国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)
West-Ward Pharmaceuticals Corp.
AMLODIPINE BESYLATE
AMLODIPINE 2.5 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET WEST-WARD PHARMACEUTICALS CORP. ---------- 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) 完全なドキュメントを読む