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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: (ES) Initial: 625mg/day (5mL/day). (Megace) Initial: 800mg/day (20mL/day). Effective Dose: 400mg/day and 800mg/day. Elderly: Start at lower end of dosing range.

    HOW SUPPLIED

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

    CONTRAINDICATIONS

    Known or suspected pregnancy.

    WARNINGS/PRECAUTIONS

    Institute only after treatable causes of weight loss are sought and addressed. 125mg/mL strength is not substitutable with other strengths (eg, 40mg/mL). Overt Cushing's syndrome and asymptomatic pituitary-adrenal suppression reported with chronic use. Adrenal insufficiency reported in patients receiving or being withdrawn from chronic therapy; consider use of replacement or stress doses of a rapidly acting glucocorticoid. New onset diabetes mellitus (DM) and exacerbation of preexisting DM reported with chronic use. Breakthrough bleeding reported in women. Caution with history of thromboembolic disease and in elderly.

    ADVERSE REACTIONS

    Diarrhea, rash, flatulence, N/V, HTN, headache, pain, asthenia, insomnia, anemia, fever, decreased libido, impotence, hyperglycemia.

    DRUG INTERACTIONS

    (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 qd) Cmax=753ng/mL; AUC=10,476ng•hr/mL; Tmax=5 hrs (median). (750mg qd) Cmax=490ng/mL; AUC=6779ng•hr/mL; Tmax=3 hrs (median). Elimination: Urine (66.4%, 5-8% metabolites); feces (19.8%); (ES) T1/2=20-50 hrs.

    ASSESSMENT

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

    MONITORING

    Monitor for adrenal insufficiency, new onset/exacerbation of DM, vaginal bleeding, and other adverse reactions.

    PATIENT COUNSELING

    Inform about product differences to avoid overdosing or underdosing. Instruct to use ud. Advise to report any adverse reactions. Advise women of childbearing potential to use contraception while on therapy, and to notify physician if pregnancy occurs.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Shake well before use. Storage: 15-25°C (59-77°F). Protect from heat.