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Benicar (Olmesartan Medoxomil) - Indications and Dosage

 



INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

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.

Tablets are supplied as follows:

5 mg20 mg40 mg
Bottle of 30NDC 65597-101-30NDC 65597-103-30NDC 65597-104-30
Bottle of 90Not availableNDC 65597-103-90NDC 65597-104-90
Blister 10 cards X 10NDC 65597-103-10NDC 65597-104-10

Storage

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

Manufactured for Daiichi Sankyo, Inc., Parsippany, New Jersey  07054

Rx Only

Copyright © Daiichi Sankyo, Inc. 2006. All rights reserved.

P1800410       Rev. July 2007

Page last updated: 2008-06-24

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