AMLODIPINE BESYLATE- amlodipine besylate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)

Available from:

West-Ward Pharmaceuticals Corp.

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine besylate tablets are indicated for the treatmnt of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes ncluding amlodipine besylate tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of igh Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic cl

Product summary:

Amlodipine Besylate Tablets USP 2.5 mg tablets are supplied as round, white, biconvex tablets debossed with product identification “54” over “513” on one side and plain on the other side. NDC 0054-0100-22: Bottle of 90 Tablets NDC 0054-0100-31: Bottle of 1,000 Tablets 5 mg tablets are supplied as round, white, biconvex tablets debossed with product identification “54” over “771” on one side and plain on the other side. NDC 0054-0101-22: Bottle of 90 Tablets NDC 0054-0101-28: Bottle of 300 Tablets NDC 0054-0101-31: Bottle of 1,000 Tablets 10 mg tablets are supplied as round, white, biconvex tablets debossed with product identification “54” over “233” on one side and plain on the other side. NDC 0054-0102-22: Bottle of 90 Tablets NDC 0054-0102-28: Bottle of 300 Tablets NDC 0054-0102-31: Bottle of 1,000 Tablets Storage Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from light. Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 10003559/12 Revised December 2017

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
WEST-WARD PHARMACEUTICALS CORP.
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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, FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1992
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:
•
•
DOSAGE AND ADMINISTRATION
•
•
IMPORTANT LIMITATION: Doses in excess of 5 mg daily have not been
studied in pediatric patients. (2.2)
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reaction to amlodipine is edema which occurred in
a dose related manner. Other adverse
experiences not dose related but reported with an incidence >1.0% are
fatigue, nausea, abdominal pain, and somnolence.
(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WEST-WARD
PHARMACEUTICALS CORP. AT 1-800-962-8364
OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
•
Hypertension (1.1)
•
Amlodipine besylate tablets are indicated for the treatment of
hypertension, to lower blood pressure. Lowering
blood pressure reduces the risk of fatal and nonfatal cardiovascular
events, primarily strokes and myocardial
infarctions .
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%
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)
Tablets: 2.5 mg, 5 mg, and 10 mg tablets (3)