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Drugs reference index «Megestrol Acetate»

Megestrol Acetate

Megestrol Acetate

Pronunciation: (me-JES-trole AS-eh-tate)Class: Progestin

Trade Names:Megace- Suspension 40 mg/mL

Trade Names:Megace ES- Suspension 125 mg/mL

Trade Names:Megestrol- Tablets 20 mg- Tablets 40 mg

Apo-Megestrol (Canada)Megace OS (Canada)


Inhibits secretion of pituitary gonadotropins with a resultant decrease in estrogen secretion; exerts a direct cytotoxic effect on tumor cells; mechanism of effect on anorexia and cachexia is unknown.



C max is 10 to 56 ng/mL; T max is 1 to 3 h for tablets. C max is approximately 753 ng/mL, and T max is approximately 5 h for suspension.


The megestrol acetate metabolites are negligible.


The major route for elimination is urine; minor routes are feces and respiratory, as CO 2 . The t ½ is 13 to 104.9 h (mean, 34.2 h) for tablets.

Indications and Usage

Oral suspension

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


Palliative treatment of advanced inoperable, recurrent, or metastatic carcinoma of breast or endometrium.


Hypersensitivity to progestins or any component of these formulations; known or suspected pregnancy (suspension).

Dosage and Administration

Breast CancerAdults

PO 40 mg 4 times daily.

Endometrial CancerAdults

PO 40 to 320 mg/day in divided doses.

Anorexia, Cachexia, Unexplained Weight Loss in AIDS patientsAdults

PO 800 mg/day. PO 625 mg/day ( Megace ES ).

General Advice

  • Shake suspension well before using.


Store tablet in dry, cool place at room temperature (59° to 86°F).

Store suspension between 59° and 77°F. Dispense in tight container. Protect from light.

Drug Interactions


Elevated dofetilide plasma concentrations may occur. Do not use concurrently.


Coadministration results in a significant decrease in C max and AUC of indinavir.

Laboratory Test Interactions

None well documented.

Adverse Reactions


Hypertension (8%); cardiomyopathy, palpitation (1% to 3%); heart failure, thromboembolic phenomena, including pulmonary embolism and thrombophlebitis.


Headache (10%); asthenia (6%); abnormal thinking, confusion, convulsion, depression, hyperesthesia, neuropathy, paresthesia (1% to 3%); hot flashes, lethargy, malaise, mood changes.


Rash (2%); alopecia, pruritus, skin disorder, sweating, vesiculobullous rash (2%).


Amblyopia, pharyngitis (2%).


Diarrhea (15%); flatulence (10%); vomiting (6%); nausea (5%); dyspepsia (4%); abdominal pain or discomfort, constipation, dry mouth, increased salivation, oral moniliasis (1% to 3%).


Impotence (14%); decreased libido (5%); urinary frequency (2%); albuminemia, breakthrough bleeding, gynecomastia, urinary incontinence, UTI (1% to 3%).


Leukopenia (1% to 3%).


Anemia (5%); hepatomegaly (1% to 3%).


Hyperglycemia (6%); increased LDH, peripheral edema (1% to 3%); glucose intolerance.


Pneumonia (2%); cough, dyspnea, lung disorder (1% to 3%).


Fever, pain (6%); chest pain, edema, herpes, infection, moniliasis, sarcoma (1% to 3%); carpal tunnel syndrome, increased appetite, tumor flare, weight gain.




Category D .


Category X .


Excreted in breast milk.


Safety and efficacy not established.


Use with caution, usually starting at the low end of the dosage range because of the greater frequency of decreased cardiac, hepatic, or renal function, and concomitant diseases or other drug therapy.

Adrenal insufficiency

Adrenal insufficiency may occur in patients receiving or being withdrawn from chronic megestrol acetate therapy.

Cushing syndrome

Has occurred.

Diabetes mellitus

New onset diabetes mellitus and exacerbation of preexisting diabetes mellitus has occurred.

Thromboembolic disease

Use with caution in patients with history of thromboembolic disease.



No data.

Patient Information

  • Explain potential significance of breakthrough bleeding, irregular menstrual cycles, and possible lack of menstrual cycle. Tell patient to notify health care provider of heavy or continuous menstrual flow.
  • Encourage patients with diabetes to monitor blood glucose more frequently until effect on diabetes control has been determined.
  • Instruct patient to report these symptoms to health care provider: chest pain; clay-colored stools; dark urine; dyspnea; edema; jaundice; numbness in extremities; pain in calves of legs with redness, warmth, and swelling; sudden severe headache; visual disturbances.
  • Inform patient about the product differences in dosages. Depending on the indications for use, the various oral suspensions contain different amounts of megestrol acetate in 5 mL.
  • Instruct patient to report any adverse reactions.
  • Advise women of childbearing potential to use contraception and avoid becoming pregnant while taking this drug.

Copyright © 2009 Wolters Kluwer Health.

  • Megestrol MedFacts Consumer Leaflet (Wolters Kluwer)
  • Megestrol Prescribing Information (FDA)
  • Megace Prescribing Information (FDA)
  • Megace Advanced Consumer (Micromedex) - Includes Dosage Information
  • Megace Suspension MedFacts Consumer Leaflet (Wolters Kluwer)
  • Megace ES Prescribing Information (FDA)
  • Megace ES Suspension MedFacts Consumer Leaflet (Wolters Kluwer)
  • Megace ES Detailed Consumer Information (PDR)
  • Megace ES Consumer Overview

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