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|Mitotane

Mitotane

Mitotane is used for:

Treating adrenal cortical cancer that cannot be treated with surgery.

Mitotane is an adrenal cytotoxic agent. How Mitotane works is not fully understood. It is thought to slow adrenal gland function.

Do NOT use Mitotane if:

• you are allergic to any ingredient in Mitotane
• you have suffered severe trauma or shock

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mitotane :

Some medical conditions may interact with Mitotane . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver problems

Some MEDICINES MAY INTERACT with Mitotane . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because their effects may be decreased by Mitotane

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mitotane may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mitotane :

Use Mitotane as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Mitotane may be taken with or without food.
• Mitotane may be started in a hospital setting until an individualized dose is determined.
• If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.
• If you miss a dose of Mitotane , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Mitotane .

Important safety information:

• Mitotane may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Mitotane . Using Mitotane alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• LAB TESTS, such as adrenal function tests and neurological and behavioral tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Mitotane during pregnancy. It is unknown if Mitotane is excreted in breast milk. Do not breast-feed while taking Mitotane .

Possible side effects of Mitotane :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Depression; diarrhea; dizziness; drowsiness; feeling of a whirling motion; lack of energy; loss of appetite; nausea; skin rash; sleepiness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); brain damage; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Mitotane at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mitotane out of the reach of children and away from pets.

General information:

• If you have any questions about Mitotane , please talk with your doctor, pharmacist, or other health care provider.
• Mitotane is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Mitotane . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.