Cozaar - Indications & Dosage

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Hypertensive Patients with Left Ventricular Hypertrophy

The usual starting dose is 50 mg of COZAAR once daily. Hydrochlorothiazide 12.5 mg daily should be added and/ or the dose of COZAAR should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke).

Nephropathy in Type 2 Diabetic Patients

The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Nephropathy in Type 2 Diabetic Patients). COZAAR may be administered with insulin and other commonly used hypoglycemic agents (e. g., sulfonylureas, glitazones and glucosidase inhibitors).

HOW SUPPLIED

No. 3612 — Tablets COZAAR, 25 mg, are light green, teardrop-shaped, film-coated tablets with code MRK on one side and 951 on the other. They are supplied as follows:

NDC 0006-0951-54 unit of use bottles of 90

NDC 0006-0951-58 unit of use bottles of 100

NDC 0006-0951-28 unit dose packages of 100

NDC 0006-0951-82 bottles of 1,000. No. 3613 — Tablets COZAAR, 50 mg, are green, teardrop-shaped, film-coated tablets with code

MRK 952 on one side and COZAAR on the other. They are supplied as follows:

COZAAR ® (Losartan Potassium Tablets) 9573524

NDC 0006-0952-31 unit of use bottles of 30

NDC 0006-0952-54 unit of use bottles of 90

NDC 0006-0952-58 unit of use bottles of 100

NDC 0006-0952-28 unit dose packages of 100

NDC 0006-0952-82 bottles of 1,000. No. 6536 — Tablets COZAAR, 100 mg, are dark green, teardrop-shaped, film-coated tablets with code

960 on one side and MRK on the other. They are supplied as follows:

NDC 0006-0960-31 unit of use bottles of 30

NDC 0006-0960-54 unit of use bottles of 90

NDC 0006-0960-58 unit of use bottles of 100

NDC 0006-0960-28 unit dose packages of 100

NDC 0006-0960-82 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 August 2003 Printed in USA