besylate tablets USP. Amlodipine Besylate Tablets USP for oral administration Initial U.S. Approval: 1987INDICATIONS AND USAGE1.11.2DOSAGE AND ADMINISTRATION2.12.12.2Important Limitation:DOSAGE FORMS AND STRENGTHS3CONTRAINDICATIONS4WARNINGS AND PRECAUTIONS Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely.(5.1) Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate, particularly in patients with severe obstructive coronary artery disease. (5.2) Titrate slowly in patients with severe hepatic impairment. (5.4) Side Effects6 To report SUSPECTED ADVERSE REACTIONS,  contact Macleods Pharma USA, Inc. at 1-888-943-3210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . DRUG INTERACTIONS7.7USE IN SPECIFIC POPULATIONS8.18.38.4


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

1 INDICATIONS & USAGE

1.1 Hypertension













1.2 Coronary Artery Disease (CAD)


Chronic Stable Angina
Amlodipine besylate tablet USP is indicated for the symptomatic treatment of chronic stable angina.  Amlodipine besylate may be used alone or in combination with other antianginal agents.

Vasospastic Angina (Prinzmetal's or Variant Angina)




Angiographically Documented CAD

2 DOSAGE & ADMINISTRATION

2.1 Adults








AnginaAdverse Reactions (6)

Coronary artery disease:Clinical Studies (14.4)

2.2 Children


[see Clinical Pharmacology (12.4), Clinical Studies (14.1)].

3 DOSAGE FORMS & STRENGTHS


4 CONTRAINDICATIONS


5 WARNINGS AND PRECAUTIONS

5.1 Hypotension


5.2 Increased Angina or Myocardial Infarction


5.3 Patients with Hepatic Failure


6 ADVERSE REACTIONS

6.1 Clinical Trials Experience







 
 Amlodipine		  
Placebo

 2.5mg
N=275
5 mg
N=296 
10 mg
N=268
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



 
Amlodipine besylate (%)
Placebo (%) 

 (N=1730)
 (N=1250)

Fatigue
 4.5
2.8 

Nausea
 2.9
 1.9

Abdominal Pain
 1.6
 0.3

Somnolence
 1.4
 0.6



 
Amlodipine besylate
Placebo 

 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



Cardiovascular:

Central and Peripheral Nervous System:

Gastrointestinal:

General:1

Musculoskeletal System:1

Psychiatric:1

Respiratory System:1

Skin and Appendages:11

Special Senses:

System:

Autonomic Nervous System:

Metabolic and Nutritional:

Hemopoietic:

1

6.2 Postmarketing Experience







7 DRUG INTERACTIONS

7.1 In Vitro Data


7.2 Cimetidine


7.3 Grapefruit Juice


7.4 Magnesium and Aluminum Hydroxide Antacid


7.5 Sildenafil


7.6 Atorvastatin


7.7 Simvastatin


7.8 Digoxin


7.9 Ethanol (Alcohol)


7.10 Warfarin


7.11 CYP3A4 Inhibitors


7.12 CYP3A4 Inducers


7.13 Cyclosporine


7.14 Drug/Laboratory Test Interactions


8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy







222

2

8.3 Nursing Mothers


8.4 Pediatric Use


8.5 Geriatric Use


Dosage and Administration (2.1)

10 OVERDOSAGE




2


11 DESCRIPTION





202525663




Amlodipine

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action







12.2 Pharmacodynamics







12.3 Pharmacokinetics and Metabolism






12.4 Pediatric Patients


13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility


2323

32

3

14 CLINICAL STUDIES

14.1 Effects in Hypertension


Adult Patients


Pediatric Patients

14.2 Effects in Chronic Stable Angina



14.3 Effects in Vasospastic Angina



14.4 Effects in Documented Coronary Artery Disease







Figure 1 - Kaplan-Meier Analysis of Composite Clinical Outcomes for amlodipine versus Placebo

Amlodipine




Figure 2 – Effects on Primary Endpoint of amlodipine versus Placebo across Sub-Groups





Amlodipine




Clinical Outcomes
N (%)
 A mlodipine besylate
(N=663)
Placebo
(N=655)
Risk Reduction
(p-value)
Composite CV Endpoint
110
(16.6) 
 151
(23.1) 
 31%
(0.003)
Hospitalization for AnginaTotal patients with these events
51
(7.7)
 84
(12.8)
 42%
(0.002) 
Coronary RevascularizationTotal patients with these events
78
(11.8)
 103
(15.7)
 27%
(0.033)



14.5 Studies in Patients with Heart Failure





16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 5 mg Tablets






16.2 10 mg Tablets






16.3 Storage





 

17 PATIENT COUNSELING INFORMATION

Amlodipine besylate tablets USP


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What is amlodipine besylate?

Amlodipine besylate USP
High Blood Pressure (hypertension)
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What are the possible side effects of amlodipine besylate tablet?

Amlodipine besylate tablets









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How do I store amlodipine besylate tablets?

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General advice about amlodipine besylate tablets

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amlodipine besylate tabletsMacleods Pharma USA, Inc. at 1-888-943-3210.

Manufactured for:



Manufacturedby:





Revised : February 2013

PACKAGE LABEL PRINCIPAL DISPLAY PANEL









Amlodipine






Amlodipine

Amlodipine

Amlodipine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:33342-015
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
amlodipine besylate AMLODIPINE 5 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (white to off white) 11 mm ML;22 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33342-015-10 90 in 1 BOTTLE
2 NDC:33342-015-12 100 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201380 2012-04-13


Amlodipine

Amlodipine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:33342-016
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
amlodipine besylate AMLODIPINE 10 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (white to off white) 11 mm ML;23 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33342-016-10 90 in 1 BOTTLE
2 NDC:33342-016-12 100 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201380 2012-04-13


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