Cozaar

[Losartan]

Special Populations

Pediatric:

Losartan pharmacokinetics have not been investigated in patients <18 years of age.

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Geriatric and Gender:

Losartan pharmacokinetics have been investigated in the elderly (65-75 years) and in both genders. Plasma concentrations of losartan and its active metabolite are similar in elderly and young hypertensives. Plasma concentrations of losartan were about twice as high in female hypertensives as male hypertensives, but concentrations of the active metabolite were similar in males and females. No dosage adjustment is necessary (see DOSAGE AND ADMINISTRATION).

Race

Pharmacokinetic differences due to race have not been studied. (see also PRECAUTIONS, Race and CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race).

Renal Insufficiency

Plasma concentrations of losartan are not altered in patients with creatinine clearance above 30 mL/ min. In patients with lower creatinine clearance, AUCs are about 50% greater and they are doubled in hemodialysis patients. Plasma concentrations of the active metabolite are notsignificantly altered in patients with renal impairment or in hemodialysis patients. Neither losartan nor its active metabolite can be removed by hemodialysis. No dosage adjustment is necessary for patients with renal impairment unless they are volume-depleted (see WARNINGS, Hypotension — Volume-Depleted Patients and DOSAGE AND ADMINISTRATION).

Hepatic Insufficiency

Following oral administration in patients with mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of losartan and its active metabolite were, respectively, 5-times and about 1.7-times those in young male volunteers. Compared to normal subjects the total plasma clearance of losartan in patients with hepatic insufficiency was about 50% lower and the oral bioavailability was about 2-times higher. A lower starting dose is recommended for patients with a history of hepatic impairment (see DOSAGE AND ADMINISTRATION).

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