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Trilostane (Systemic)

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Trilostane (Systemic)


Trilostane (TRYE-loe-stane) is used in the treatment of Cushing's syndrome. It is normally used in short-term treatment until permanent therapy is possible.

In Cushing's syndrome, the adrenal gland overproduces steroids. Although steroids are important for various functions of the body, too much can cause problems. Trilostane reduces the amount of steroids produced by the adrenal gland.

This product was withdrawn from the U.S. market in April 1994.

Special Considerations

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 trilostane, the following should be considered:


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


Use of trilostane is not recommended during pregnancy. It has been shown to cause serious problems, including miscarriage, in humans. Trilostane has also been shown to cause birth defects in animals.


It is not known whether trilostane passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.


There is no specific information about the use of trilostane in children.

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 trilostane 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 trilostane, it is especially important that your health care professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems

The presence of other medical problems may affect the use of trilostane. Make sure you tell your doctor if you have any other medical problems, especially:

    • Infection or

    • Injury (recent serious)-Trilostane may weaken the body's normal defenses

    • Kidney disease

    • Liver disease


Take trilostane 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.


The dose of trilostane 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 trilostane. If your dose is different, do not change it unless your doctor tells you to do so.

    • For oral dosage form (capsules):

    o For Cushing's syndrome:

      Adults-To start, 30 milligrams (mg) four times a day. Your doctor may increase the dose every three to four days as needed. However, the dose is usually not more than 90 mg four times a day.

      Children-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.


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 that trilostane is working properly and does not cause unwanted effects.

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

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking trilostane .

Your doctor may want you to carry a medical identification card or wear a bracelet stating that you are taking this medicine.

Side Effects

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:


Darkening of skin; drowsiness or tiredness; loss of appetite; mental depression; skin rash; vomiting.

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:

More common

Diarrhea; stomach pain or cramps.

Less common

Aching muscles; belching or bloating; burning mouth or nose; dizziness or lightheadedness; fever; flushing; headache; increase in salivation; nausea; watery eyes.

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

October 16, 2000

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