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