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 (seeCLINICAL 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 0006-0951-28 unit dose packages of 100

NDC 0006-0951-82 bottles of 1,000

NDC 0006-0951-87 bottles of 10,000.

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:

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

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

NDC 0006-0952-28 unit dose packages of 100

NDC 0006-0952-82 bottles of 1,000

NDC 0006-0952-87 bottles of 10,000.

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 0006-0960-28 unit dose packages of 100

NDC 0006-0960-82 bottles of 1,000

NDC 0006-0960-86 bottles of 5,000.

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.

Manufactured for:

Merck & CO., INC., Whitehouse Station, NJ 08889, USA

Issued September 2008

9573532

Printed in USA

Supplemental Patient Material

Patient Package Insert
Patient Information

COZAAR®(CO-zar)

(losartan potassium tablets)

25mg, 50mg, 100mg

Rx only

Read the Patient Information that comes with COZAAR1 before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition and treatment.

What is the most important information I should know about COZAAR?
Do not take COZAAR if you are pregnant or plan to become pregnant. COZAAR can harm your unborn baby causing injury and even death. Stop taking COZAAR if you become pregnant and call your doctor right away. If you plan to become pregnant, talk to your doctor about other treatment options before taking COZAAR.

What is COZAAR?
COZAAR is a prescription medicine called an angiotensin receptor blocker (ARB). It is used:

 
alone or with other blood pressure medicines to lower high blood pressure (hypertension).
 
to lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy. COZAAR may not help Black patients with this problem.
 
to slow the worsening of diabetic kidney disease (nephropathy) in patients with type 2 diabetes who have or had high blood pressure.

COZAAR has not been studied in children less than 6 years old or in children with certain kidney problems.

High Blood Pressure (hypertension). Blood pressure is the force in yo