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Aldosterone Blocker Approved as Hypertension Treatment

Cheryl A. Thompson

Pharmacia Corp. announced this morning that the Food and Drug Administration approved the marketing of eplerenone for the treatment of hypertension.

According to the company, eplerenone is the first drug designed to selectively block aldosterone at its receptors.

Pharmacia stated that eplerenone was effective, with or without other antihypertensives, in lowering patients' high blood pressure during the clinical studies and that, in the studies of eplerenone versus placebo, the new agent had an overall adverse-event profile similar to placebo. Eplerenone is contraindicated in patients with a high potassium level, renal insufficiency, or diabetes mellitus associated with microalbuminuria or who are taking a potassium supplement or potassium-sparing diuretic.

The company, which did not announce a date of availability for the new product, will sell eplerenone tablets under the brand name Inspra. 

Update 2 October 2002—Inspra (PDF) will be available in 25-, 50-, and 100-mg tablets in 30- and 90-count bottles and in unit dose packages. The product's labeling states that the recommended starting dosage is 50 mg once daily. A company spokesman said the product will be shipped to pharmacies in early 2003.