In the U.S.—

In Canada—

• Antiadrenal
• Antineoplastic

Mitotane (MYE-toe-tane) is a medicine that acts on a part of the body called the adrenal cortex. It is used to treat some kinds of cancer that affect the adrenal cortex. Also, it is sometimes used when the adrenal cortex is overactive without being cancerous.

Mitotane reduces the amounts of adrenocorticoids (cortisone-like hormones) produced by the adrenal cortex. These steroids are important for various functions of the body, including growth. However, too much of these steroids can cause problems.

Mitotane is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S. and Canada)

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 mitotane, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to mitotane. Also tell your health care professional if you are allergic to any other substance, such as foods, preservatives, or dyes.

Pregnancy—Mitotane has not been shown to cause problems in humans.

Breast-feeding—Although it is not known whether mitotane passes into the breast milk, it has not been reported to cause problems in nursing babies.

Children—Although there is no specific information about the use of mitotane in children, it is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of mitotane in the elderly.

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 mitotane, it is especially important that your health care professional know if you are taking any of the following:

• Central nervous system (CNS) depressants—CNS depressant effects may be increased

• Infection

• Liver disease—Effects may be increased because of slower removal of mitotane from the body

Take mitotane only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered.

Do not stop taking this medicine without first checking with your doctor. To do so may increase the chance of unwanted effects.

Dosing—

The dose of mitotane will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for and whether or not other medicines are also being taken. If you are taking mitotane at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of mitotane, ask your doctor.

Missed dose—

If you miss a dose of this medicine, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and do not double the next one. Instead, go back to your regular dosing schedule and check with your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Your doctor may want you to carry an identification card stating that you are taking this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; tricyclic antidepressants (medicine for depression); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Check with your doctor right away if you get an injury, infection, or illness of any kind. This medicine may weaken your body's defenses against infection or inflammation.

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 as soon as possible if any of the following side effects occur:

• More common
  • Darkening of skin;  diarrhea;  dizziness;  drowsiness;  loss of appetite;  mental depression ;  nausea and vomiting;  skin rash;  unusual tiredness 
  
  

• Less common
  • Blood in urine;  blurred vision;  double vision 
  
  

• Rare
  • Shortness of breath;  wheezing 
  
  

Other 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. However, check with your health care professional if any of the following side effects continue or are bothersome:

• Less common
  • Aching muscles;  dizziness or lightheadedness when getting up from a lying or sitting position;  fever;  flushing or redness of skin;  muscle twitching 
  
  

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