Megace

DRUG DESCRIPTION

MEGACE® (megestrol acetate, USP) Oral Suspension contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17?-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37° C in water is 2 µg per mL, solubility in plasma is 24 µg per mL. Its molecular weight is 384.51.

The empirical formula is C24H32O4 and the structural formula is represented as follows:

Megace®
  (megestrol acetate) Structural Formula Illustration

MEGACE (megestrol acetate) Oral Suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL.

MEGACE (megestrol acetate) Oral Suspension contains the following inactive ingredients: alcohol (max. 0.06% v/v from flavor), citric acid, lemon-lime flavor, polyethylene glycol, polysorbate 80, purified water, sodium benzoate, sodium citrate, sucrose and xanthan gum.

What are the possible side effects of megestrol (Megace)?

Stop taking megestrol and seek emergency medical attention or call your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • sudden severe headache;
  • changes in vision; or
  • numbness or swelling in an arm or leg.

Other, less serious side effects may be more likely to occur. Notify your doctor if you experience

  • nausea or...

Read All Potential Side Effects and See Pictures of Megace »

What are the precautions when taking megestrol acetate (Megace)?

Before taking megestrol, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems (e.g., Cushing's syndrome), blood clots, congestive heart failure, diabetes, high blood pressure, kidney problems, unusual vaginal bleeding.

High blood sugar (hyperglycemia) and worsening of diabetes may occur. Symptoms of high blood sugar include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor...

Read All Potential Precautions of Megace »


Megace Consumer (continued)

SIDE EFFECTS: This medication can cause weight gain, changes in appetite, stomach upset, diarrhea, gas, trouble sleeping, decreased sexual ability/desire, or fever. Women may experience changes in their menstrual periods, including unpredictable bleeding. If any of these effects persist or worsen, inform your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: fast/pounding heartbeat, headache, swelling of hands/feet, fatigue.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, confusion, mental/mood changes, weakness/numbness on one side of the body, pain/redness/swelling of arms or legs, slurred speech, trouble breathing, severe or sudden vision changes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking megestrol, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems (e.g., Cushing's syndrome), blood clots, congestive heart failure, diabetes, high blood pressure, kidney problems, unusual vaginal bleeding.

High blood sugar (hyperglycemia) and worsening of diabetes may occur. Symptoms of high blood sugar include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. People with diabetes should monitor their blood sugar levels more frequently when they start taking this medication and whenever the dose changes since they may need to change their doses of diabetic medications.

This drug may decrease adrenal gland activity. Make sure you tell your doctors and dentists of your megestrol use and when you stopped using it. After stopping this drug, additional corticosteroids (e.g., prednisone or hydrocortisone) may be necessary in stressful situations such as trauma, major surgery or serious infection. Consult your doctor or pharmacist for details. Symptoms of adrenal problems include unusual weakness, dizziness, nausea and rapid weight loss.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug and to its side effects.

This medication must not be used during pregnancy. Megestrol may cause harm to your unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Women of childbearing age should use an effective form of birth control while using this medication. Consult your doctor for more details.

Megestrol may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Megace Patient Information Including Side Effects

Brand Names: Megace

Generic Name: megestrol (Pronunciation: meh JESS trol)

  • What is megestrol (Megace)?
  • What are the possible side effects of megestrol (Megace)?
  • What is the most important information I should know about megestrol (Megace)?
  • What should I discuss with my healthcare provider before taking megestrol (Megace)?
  • How should I take megestrol (Megace)?
  • What happens if I miss a dose (Megace)?
  • What happens if I overdose (Megace)?
  • What should I avoid while taking megestrol (Megace)?
  • What other drugs will affect megestrol (Megace)?
  • Where can I get more information?

What is megestrol (Megace)?

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

Megestrol is used to treat loss of appetite and weight loss because of disease. Megestrol is also used in the treatment of advanced breast cancer and endometrial cancer.

Megestrol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of megestrol (Megace)?

Stop taking megestrol and seek emergency medical attention or call your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • sudden severe headache;
  • changes in vision; or
  • numbness or swelling in an arm or leg.

Other, less serious side effects may be more likely to occur. Notify your doctor if you experience

  • nausea or vomiting,
  • dizziness,
  • mild shortness of breath;
  • weakness,
  • headache,
  • menstrual bleeding,
  • hot flashes or sweating,
  • decreased sex drive, or
  • insomnia.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about megestrol (Megace)?

Notify your doctor if you develop any side effects while taking megestrol.

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