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  • Megace ES
    (Megestrol Acetate) - Par

    OTHER BRAND NAMES

    Megace (Bristol-Myers Squibb)

    THERAPEUTIC CLASS

    Progesterone

    DEA CLASS

    RX

    INDICATIONS

    Treatment of anorexia, cachexia, or an unexplained, significant weight loss in AIDS patients.

    ADULT DOSAGE

    Adults: (Megace) Initial: 800mg/day (20mL/day). Effective Dose Range: 400-800mg/day. (Megace ES) Initial: 625mg/day (5mL/day).

    HOW SUPPLIED

    Sus: (Megace) 40mg/mL [240mL]; (Megace ES) 125mg/mL [150mL]

    CONTRAINDICATIONS

    Known or suspected pregnancy.

    WARNINGS/PRECAUTIONS

    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 Adrenal insufficiency reported in patients receiving or being withdrawn from chronic therapy; laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are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.

    ADVERSE REACTIONS

    Diarrhea, impotence, rash, flatulence, nausea, HTN, asthenia, insomnia, anemia, fever, decreased libido, dyspepsia, headache, hyperglycemia.

    DRUG INTERACTIONS

    (Megace ES) May decrease exposure of indinavir; consider higher dose of indinavir.

    PREGNANCY

    Category X, not for use in nursing.

    MECHANISM OF ACTION

    Progesterone; has not been established; has appetite-enhancing property.

    PHARMACOKINETICS

    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.

    ASSESSMENT

    Assess for preexisting DM, history of thromboembolic disease, hypersensitivity to drug, pregnancy/nursing status and for possible drug interactions.

    MONITORING

    Monitor for new/worsening DM, Cushing's syndrome, vaginal bleeding, and adrenal insufficiency.

    PATIENT COUNSELING

    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/STORAGE

    Administration: Oral route. Shake well before use. (Megace ES) Take without regard to meals. Storage: 15-25°C (59-77°F). Protect from heat.