Trade.Information

Product Name: HYZAAR® (Medicines)

Product Description

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 sulfonamide-derived drugs.

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.

The LIFE study does not provide evidence that the benefits of COZAAR and HYZAAR on reducing the risk of CV events in hypertensive patients with LVH apply to black patients.

In the LIFE study, adverse events with COZAAR were similar to those reported previously in patients with hypertension.

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%).

The most common adverse events occurring with various doses of losartan/HCTZ (n = 858) at a rate of >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%).

Company Details

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The company... more