Hyzaar

[Losartan/HCTZ]

Hydrochlorothiazide:

Following oral administration, the AUC for hydrochlorothiazide is increased by 70 and 700% for patients with mild and moderate renal insufficiency, respectively. In this study, renal clearance of hydrochlorothiazide decreased by 45 and 85% in patients with mild and moderate renal impairment, respectively. The usual regimens of therapy with HYZAAR may be followed as long as the patient's creatinine clearance is >30 mL/ min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so HYZAAR is not recommended. (See DOSAGE AND ADMINISTRATION.)

Hepatic Insufficiency

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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. The lower starting dose of losartan recommended for use in patients with hepatic impairment cannot be given using HYZAAR. Its use in such patients as a means of losartan titration is, therefore, not recommended (see DOSAGE AND ADMINISTRATION).

Drug Interactions

Losartan Potassium

Losartan, administered for 12 days, did not affect the pharmacokinetics or pharmacodynamics of a single dose of warfarin. Losartan did not affect the pharmacokinetics of oral or intravenous digoxin. There is no pharmacokinetic interaction between losartan and hydrochlorothiazide.

Coadministration of losartan and cimetidine led to an increase of about 18% in AUC of losartan but did not affect the pharmacokinetics of its active metabolite.

Coadministration of losartan and phenobarbital led to a reduction of about 20% in the AUC of losartan and that of its active metabolite. A somewhat greater interaction (approximately 40% reduction in the AUC of active metabolite and approximately 30% reduction in the AUC of losartan) has been reported with rifampin.

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