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Megace ES

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Megace ES

Indications
Dosage
How Supplied

INDICATIONS

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).

DOSAGE AND ADMINISTRATION

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) Megace-es (Megestrol acetate)  teaspoon (dosing cup) Megace-es (Megestrol acetate)  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.

HOW SUPPLIED

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.

NDC 49884-949-69 Bottles of 150 mL (5 fl. oz.)
NDC 49884-949-52 Unit Dose Bottles of 5 mL (0.17 fl. Oz.)-Institutional Use Only

 

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.

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Megace ES - User Reviews

Megace ES User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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