Megestrol (Megestrol Acetate) - Indications and Dosage

INDICATIONS AND USAGE

Megestrol acetate 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 megestrol acetate 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.

HOW SUPPLIED

Megestrol acetate oral suspension is available as a milky white, lemon-lime flavored oral suspension containing 40 mg of micronized megestrol acetate per mL.

Bottles of 240 mL (8 fl. oz.)          NDC 54868-5389-0

Bottles of 480 mL (16 fl. oz.)        NDC 54868-5389-1

STORAGE

Store the oral suspension between 20°-25°C (68°-77°F). [See USP]. 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 sections). Women at risk of pregnancy should avoid such exposure.

Manufactured by:

PAR PHARMACEUTICAL COMPANIES, INC.

Spring Valley, NY 10977

Patent No.:

6,028,065

6,268,356

6,593,318

6,593,320

Revised: 12/09

Relabeling of "Additional" barcode label by:
Physicians Total Care, Inc.
Tulsa, OK       74146