Olmesartan

• Treatment of essential hypertension in adults. • Treatment of hypertension in children and adolescents from 6 to less than 18 years of age.

1 INDICATIONS & USAGE 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 Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

OLMESARTAN (olmesartan medoxomil) is indicated for the treatment of mild to moderate essential hypertension. OLMESARTAN may be used alone or in combination with thiazide diuretic.

Pediatrics Pediatrics (6–16 years of age):

Based on the data submitted and reviewed by Health Canada, the safety and efficacy of olmesartan medoxomil in pediatric patients has been established; therefore, Health Canada has authorized an indication for pediatric use. Antihypertensive effects of olmesartan medoxomil have been demonstrated in hypertensive pediatric patients aged 6 to 16 years.

Use of olmesartan medoxomil in this age group is supported by evidence from an adequate and well-controlled study of olmesartan medoxomil in pediatric patients (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Special Populations, ACTION AND CLINICAL PHARMACOLOGY, and CLINICAL TRIALS).

Geriatrics Geriatrics (≥65 years of age):