Mitotane

Generic name: Mitotane
Brand names: Lysodren
Dosage form: oral tablet (500 mg)
Drug class: Miscellaneous antineoplastics

Usage of Mitotane

Mitotane is used to treat cancer of the adrenal gland (adrenal cortical carcinoma).

Mitotane may also be used for purposes not listed in this medication guide.

Mitotane side effects

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

Mitotane may cause serious side effects. Call your doctor at once if you have:

  • blurred or double vision;
  • confusion, problems with speech, balance, or walking;
  • a light-headed feeling, like you might pass out;
  • pelvic pain, vaginal bleeding;
  • easy bruising or bleeding (nosebleeds, bleeding gums); or
  • any bleeding that will not stop.
  • Common side effects of mitotane may include:

  • nausea, vomiting, loss of appetite;
  • diarrhea;
  • depressed mood;
  • dizziness, spinning sensation; or
  • rash.
  • 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.

    Before taking Mitotane

    Tell your doctor if you have ever had:

  • recent infection, surgery, or trauma;
  • liver disease; or
  • if you take a blood thinner (warfarin, Coumadin, Jantoven).
  • Do not use mitotane if you are pregnant. This medicine could harm the unborn baby or cause miscarriage or premature birth. Use effective birth control to prevent pregnancy while you are using mitotane.

    Do not breastfeed while using this medicine.

    Follow your doctor's instructions about how long to avoid pregnancy and breastfeeding after your treatment ends. Mitotane can stay in your bloodstream long after you stop using it.

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    How to use Mitotane

    Usual Adult Dose for Adrenal Cortical Carcinoma:

    2 to 6 g orally daily in 3 to 4 divided doses; increase dose incrementally to achieve a blood concentration of 14 to 20 mg/L, or as toleratedComments:-Initiate this drug in a hospital until a stable dosage regimen is achieved.-Data suggests continuous treatment with the maximum possible dosage is the best approach; patients who have been treated intermittently (i.e., therapy restarted when severe symptoms have reappeared) often do not respond after the third or fourth course.Use: For the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma

    Warnings

    You may need to take steroid medicine, or stop taking mitotane for a short time if you have a serious injury or medical emergency. Your doctor will determine when you can start taking mitotane again. Do not change your doses or medication schedule without advice from your doctor.

    You must remain under the care of a doctor while taking mitotane.

    What other drugs will affect Mitotane

    Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

    Other drugs may affect mitotane, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

    Disclaimer

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