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Cozaar (Losartan Potassium) - Summary

 

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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 SUMMARY

COZAAR (losartan potassium) is an angiotensin II receptor (type AT1) antagonist.

COZAAR is indicated for the following:

Hypertension

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

Hypertensive Patients with Left Ventricular Hypertrophy

COZAAR 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. (See PRECAUTIONS, Race and CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race.)

Nephropathy in Type 2 Diabetic 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) (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects).

COZAAR NEWS HIGHLIGHTS

Published Studies Related to Cozaar (Losartan)

Effect of Pentoxifylline in Addition to Losartan on Proteinuria and GFR in CKD: A 12-Month Randomized Trial. [2008.07.08]

Aliskiren combined with losartan in type 2 diabetes and nephropathy. [2008.06.05]

Laboratory tests as predictors of the antihypertensive effects of amlodipine, bisoprolol, hydrochlorothiazide and losartan in men: results from the randomized, double-blind, crossover GENRES Study. [2008.06]

Left bundle branch block and cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy: the Losartan Intervention For Endpoint Reduction in Hypertension study. [2008.06]

Meta-analysis of randomized controlled trials comparing telmisartan with losartan in the treatment of patients with hypertension. [2008.05]

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Clinical Trials Related to Cozaar (Losartan)

Losartan Therapy in Pulmonary Hypertension [Completed]

An Open Label Study to Assess the Efficacy, Safety and Tolerability of COZAAR Plus (Losartan Potassium 50mg/Hydrochlorothiazide 12.5mg) Possibly Titrated up to COZAAR Plus-F (Losartan Potassium 100mg/Hydrochlorothiazide 25mg) in Patients With Essential Hypertension [Terminated]

A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension [Terminated]

A Prospective, Randomised, Double-Blind, Double-Dummy, Forced-Titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study) [Completed]

Losartan in Hypertensive Men With Sleep Apnea Before and on Continuous Positive Airway Pressure (CPAP) Treatment [Recruiting]

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Page last updated: 2008-08-10

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