Country: United States
Language: English
Source: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)
Rising Pharmaceuticals, Inc.
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 pha
2.5 mg Tablets Amlodipine Besylate Tablets USP, 2.5 mg (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are white to off-white, flat, bevel edged round uncoated tablets, debossed with ‘C’ on one side and ‘57’ on the other side, and is supplied as follows: Bottles of 90 NDC 64980-390-09 Bottles of 500 NDC 64980-390-50 Bottles of 1,000 NDC 64980-390-10 5 mg Tablets Amlodipine Besylate Tablets USP, 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white to off-white, flat, bevel edged barrel shaped uncoated tablets, debossed with ‘C’ on one side and ‘58’ on the other side, and is supplied as follows: Bottles of 90 NDC 64980-391-09 Bottles of 500 NDC 64980-391-50 Bottles of 1,000 NDC 64980-391-10 10 mg Tablets Amlodipine Besylate Tablets USP, 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white to off-white, flat, bevel edged round uncoated tablets, debossed with ‘C’ on one side and ‘59’ on the other side, and is supplied as follows: Bottles of 90 NDC 64980-392-09 Bottles of 500 NDC 64980-392-50 Bottles of 1,000 NDC 64980-392-10 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in the USP. Distributed by: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Made in India Code: TS/DRUGS/19/1993 Issued: 05/2017
Abbreviated New Drug Application
AMLODIPINE BESYLATE - AMLODIPINE BESYLATE TABLET RISING PHARMACEUTICALS, 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, FOR ORAL USE 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: 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 (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, 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 aml Read the complete document