July 27, 2016
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Megace ES

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Megace ES




Indications
Dosage
How Supplied

INDICATIONS

Megace® ES 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).

Limitations Of Use

Other Treatable Causes

Therapy with megestrol acetate for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, renal disease or psychiatric diseases.

Prophylactic Use

Megestrol acetate is not intended for prophylactic use to avoid weight loss.

DOSAGE AND ADMINISTRATION

The recommended adult initial dosage of Megace® ES oral suspension is 625 mg/day (5 mL/day or one teaspoon daily). Shake the container well before using.

This strength (125 mg/mL) is not substitutable with other strengths (e.g., 40 mg/mL). Refer to the prescribing information of the 40 mg/mL product for dosage recommendations for the 40 mg/mL strength.

HOW SUPPLIED

Dosage Forms And Strengths

Megace® ES is a milky white, lemon-lime flavored oral suspension containing 125 mg of megestrol acetate per mL. Megace® ES does not contain the same amount of megestrol acetate as Megace® oral suspension or any of the other megestrol acetate oral suspensions.

Storage And Handling

Megace ES® oral suspension is a milky white, lemon-lime flavored oral suspension containing 125 mg of megestrol acetate per mL. Available in bottles of 150 mL (5 fl oz) NDC 49884 -94969.

Storage

Store Megace® ES oral suspension between 15° to 25° C (59° to 77° F) and dispense in a tight container. Protect from heat.

Safe 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 PRECAUTIONS and ADVERSE REACTIONS]. Women at risk of pregnancy should avoid such exposure.

Manufactured by: PAR PHARMACEUTICAL COMPANIES, INC., Spring Valley, New York 10977. Revised: Mar 2014.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 7/19/2016

Indications
Dosage
How Supplied

Megace ES - User Reviews

Megace ES User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Megace ES sorted by most helpful. Patient Discussions FAQs

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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