מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
AMLODIPINE (UNII: 1J444QC288) (AMLODIPINE - UNII:1J444QC288), OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)
Torrent Pharmaceuticals Limited
AMLODIPINE
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 contain amlodipine besylate, USP at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil, USP in the strengths described below. Amlodipine and olmesartan medoxomil tablets are differentiated by tablet color/size. Amlodipine and olmesartan medoxomil tablets are supplied for oral administration in the following strength and package configurations: Amlodipine and olmesartan medoxomil tablets 5/20 mg are white to off white, round, film coated tablets debossed with "24" on one side and plain on the other side. Bottles of 30 NDC 13668-324-30 Bottles of 90 NDC 13668-324-90 Bottles of 500 NDC 13668-324-05 Bottles of 1,000 NDC 13668-324-10 Amlodipine and olmesartan medoxomil tablets 10/20 mg are pale orange to light brown, round, film coated tablets debossed with "72" on one side and plain on the other side. Bottles of 30 NDC 13668-312-30 Bottles of 90 NDC 13668-312-90 Bottles of 500 NDC 13668-312-05 Bottles of 1,000 NDC 13668-312-10 Amlodipine and olmesartan medoxomil tablets 5/40 mg are cream to yellow, round, film coated tablets debossed with "1313" on one side and plain on the other side. Bottles of 30 NDC 13668-313-30 Bottles of 90 NDC 13668-313-90 Bottles of 500 NDC 13668-313-05 Bottles of 1,000 NDC 13668-313-10 Amlodipine and olmesartan medoxomil tablets 10/40 mg are brownish red, round, film coated tablets debossed with "1311" on one side and plain on the other side. Bottles of 30 NDC 13668-311-30 Bottles of 90 NDC 13668-311-90 Bottles of 500 NDC 13668-311-05 Bottles of 1,000 NDC 13668-311-10 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
AMLODIPINE AND OLMESARTAN MEDOXOMIL- AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET TORRENT PHARMACEUTICALS LIMITED ---------- 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 RX ONLY 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, 8.1). DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS ( 5.1, 8.1). INDICATIONS AND USAGE Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and 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 (CV), 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: 5/20 mg once daily ( 2). Titrate as needed in two-week intervals up to a maximum of 10/40 mg once daily ( 2). DOSAGE FORMS AND STRENGTHS Tablets: (amlodipine/olmesartan medoxomil content) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg ( 3). CONTRAINDICATIONS Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes ( 4). WARNINGS AND PRECAUTIONS Anticipate hypotension in volume-or salt-depleted patients with treatment initiation. Start treatment under close supervision ( 5.2). Increased angina or myocardial infarction may occ קרא את המסמך השלם