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:

Mylan Institutional Inc.

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine besylate tablets, USP 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including 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 High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmaco

Product summary:

Amlodipine Besylate Tablets, USP are available containing 2.5 mg, 5 mg or 10 mg of amlodipine base. 2.5 mg Tablets The 2.5 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and A8 on the other side. They are available as follows: NDC 51079-450-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 5 mg Tablets The 5 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and A9 on the other side. They are available as follows: NDC 51079-451-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-451-56 – Unit dose punch cards of 300 (10 punch cards of 30 tablets each). 10 mg Tablets The 10 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and A10 on the other side. They are available as follows: NDC 51079-452-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-452-56 – Unit dose punch cards of 300 (10 punch cards of 30 tablets each). Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
MYLAN INSTITUTIONAL INC.
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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, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Amlodipine is 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)
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%
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
Tablets: 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, 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 in patients with severe hepatic impairment. ( 5.3)
ADVERSE REACTIONS
Most common adverse reaction to amlodipine i