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Selected safety information,
including boxed warning on use
in pregnancy.
Merck
COZAAR® (losartan potassium tablets)

Results in an analysis of 2 studies1

COZAAR: QD efficacy proven vs irbesartan.

In a combined analysis of 2 double-blind, 12-week studies with over 1,180 patients with mild to moderate hypertension, once-daily regimens of COZAAR were proven as effective as irbesartan. At Week 12, COZAAR 50 to 100 mg qd and irbesartan 150 to 300 mg qd provided mean SiDBP decreases of −8.3 mmHg and −9.4 mmHg, respectively.

Efficacy confirmed in an analysis of ARB trials

Over 8,000 patients included in an analysis from a pooled meta-analysis of randomized, controlled clinical trials*

Starting Doses & Titrated Doses
*
The above presentation does not include candesartan because the candesartan doses studied are not in the approved US label. Additionally, a comparison of these agents when hydrochlorothiazide was added has not been included in this presentation. The full meta-analysis contained 43 clinical trials.
 

Dosing considerations for COZAAR in patients with hypertension

Usual starting dose is COZAAR 50 mg once daily. The maximum daily dose is 100 mg.

If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.

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

Selected important cautionary information

USE IN PREGNANCY: When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, COZAAR should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

COZAAR is contraindicated in patients who are hypersensitive to any component of this product.

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. In patients with a history of hepatic impairment, a starting dose 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 hypertension trials with COZAAR, overall incidence of adverse events was similar to placebo. The most common adverse events with an incidence >2% of patients treated with COZAAR (n = 1,075) and occurring more commonly than placebo (n = 334) included upper respiratory infection (8% vs 7%), dizziness (3% vs 2%), nasal congestion (2% vs 1%), and back pain (2% vs 1%).

Before prescribing COZAAR, please read the Prescribing Information and Patient Information.

References: 1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP-127, PO Box 4, West Point, PA 19486-0004. Please specify information package DA-COZ50(2). 2. Conlin PR, Spence JD, Williams B, et al. Angiotensin II antagonists for hypertension: are there differences in efficacy? Am J Hypertens. 2000;13:418–426.

This site is intended only for health care professionals of the United States, its territories, and Puerto Rico.
COZAAR and HYZAAR® (losartan potassium-hydrochlorothiazide tablets) are registered trademarks of E.I. du Pont de Nemours and Company, Wilmington, Delaware, USA.
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