IMPORTANT PRODUCT INFORMATION:

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

COZAAR is 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.

COZAAR is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio >300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, COZAAR reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation).

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.

Electrolyte imbalances are common in patients with renal impairment with or without diabetes and should be addressed. In a clinical study of patients with type 2 diabetes, nephropathy, and hypertension, the incidence of hyperkalemia was higher in the group treated with COZAAR as compared to the placebo group; however, few patients discontinued therapy due to hyperkalemia.

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. Anaphalactic reactions have been reported.

In 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 in a clinical study in patients with type 2 diabetes, nephropathy, and hypertension reported with an incidence of >4% of patients treated with COZAAR (n = 751) and occurring at a rate of >4% above placebo (n = 762) on a background of conventional antihypertensive therapy were diarrhea (15% vs 10%), asthenia/fatigue (14% vs 10%), hypoglycemia (14% vs 10%), chest pain (12% vs 8%), hyperkalemia (7% vs 3%), and hypotension (7% vs 3%).

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