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IMPORTANT PRODUCT INFORMATION

HYZAAR is indicated for the treatment of hypertension. This fixed-dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients.

HYZAAR is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to black patients.

Selected important cautionary information

HYZAAR is contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide (HCTZ) component, HYZAAR is also contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

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, HYZAAR should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

HYZAAR is not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min). HYZAAR is not recommended as a means of titration for patients with hepatic impairment because the appropriate 25-mg starting dose of losartan cannot be given. In patients who are volume-depleted (eg, those treated with diuretics), symptomatic hypotension may occur after initiation of therapy with HYZAAR. This condition should be corrected prior to administration of HYZAAR.

The most common adverse events occurring with various doses of losartan/HCTZ (n = 858) at a rate >1% above placebo (n = 173) were upper respiratory infection (6% vs 5%), dizziness (6% vs 3%), back pain (2% vs 1%), palpitations (1% vs 0%), and rash (1% vs 0%).

Before prescribing HYZAAR, please read the Prescribing Information and Patient Product Information.