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AZOR(TM) Receives FDA Approval for Treatment of High Blood Pressure
Date:9/27/2007

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Hypotension in Volume- or Salt-Depleted Patients

In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with Benicar. Treatment should start under close medical supervision. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Impaired Renal Function

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected.

Adverse Events

The withdrawal rates due to adverse events (AEs) were similar with Benicar to placebo: (2.4% vs 2.7%). The incidence of AEs with Benicar was similar to placebo. The only AE that occurred in >1% of patients treated with BENICAR and more frequently than placebo was dizziness (3% vs 1%).

Dosing and Administration

No initial dosage adjustments are recommended with Benicar in elderly or in moderate to marked renal impairment*/hepatic dysfunction. In patients with possible depletion of intravascular volume (e.g., patients on diuretics, particularly with impaired renal function), Benicar should be initiated under close medical supervision and consideration given to use of a lower starting dose

About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd., Japan's second largest pharmaceutical company and a global lead
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SOURCE Daiichi Sankyo, Inc.
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