Country: United States
Language: English
Source: NLM (National Library of Medicine)
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)
A-S Medication Solutions
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 Join
Product: 50090-4451 NDC: 50090-4451-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-4451-1 90 TABLET, FILM COATED in a BOTTLE
Abbreviated New Drug Application
OLMESARTAN MEDOXOMIL- OLMESARTAN MEDOXOMIL TABLET, FILM COATED A-S MEDICATION SOLUTIONS ---------- 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._ • • RECENT MAJOR CHANGES 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 to 40 mg once daily Pediatric Hypertension (6 years of age and older) (2.2) 20 to < 35 kg 10 mg once daily >35 kg 20 mg once daily 20 to < 35 kg 10 to 20 mg once daily >35 kg 20 to 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). WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS The most common adverse reaction in adults was dizziness (3%) (6.1). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLENMARK PHARMACEUTICALS INC., USA AT 1 (888) 721-7115 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS WHEN PREGNANCY IS DETECTED, DISCONTINUE 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). Warnings and Precautions (5.3, 5.6) 10/2019 Avoid fetal (in utero) exposure (5.1). Use of olmesartan medoxomil children <1 year of Read the complete document