Megace ES is a man-made chemical similar to the female hormone progesterone.

Megace ES is used to treat loss of appetite and wasting syndrome in people with acquired immunodeficiency syndrome (AIDS).

Megace ES is not for use in preventing weight loss or wasting syndrome.

Do not use Megace ES if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you take Megace ES, tell your doctor if you have diabetes or a history of stroke or blood clot.

Your dosage needs may change if you have surgery, are ill, are under stress, or have an infection. Do not change your medication dose or schedule without your doctor's advice.

Take Megace ES exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

Your dosage needs may also change if you have surgery, are ill, are under stress, or have an infection. Do not change your medication dose or schedule without your doctor's advice.

Store at room temperature away from moisture and heat.

When you stop using Megace ES after long-term use, you may have withdrawal symptoms such as nausea, vomiting, dizziness, or weakness. Ask your doctor how to safely stop using this medicine.

Usual Adult Dose for Breast Cancer--Palliative:

Megestrol tablets are indicated for use in the palliative treatment of advanced carcinoma of the breast: 160 mg/day (40 mg of oral tablets four times a day)

Usual Adult Dose for Endometrial Carcinoma:

Megestrol tablets are indicated for use in the palliative treatment of advanced carcinoma of the endometrium: 40 to 320 mg/day of oral tablets in divided doses

Usual Adult Dose for Anorexia:

Megestrol oral suspension is indicated for use in the treatment of anorexia at a dose of 800 mg/day.

Alternatively, 625 mg/5 mL of the concentrated formula (Megace ES formula) may be given.

Note: 800 mg/20 mL of the regular formula is equivalent to 625 mg/ 5 mL of the concentrated formula.

Usual Adult Dose for Cachexia:

Megestrol oral suspension is indicated for use in the treatment of cachexia at a dose of 800 mg/day.

Alternatively, 625 mg/5 mL of the concentrated formula (Megace ES formula) may be given.

Note: 800 mg/20 mL of the regular formula is equivalent to 625 mg/ 5 mL of the concentrated formula.

Usual Adult Dose for Weight Loss:

Megestrol oral suspension is indicated for use in the treatment of unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS) at a dose of 800 mg/day.

Alternatively, 625 mg/5 mL of the concentrated formula (Megace ES formula) may be given.

Note: 800 mg/20 mL of the regular formula is equivalent to 625 mg/ 5 mL of the concentrated formula.

Usual Adult Dose for Abnormal Uterine Bleeding:

5 to 10 mg/day for 5 to 10 days

You should not use Megace ES if you are allergic to megestrol, or if you are pregnant.

To make sure Megace ES is safe for you, tell your doctor if you have ever had:

• diabetes;

• an adrenal gland disorder; or

• a stroke or blood clot.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Megace ES if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor if you become pregnant.

In animal studies, megestrol caused low birth weight and other problems when used during pregnancy. However, it is not known whether these effects would occur in humans. Ask your doctor about your risk.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Megace ES: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these side effects during or after your treatment with Megace ES:

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• swelling, warmth, or redness in an arm or leg;

• increased thirst, increased urination, dry mouth, fruity breath odor;

• weight gain (especially in your waist and upper back);

• muscle weakness, tiredness, feeling light-headed;

• skin discoloration, thinning skin, increased body hair; or

• mood changes, menstrual changes, sexual changes.

Common Megace ES side effects may include:

• nausea, gas, diarrhea;

• increased blood pressure;

• impotence, sexual problems;

• rash; or

• weakness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• a blood thinner - warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect megestrol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.