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6/11/2003

FDA Approves Benicar HCT as Hypertension Treatment

Kate Traynor

The Food and Drug Administration on June 5 approved the marketing of Benicar HCT for the second-line treatment of hypertension.

Benicar HCT (PDF) is a combination product containing the angiotensin II-receptor blocker olmesartan medoxomil and the diuretic hydrochlorothiazide. The product is comarketed by Sankyo Pharma Inc. and Forest Laboratories Inc. According to a Sankyo press release, the new product will be available in the second half of this year.

The most frequent adverse event associated with Benicar HCT is dizziness, which affected 9 percent of clinical trial patients who used the product. Other common adverse events are upper-respiratory-tract infection (7 percent), hyperuricemia (4 percent), and nausea (3 percent).

The product is contraindicated in patients whose urinary output has completely ceased or who have a hypersensitivity to a sulfonamide-derived drug. Use of Benicar HCT in patients who are volume or salt depleted should be closely monitored.

Benicar HCT tablets will be sold in three strengths: 20 mg of olmesartan medoxomil with 12.5 mg of hydrochlorothiazide; 40 mg of olmesartan medoxomil with 12.5 mg of hydrochlorothiazide; and 40 mg of olmesartan medoxomil with 25 mg of hydrochlorothiazide.