Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)
American Health Packaging
AMLODIPINE BESYLATE
AMLODIPINE 2.5 mg
ORAL
PRESCRIPTION DRUG
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. 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 pharmacologic
2.5 mg Tablets Amlodipine besylate-2.5 mg Tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat faced beveled edged tablets debossed with IG on one side and 237 on the other and supplied as follows: Unit dose packages of 100 (10 x 10) NDC 60687-285-01 5 mg Tablets Amlodipine besylate-5 mg Tablets (amlodipine besylate, USP equivalent to 5 mg of amlodipine per tablet) are supplied as white, round, flat faced beveled edged tablets debossed with IG on one side and 238 on the other and supplied as follows: Unit dose packages of 100 (10 x 10) NDC 60687-263-01 10 mg Tablets Amlodipine besylate-10 mg Tablets (amlodipine besylate, USP equivalent to 10 mg of amlodipine per tablet) are supplied as white, round, flat faced beveled edged tablets debossed with IG on one side and 239 on the other and supplied as follows: Unit dose packages of 100 (10 x 10) NDC 60687-274-01 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET AMERICAN HEALTH PACKAGING ---------- 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: 1987 INDICATIONS AND USAGE Amlodipine besylate 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 besylate tablets, 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 Olvassa el a teljes dokumentumot