AMLODIPINE BESYLATE- amlodipine besylate tablet 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:

NCS HealthCare of KY, Inc dba Vangard Labs

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine besylate tablet, USP is 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 tablet, USP. 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 pharma

Product summary:

2.5 mg Tablets Amlodipine Besylate Tablets, USP - 2.5 mg (Amlodipine besylate USP equivalent to 2.5 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "126" debossed on one side and "C" on other side and supplied as follows: NDC 0615-7941-39    Blistercards of 30 NDC 0615-7941-30    Unit-Dose Boxes of 30      5 mg Tablets Amlodipine Besylate Tablets, USP - 5 mg (Amlodipine besylate USP equivalent to 5 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "127" debossed on one side and "C" on other side. NDC 0615-7942-39     Blistercards of 30 NDC 0615-7942-05     Blistercards of 15 NDC 0615-7942-30      Unit-Dose Boxes of 30       10 mg Tablets Amlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side. NDC 0615-7939-39     Blistercards of 30 NDC 0615-7939-05     Blistercards of 15 NDC 0615-7939-30     Unit-Dose Boxes of 30   Storage Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture. Manufactured by: Cipla, Ltd., Verna, Goa India Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156 Revised: 5/2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE 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: 1987
INDICATIONS AND USAGE
Amlodipine besylate tablet, USP 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)
o Amlodipine besylate tablet, USP is 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)
o Chronic Stable Angina
o Vasospastic Angina (Prinzmetal's or Variant Angina)
o 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)
o 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, acute hypotension is
unlikely. (5.1)
• Worsening angina and acute myocardial infarction can develop after
starting or increasing the dose of Amlodipine
besylate tablet, USP, particularly in patients with severe obstructive
coronary