Country: United States
Language: English
Source: NLM (National Library of Medicine)
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)
Mylan Institutional Inc.
OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL 20 mg
ORAL
PRESCRIPTION DRUG
Olmesartan medoxomil 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with 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 Education Program’s Joint National Committee on Prevention, Detection, Eva
Olmesartan Medoxomil Tablets are available containing 20 mg or 40 mg of olmesartan medoxomil, USP. The 20 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 112 on the other side. They are available as follows: NDC 42292-036-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). The 40 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 124 on the other side. They are available as follows: NDC 42292-037-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
OLMESARTAN MEDOXOMIL- OLMESARTAN MEDOXOMIL TABLET, FILM COATED MYLAN INSTITUTIONAL INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OLMESARTAN MEDOXOMIL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2002 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE 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 ( 5.6) 11/2016 INDICATIONS AND USAGE Olmesartan medoxomil tablets are an angiotensin II receptor blocker (ARB) 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). DOSAGE AND ADMINISTRATION INDIC ATIO N STARTING DOSE DOSE RANGE Adult Hypertension ( 2.1) 20 mg once daily 20 mg to 40 mg once daily Pediatric Hypertension (6 to 16 years) ( 2.2) 20 to < 35 kg 10 mg once daily ≥ 35 kg 20 mg once daily 20 to < 35 kg 10 mg to 20 mg once daily ≥ 35 kg 20 mg to 40 mg once daily Olmesartan medoxomil tablets may be administered with or without food. If blood pressure is not controlled by olmesartan medoxomil tablets alone, a diuretic may be added. Olmesartan medoxomil tablets may be administered with other antihypertensive agents. DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 20 mg, and 40 mg ( 3). CONTRAINDICATIONS Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes ( 4). WARNINGS AND PRECAUTIONS Avoid fetal ( _in utero_) exposure ( 5.1). Children < 1 year of age must not receive olmesartan medoxomil tablets for hypertension ( 5.2). Observe for signs and symptoms of Read the complete document