苯磺酸氨氯地平片英文说明书

HIGHLIGHTS OF PRESCRIBING INFORMATION

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 Initial U.S. Approval: 1987

INDICATIONS AND USAGE

Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

•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

: Doses in excess of 5 mg daily have not been studied in pediatric patients. ( ) Important Limitation2.2

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, 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

ADVERSE REACTIONS

Most common adverse reactions are headache and edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1% are headache, fatigue, nausea, abdominal pain, and somnolence. ( ) 6

To report SUSPECTED ADVERSE REACTIONS, contact Qualitest Pharmaceuticals at 1-800-444-4011 or FDA at 1-800-FDA-1088 or /medwatch.

To report SUSPECTED ADVERSE REACTIONS, contact at or FDA at 1-800-FDA-1088 or /medwatch

USE IN SPECIFIC POPULATIONS •Pregnancy: Use only if the potential benefit justifies the potential risk. ( ) 8.1

•Nursing: Discontinue when administering amlodipine. ( ) 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

Revised: 05/2010

FULL PRESCRIBING INFORMATION: CONTENTS *

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

7.10 Drug/Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

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

14 CLINICAL STUDIES

AMLODIPINE 5MG TABLET

* Sections or subsections omitted from the full prescribing information are not listed