Megace (Megestrol Acetate) - Indications and Dosage

INDICATIONS AND USAGE

MEGACE Oral Suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).

DOSAGE AND ADMINISTRATION

The recommended adult initial dosage of MEGACE Oral Suspension is 800 mg/day (20 mL/day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

A plastic dosage cup with 10 mL and 20 mL markings is provided for convenience.

HOW SUPPLIED

MEGACE^® (megestrol acetate, USP) Oral Suspension is available as a lemon-lime flavored oral suspension containing 40 mg of micronized megestrol acetate per mL.

          NDC 0015-0508-42 Bottles of 240 mL (8 fl. oz.)

STORAGE

Store MEGACE Oral Suspension between 15° C - 25° C (59° F - 77° F) and dispense in a tight container. Protect from heat.

SPECIAL HANDLING

Health Hazard Data

There is no threshold limit value established by OSHA, NIOSH, or ACGIH.

Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see WARNINGS and ADVERSE REACTIONS). Women at risk of pregnancy should avoid such exposure.

Distributed by:
Bristol-Myers Squibb Company
Princeton, New Jersey 08543 USA

51-029626-01
Revised March 2007