Megace
INDICATIONS
MEGACE (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 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.
A plastic dosage cup with 10 mL and 20 mL markings is provided for convenience.
HOW SUPPLIED
MEGACE ® Oral Suspension is available as a lemon- lime flavored oral suspension containing 40 mg of micronized megestrol acetate per mL.
| NDC 0015- 0508- 42 | Bottles of 240 mL (8 fl. oz.) |
Storage
Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F) [see USP Controlled Room Temperature]. Protect from temperatures above 40° C (104° F).
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). Women at risk of pregnancy should avoid such exposure.
Generic Name: Megestrol Acetate
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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