Megace® ES (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).

The recommended adult initial dosage of Megace® ES (megestrol acetate) oral suspension is 625 mg/day (5 mL/day or one teaspoon daily). Please refer to the table below for correct dosing and administration. Shake container well before using.

PRODUCT DIFFERENCES
	Megace® ES Oral Suspension		Megace® and other megestrol acetate oral suspensions
mg/mL	125 mg/mL		40 mg/mL
Recommended Daily Dose	625 mg		800 mg
Daily VolumeIntake	5 mL		20 mL
	(teaspoon)		(dosing cup)
Formulation	Concentrated formula		Regular formula

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day of megestrol acetate oral suspension (800 mg/20 mL equivalent to 625 mg/5 mL of Megace® ES formula) were found to be clinically effective.

Megace® ES (megestrol acetate) oral suspension is a concentrated formula available as a milky white, lemon-lime flavored oral suspension containing 125 mg of megestrol acetate per mL.

Storage

Store Megace® ES (megestrol acetate) oral suspension between 15°-25° C (59°-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 sections). Women at risk of pregnancy should avoid such exposure.

Manufactured by:
PAR PHARMACEUTICAL COMPANIES, INC.
Spring Valley, New York 10977
www.MegaceES.com
Megace® is a registered trademark of Bristol-Myers Squibb Company licensed to Par Pharmaceutical, Inc.
FDA rev date: 8/12/2008.

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