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Megace (Bristol-Myers Squibb)
Treatment of anorexia, cachexia, or an unexplained, significant weight loss in AIDS patients.
Adults: (Megace) Initial: 800mg/day (20mL/day). Effective Dose Range: 400-800mg/day. (Megace ES) Initial: 625mg/day (5mL/day).
Sus: (Megace) 40mg/mL [240mL]; (Megace ES) 125mg/mL [150mL]
Known or suspected pregnancy.
May cause fetal harm when administered to a pregnant woman. Not for prophylactic use to avoid weight loss. New onset or exacerbation of preexisting diabetes mellitus (DM) and overt Cushing's syndrome reported with chronic use; may increase insulin requirements in patients with DM. Adrenal insufficiency reported in patients receiving or being withdrawn from chronic therapy; laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended. Caution with history of thromboembolic disease and in elderly. Institute only after treatable causes of weight loss are sought and addressed. Breakthrough bleeding reported in women.
Diarrhea, impotence, rash, flatulence, nausea, HTN, asthenia, insomnia, anemia, fever, decreased libido, dyspepsia, headache, hyperglycemia.
(Megace ES) May decrease exposure of indinavir; consider higher dose of indinavir.
Category X, not for use in nursing.
Progesterone; has not been established; has appetite-enhancing property.
Absorption: (800mg/day) Cmax=753ng/mL, AUC=10,476ng•hr/mL, Tmax=5 hrs (median). (750mg/day) Cmax=490ng/mL, AUC=6779ng•hr/mL, Tmax=3 hrs (median). Elimination: Urine (66.4%, 5%-8% metabolites), feces (19.8%); (Megace ES) T1/2=20-50 hrs.
Assess for preexisting DM, history of thromboembolic disease, hypersensitivity to drug, pregnancy/nursing status and for possible drug interactions.
Monitor for new/worsening DM, Cushing's syndrome, vaginal bleeding, and adrenal insufficiency.
Instruct to use ud. Inform about product differences to avoid overdosing or underdosing. Advise to report any adverse reactions. Advise to use contraception in woman capable of becoming pregnant and to notify physician if they become pregnant while on therapy.
Administration: Oral route. Shake well before use. (Megace ES) Take without regard to meals. Storage: 15-25°C (59-77°F). Protect from heat.