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)
Micro Labs Limited
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 (CV) 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 Pre
Amlodipine and olmesartan medoxomil tablets contain amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil in the strengths described below. Amlodipine and olmesartan medoxomil tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Amlodipine and olmesartan medoxomil tablets are supplied for oral administration in the following strength and package configurations: Tablet Strength 5/20 mg Amlodipine and Olmesartan medoxomil tablets are white colored, round shaped, biconvex, film-coated tablet debossed with ‘81’ on one side and ‘I’ on other side and contain 5 mg Amlodipine and 20 mg Olmesartan medoxomil. They are supplied in Bottles of 30 NDC 42571-235-30 Bottles of 90 NDC 42571-235-90 Bottles of 500 NDC 42571-235-05 Bottles of 1000 NDC 42571-235-10 Tablet Strength 10/20 mg Amlodipine and Olmesartan medoxomil tablets are grayish orange colored, round shaped, biconvex, film-coated tablet debossed with ‘83’ on one side and ‘I’ on other side and contain 10 mg Amlodipine and 20 mg Olmesartan medoxomil. They are supplied in Bottles of 30 NDC 42571-236-30 Bottles of 90 NDC 42571-236-90 Bottles of 500 NDC 42571-236-05 Bottles of 1000 NDC 42571-236-10 Tablet Strength 5/40 mg Amlodipine and Olmesartan medoxomil tablets are cream colored, round shaped, biconvex, film-coated tablet debossed with ‘82’ on one side and ‘I’ on other side and contain 5 mg Amlodipine and 40 mg Olmesartan medoxomil. They are supplied in Bottles of 30 NDC 42571-237-30 Bottles of 90 NDC 42571-237-90 Bottles of 500 NDC 42571-237-05 Bottles of 1000 NDC 42571-237-10 Tablet Strength 10/40 mg Amlodipine and Olmesartan medoxomil tablets are Brownish red colored, round shaped, biconvex, film-coated tablet debossed with ‘84’ on one side and ‘I’ on other side and contain 10 mg Amlodipine and 40 mg Olmesartan medoxomil. They are supplied in Bottles of 30 NDC 42571-238-30 Bottles of 90 NDC 42571-238-90 Bottles of 500 NDC 42571-238-05 Bottles of 1000 NDC 42571-238-10 Store at 25° C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
AMLODIPINE AND OLMESARTAN MEDOXOMIL- AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET MICRO LABS 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 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 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 tablet is a combination of amlodipine besylate, a dihydropyridine calcium channel blocker, and olmesartan medoxomil, an angiotensin II receptor blocker, 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: 5/20 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 occur upon d Read the complete document