Country: United States
Language: English
Source: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)
Teva Pharmaceuticals USA, Inc.
AMLODIPINE BESYLATE
AMLODIPINE 5 mg
ORAL
PRESCRIPTION DRUG
Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil 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
Amlodipine and olmesartan medoxomil tablets are supplied for oral administration and contain amlodipine besylate, USP at a dose equivalent to 5 mg or 10 mg amlodipine and olmesartan medoxomil, USP in the strengths described below. 5 mg/20 mg: White, film-coated, modified capsule shaped tablet, debossed with “TV” on one side of the tablet and with “7027” on the other side of the tablet, in bottles of 30 (NDC 0093-7027-56) and 90 (NDC 0093-7027-98). 5 mg/40 mg: Light-yellow to yellow, film-coated, modified capsule shaped tablet, debossed with “TEVA” on one side of the tablet and with “7028” on the other side of the tablet, in bottles of 30 (NDC 0093-7028-56) and 90 (NDC 0093-7028-98). 10 mg/20 mg: Light-orange to orange, film-coated, modified capsule shaped tablet, debossed with “TEVA” on one side of the tablet and with “7029” on the other side of the tablet, in bottles of 30 (NDC 0093-7029-56) and 90 (NDC 0093-7029-98). 10 mg/40 mg: Red-brown, film-coated, modified capsule shaped tablet, debossed with “TEVA” on one side of the tablet and with “7030” on the other side of the tablet, in bottles of 30 (NDC 0093-7030-56) and 90 (NDC 0093-7030-98). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
AMLODIPINE AND OLMESARTAN MEDOXOMIL- AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2007 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS AS SOON AS POSSIBLE (5.1). DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS (5.1). RECENT MAJOR CHANGES Warnings and Precautions (5.7) 11/2016 INDICATIONS AND USAGE Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1). DOSAGE AND ADMINISTRATION Recommended starting dose: 5 mg/20 mg once daily (2). Titrate as needed in two week intervals up to a maximum of 10 mg/40 mg once daily (2). DOSAGE FORMS AND STRENGTHS Tablets: (amlodipine/olmesartan medoxomil content) 5 mg/20 mg; 10 mg/20 mg; 5 mg/40 mg; and 10 mg/40 mg (3). CONTRAINDICATIONS Do not coadminister aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes (4). WARNINGS AND PRECAUTIONS Hypotension in volume- or salt-depleted patients with treatment initiation may be anticipated. Start treatment under close Read the complete document