Benicar is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Dosage must be individualized. The usual recommended starting dose of Benicar is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.

No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance < 40mL/min) or with moderate to marked hepatic dysfunction (see CLINICAL PHARMACOLOGY, Special Populations). For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), Benicar should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see WARNINGS, Hypotension in Volume- and Salt-Depleted Patients).

Benicar may be administered with or without food.

If blood pressure is not controlled by Benicar alone, a diuretic may be added. Benicar may be administered with other antihypertensive agents.

HOW SUPPLIED

Benicar is supplied as yellow, round, film-coated tablets containing 5 mg of olmesartan medoxomil, as white, round, film-coated tablets containing 20 mg of olmesartan medoxomil, and as white, oval-shaped, film-coated tablets containing 40 mg of olmesartan medoxomil. Tablets are debossed with Sankyo on one side and C12, C14, or C15 on the other side of the 5, 20, and 40 mg tablets, respectively.

Storage

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].

Manufactured by Sankyo Pharma GmbH, Munich, Germany Manufactured for Sankyo Pharma Inc., Parsippany, New Jersey 07054
Copyright © Sankyo Pharma Inc. 2004.
All rights reserved. Revised December 2004
FDA Rev. date: 7/13/2005

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