AMLODIPINE BESYLATE description, usages, side effects, indications, overdosage, supplying and lots more!

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AMLODIPINE BESYLATE

Wockhardt Limited

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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. Approval: 1987 INDICATIONS AND USAGE Hypertension (1.1) Coronary Artery Disease (1.2) Chronic Stable Angina Vasospastic Angina (Prinzmetal’s or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% DOSAGE AND ADMINISTRATION Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. (2.1) Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. (2.1) Pediatric starting dose: 2.5 mg to 5 mg once daily. (2.2) Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients. (2.2)DOSAGE FORMS AND STRENGTHS 2.5 mg, 5 mg, and 10 mg Tablets (3) CONTRAINDICATIONS Known sensitivity to amlodipine (4) WARNINGS AND PRECAUTIONS Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, because of the gradual onset of action, 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 when administering calcium channel blockers to patients with severe hepatic impairment. (5.4) Side EffectsTo report SUSPECTED ADVERSE REACTIONS, contact Wockhardt USA LLC. at 1-800-346-6854 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .USE IN SPECIFIC POPULATIONS Pregnancy: Use only if the potential benefit justifies the potential risk. (8.1) Nursing: Discontinue when administering amlodipine besylate. (8.3) Pediatric: Effect on patients less than 6 years old is not known. (8.4) Geriatric: Start dosing at the low end of the dose range, due to the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. (8.5)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE


1.1 Hypertension

1.2 Coronary Artery Disease (CAD)

Chronic Stable Angina


Vasospastic Angina (Prinzmetal's or Variant Angina)


Angiographically Documented CAD

2 DOSAGE AND ADMINISTRATION


2.1 Adults







[see Adverse Reactions (6)].

[see Clinical Studies (14.4)].

2.2 Children

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

3 DOSAGE FORMS AND STRENGTHS


4 CONTRAINDICATIONS


5 WARNINGS AND PRECAUTIONS


5.1 Hypotension

5.2 Increased Angina or Myocardial Infarction


5.3 Beta-Blocker Withdrawal


5.4 Patients with Hepatic Failure

1/2

6 ADVERSE REACTIONS


6.1 Clinical Trials Experience




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

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:

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

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:


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


Cardiovascular:

Central and Peripheral Nervous System:

Gastrointestinal:1

General:1

Musculoskeletal System: 1

Psychiatric:1

Respiratory System: 1

Skin and Appendages: 11

Special Senses:

Urinary System:

Autonomic Nervous System:

Metabolic and Nutritional:

Hemopoietic:

1







[see Clinical Studies (14.4)]

6.2 Postmarketing Experience






7 DRUG INTERACTIONS


7.1 Data

In vitro

7.2 Cimetidine


7.3 Grapefruit Juice



7.4 Magnesium and Aluminum Hydroxide Antacid


7.5 Sildenafil

7.6 Atorvastatin


7.7 Digoxin

7.8 Ethanol (Alcohol)


7.9 Warfarin


7.10 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

[see Dosage and Administration (2.1)].

10 OVERDOSAGE



2


11 DESCRIPTION



202525663
AMLODIPINE BESYLATE

12 CLINICAL PHARMACOLOGY


12.1 Mechanism of Action

in vitro







in vitro

12.2 Pharmacodynamics









12.3 Pharmacokinetics and Metabolism



Ex vivo




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 Besylate versus Placebo
AMLODIPINE BESYLATE
Figure 2  Effects on Primary Endpoint of Amlodipine Besylate versus Placebo across Sub-Groups
AMLODIPINE BESYLATE

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)

14.5 Studies in Patients with Heart Failure




16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 2.5 mg Tablets





16.2 5 mg Tablets






16.3 10 mg Tablets






16.4 Storage



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Amlodipine Besylate Tablets
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What are amlodipine besylate tablets?
Amlodipine besylate tablets

High Blood Pressure (hypertension)
Amlodipine besylate tablets

Angina
Amlodipine besylate tablets

Who should not use amlodipine besylate tablets?
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What should I tell my doctor before taking amlodipine besylate tablets?

  • ever had heart disease
  • ever had liver problems
  • are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablets are the best treatment for you.
  • are breast-feeding. Do not breast-feed while taking amlodipine besylate tablets. You can stop breast-feeding or take a different medicine.
How should I take amlodipine besylate tablets?
  • Take amlodipine besylate tablets once a day, with or without food. You can take amlodipine besylate tablets with most drinks, including grapefruit juice.
  • It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not take more than one dose of amlodipine besylate tablets at a time.
  • If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate tablets if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time.
  • Other medicines: You can use nitroglycerin and amlodipine besylate tablets together. If you take nitroglycerin for angina, don't stop taking it while you are taking a mlodipine besylate tablets.
  • While you are taking amlodipine besylate tablets, do not stop taking your other prescription medicines, including any other blood pressure medicines, without talking to your doctor.
  • If you took too much amlodipine besylate tablets, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.
What should I avoid while taking amlodipine besylate tablets?
  • Do not breast-feed. It is not known if amlodipine besylate tablets will pass through your milk.
  • Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.
What are the possible side effects of amlodipine besylate tablets?
Amlodipine besylate tablets

  • headache
  • swelling of your legs or ankles
  • tiredness, extreme sleepiness
  • stomach pain, nausea
  • dizziness
  • flushing (hot or warm feeling in your face)
  • arrhythmia (irregular heartbeat)
  • heart palpitations (very fast heartbeat)
amlodipine besylate tablets

amlodipine besylate tablets

How do I store amlodipine besylate tablets?
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General advice about amlodipine besylate tablets
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amlodipine besylate tablets

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AMLODIPINE BESYLATE AMLODIPINE BESYLATE AMLODIPINE BESYLATE

AMLODIPINE BESYLATE

AMLODIPINE BESYLATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55648-421
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
amlodipine besylate AMLODIPINE 2.5 mg

Inactive Ingredients

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

Product Characteristics

Color Size Imprint Code Shape
white (White to off-white) 8 mm W;421 TRIANGLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55648-421-01 90 in 1 BOTTLE
2 NDC:55648-421-02 1000 in 1 BOTTLE
3 10 in 1 BLISTER PACK
4 NDC:55648-421-04 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078500 2007-09-06


AMLODIPINE BESYLATE

AMLODIPINE BESYLATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55648-422
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
SODIUM STARCH GLYCOLATE TYPE A POTATO
mannitol
cellulose, microcrystalline
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
COLLOIDAL SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
white (white to off-white) 9 mm W;422 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55648-422-01 90 in 1 BOTTLE
2 NDC:55648-422-02 1000 in 1 BOTTLE
3 10 in 1 BLISTER PACK
4 NDC:55648-422-04 100 in 1 BOTTLE
5 NDC:55648-422-05 300 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078500 2007-09-06


AMLODIPINE BESYLATE

AMLODIPINE BESYLATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55648-423
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
SODIUM STARCH GLYCOLATE TYPE A POTATO
mannitol
cellulose, microcrystalline
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
COLLOIDAL SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
white 11 mm W423 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55648-423-01 90 in 1 BOTTLE
2 NDC:55648-423-02 1000 in 1 BOTTLE
3 10 in 1 BLISTER PACK
4 NDC:55648-423-04 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078500 2007-09-06


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