Hyzaar

[Losartan/HCTZ]

Severe Hypertension

The starting dose of HYZAAR for initial treatment of severe hypertension is one tablet of HYZAAR 50-12.5 once daily (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). For patients who do not respond adequately to HYZAAR 50-12.5 after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of HYZAAR 100-25 once daily. The maximum dose is one tablet of HYZAAR 100-25 once daily. HYZAAR is not recommended as initial therapy in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given. It is also not recommended for use as initial therapy in patients with intravascular volume depletion (e. g., patients treated with diuretics, see WARNINGS, Hypotension— Volume-Depleted Patients).

HYZAAR may be administered with other antihypertensive agents. HYZAAR may be administered with or without food.

HOW SUPPLIED

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No. 3502 — Tablets HYZAAR, 50-12.5 are yellow, teardrop shaped, film-coated tablets, coded MRK 717 on one side and HYZAAR on the other. Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. They are supplied as follows:
NDC 0006-0717-31 unit of use bottles of 30
NDC 0006-0717-54 unit of use bottles of 90
NDC 0006-0717-58 unit of use bottles of 100
NDC 0006-0717-28 unit dose packages of 100
NDC 0006-0717-82 bottles of 1,000. No. 3793 — Tablets HYZAAR 100-25 are light yellow, teardrop shaped, film-coated tablets, coded MRK 747 on one side and HYZAAR on the other. Each tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. They are supplied as follows:
NDC 0006-0747-31 unit of use bottles of 30
NDC 0006-0747-54 unit of use bottles of 90
NDC 0006-0747-58 unit of use bottles of 100
NDC 0006-0747-28 unit dose packages of 100
NDC 0006-0747-82 bottles of 1,000.

Storage
Store at 25°C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

Issued September 2003 Printed in USA

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