Megace (Oral)

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

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

It is very important that your doctor checks your progress at regular visits to ensure 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 problems with your adrenal glands. 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.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medications. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies to show how megestrol affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies so far have not found specific problems in elderly patients that would limit the use of megestrol. However, older patients may have age-related liver, kidney, or heart issues, which may need careful monitoring and possible dose adjustments.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other situations, two different medicines may be used together, even if there could be an interaction. If you are taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

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

• Dofetilide

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If you are prescribed both, your doctor may adjust the dose or frequency for one or both medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to inform your doctor about any other medical problems, especially:

• Adrenal problems (e.g., Cushing's syndrome) or
• History of blood clots or
• Diabetes—use with caution, as it may worsen this condition.

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

Along with its beneficial effects, Megace (Oral) may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Megace (Oral). Your health care professional may also provide ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Megace
• Megace ES

In Canada

• Megace Os

Available Dosage Forms:

• Tablet
• Suspension

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Megestrol

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.