HYZAAR® 100-12.5 mg Offers A New Convenient Dosing Option Within The Losartan Family; New Dosage Tablet Combines the Once-Daily Efficacy of COZAAR® 100 mg with a Low-Dose Diuretic

Business Wire, Oct 21, 2005

In patients who are volume-depleted, symptomatic hypotension may occur after initiation of therapy with COZAAR. This condition should be corrected prior to administration of COZAAR, or a dosage of COZAAR 25 mg should be used. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.

In other clinical trials with losartan for hypertension, the most common adverse events with an incidence greater or equal to two percent of patients treated with COZAAR (n=1,075) and occurring more commonly than placebo (n=334) included upper respiratory infection (8 percent for losartan vs. 7 percent for placebo), dizziness (3 percent for losartan vs. 2 percent for placebo), nasal congestion (2 percent for losartan vs. 1 percent for placebo), and back pain (2 percent for losartan vs. 1 percent for placebo).

In other clinical trials with losartan potassium-hydrochlorothiazide the most common adverse events occurring with various doses of losartan potassium-hydrochlorothiazide (n=858) at a rate of one percent or more above placebo (n=173) were upper respiratory infection (6 percent vs. 5 percent), dizziness (6 percent vs. 3 percent), back pain (2 percent vs. 1 percent), palpitations (1 percent vs. 0 percent) and rash (1 percent vs. 0 percent).

In other clinical trials with losartan potassium-hydrochlorothiazide, including the LIFE study, adverse events occurred at about the same rates in men and women. Adverse events were somewhat more frequent in the elderly compared to non-elderly patients and somewhat more frequent in blacks compared to non-blacks for both the losartan-hydrochlorothiazide and the control groups.

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