البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)
Mylan Institutional Inc.
AMLODIPINE BESYLATE
AMLODIPINE 2.5 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET MYLAN INSTITUTIONAL INC. ---------- 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 اقرأ الوثيقة كاملة