Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)
Macleods Pharmaceuticals Limited
OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL 5 mg
ORAL
PRESCRIPTION DRUG
Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, 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
Olmesartan medoxomil tablets are supplied as yellow, round, biconvex, film-coated, non-scored tablets debossed with "C51" on one side and plain on other side containing 5 mg of olmesartan medoxomil, as white, round, biconvex, film-coated, non-scored tablets debossed with "C53" on one side and plain on other side containing 20 mg of olmesartan medoxomil and as white, oval, biconvex, film-coated, non-scored tablets debossed with "C54" on one side and plain on other side containing 40 mg of olmesartan medoxomil. Tablets are supplied as follows: 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].
Abbreviated New Drug Application
OLMESARTAN MEDOXOMIL - OLMESARTAN MEDOXOMIL TABLET MACLEODS PHARMACEUTICALS LIMITED ---------- 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, 8.1). • DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS (5.1, 8.1). RECENT MAJOR CHANGES Warnings and Precautions (5.3, 5.6) 10/2019 INDICATIONS AND USAGE Olmesartan medoxomil tablets are an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adult and pediatric patients six years of age and older, 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 INDICATION STARTING DOSE DOSE RANGE Adult Hypertension (2.1) 20 mg once daily 20 - 40 mg once daily Pediatric Hypertension (6 years of age and older) (2.2) 20 to <35 kg 10 mg once daily 20 to <35 kg 10 - 20 mg once daily ≥35 kg 20 mg once daily ≥35 kg 20 - 40 mg once daily DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 20 mg, and 40 mg (3). (3) CONTRAINDICATIONS Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes (4). (4) WARNINGS AND PRECAUTIONS • Avoid fetal (_in utero_) exposure (5.1). • Use of olmesartan medoxomil tablets in children <1 year of age is not recommended (5.2). • Observe for signs and symptoms of hypotension in volume- or salt-depleted patients with treatment initiation (5.3). • Monitor for worsening renal function in patients with renal impairment (5.4). • Sprue-like Läs hela dokumentet