Pronunciation:

me-JES-trol AS-e-tate

Brand Names:

• Megace
• Megace ES
• Megace Os

Dosage Forms:

• Tablet
• Suspension

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Megestrol

Uses of This Medicine:

Megestrol tablet is used to treat advanced cancer of the breast or uterus in patients whose cancer has already spread, come back, or cannot be treated with surgery. Megestrol oral liquid is also used to treat anorexia, cachexia, or unexplained weight loss in patients with acquired immunodeficiency syndrome (AIDS).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of megestrol in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of megestrol in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal problems (eg, Cushing's syndrome) or
• Blood clots, history of or
• Diabetes—Use with caution. May make these conditions worse.

• Cancer or
• Endocrine disease or
• Infection or
• Kidney disease or
• Mental problems or
• Stomach or bowel problems—Megestrol oral liquid is not indicated to prevent weight loss in these patients.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

For cancer treatment, you may need to take the tablets for at least 2 months before it starts to work.

Measure the oral liquid medicine with a marked measuring spoon. Shake well before using.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For breast cancer:
    • Adults—40 milligrams (mg) 4 times a day for at least 2 months.
    • Children—Use and dose must be determined by your doctor.
  • For uterine cancer:
    • Adults—40 milligrams (mg) to 320 mg taken in divided doses per day for at least 2 months.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (suspension):
  • For treatment of anorexia, cachexia, or unexplained weight loss in patients with AIDS:
    • Adults—625 milligrams (mg) (5 milliliters [mL] or 1 teaspoon) per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using megestrol oral liquid while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may cause diabetes. Check with your doctor right away if you have blurred vision, dry mouth, flushed, dry skin, fruit-like breath odor, increased hunger, increased thirst, increased urination, loss of consciousness, nausea, stomach pain, sweating, trouble breathing, unexplained weight loss. or vomiting.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

dizziness

dry mouth

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

nausea

nervousness

slow or fast heartbeat

stomach pain

sweating

trouble breathing

unexplained weight loss

unusual tiredness or weakness

vomiting

Less common

Black, tarry stools

bladder pain

bloody or cloudy urine

burning or stinging of the skin

burning, tingling, numbness or pain in the hands, arms, feet, or legs

chest pain or discomfort

cough or hoarseness

discouragement

fast, irregular, pounding, or racing heartbeat or pulse

feeling sad or empty

fever or chills

frequent urge to urinate

irritability

lack of appetite

loss of interest or pleasure

lower back or side pain

painful cold sores or blisters on the lips, nose, eyes, or genitals

painful or difficult urination

right upper abdominal or stomach pain and fullness

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stabbing pain

swelling

swelling of the breasts or breast soreness in both females and males

swelling of the feet or lower legs

swollen glands

trouble concentrating

trouble sleeping

tumor

unusual bleeding or bruising

Incidence not known

Anxiety

backache

changes in skin color

facial hair growth in females

fractures

hives, itching, rash

joint or muscle pain

loss of sexual desire or ability

menstrual irregularities

muscle wasting

pain, tenderness, or swelling of the foot or leg

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

decreased interest in sexual intercourse

excess air or gas in the stomach or intestine

heartburn

inability to have or keep an erection

indigestion

loss in sexual ability, desire, drive, or performance

stomach discomfort or upset

Less common

Abnormal thinking

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

confusion

change in vision

constipation

increased salivation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.