Hypertension
COZAAR and HYZAAR are indicated for the treatment of hypertension. COZAAR may be used alone or in combination with other antihypertensive agents, including diuretics. HYZAAR is not indicated for initial therapy of hypertension, except when the hypertension
Stroke Risk Reduction
COZAAR and HYZAAR are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (LVH), but there is evidence that this benefit does not apply to black patients.
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 and HYZAAR should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
COZAAR and HYZAAR are contraindicated in patients who are hypersensitive to any component of these products. Because of the hydrochlorothiazide (HCTZ) component, HYZAAR is also contraindicated in patients with anuria or hypersensitivity to other
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.
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 25-mg starting dose of COZAAR 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.
Angioedema, which may cause airway obstruction, has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported with losartan. Anaphylactic reactions have been reported.
Before prescribing COZAAR and HYZAAR, please read the Prescribing Information.
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COZAAR and HYZAAR are registered trademarks of E.I. du Pont de Nemours and Company, Wilmington, Delaware, USA.
20952504(3)-12/09-COZ
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