In the U.S.—

In Canada—

• Antiadrenal
• Antineoplastic

Aminoglutethimide (a-mee-noe-gloo-TETH-i-mide ) acts on a part of the body called the adrenal cortex. It affects production of steroids and also has some other effects. Aminoglutethimide is used to treat some kinds of tumors that affect the adrenal cortex. Also, it is sometimes used when the adrenal cortex is overactive without being cancerous.

In addition, aminoglutethimide is sometimes used to treat certain other conditions as determined by your doctor.

Aminoglutethimide 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 aminoglutethimide, the following should be considered:

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

Pregnancy—Aminoglutethimide has been shown to cause birth defects in humans and animals. However, this medicine may be needed in serious diseases or in other situations that threaten the mother's life. In addition, aminoglutethimide has been shown to cause fertility problems in animals. Be sure you have discussed this with your doctor before taking this medicine.

Breast-feeding—It is not known whether aminoglutethimide passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—Aminoglutethimide has been tested in a limited number of children. However, the effects of aminoglutethimide in children were difficult to determine because it was given in combination with other medicines.

Older adults—Lack of energy is more likely to occur in the elderly, who are usually more sensitive to the effects of aminoglutethimide.

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

• Dexamethasone (e.g., Decadron)—Aminoglutethimide increases the rate at which dexamethasone is removed from the body

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Infection—May affect the adrenal cortex. If a steroid supplement is being used, a change in dose may be needed

• Kidney disease or
• Liver disease—Effects of aminoglutethimide may be increased because of slower removal from the body

• Underactive thyroid—Aminoglutethimide can cause underactive thyroid

Take this medicine 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.

This medicine sometimes causes nausea and vomiting. This effect usually goes away or lessens after you have taken the medicine for a while. It is very important that you continue to use this medicine even if you begin to feel ill. Ask your health care provider for ways to lessen these effects. Do not stop taking this medicine without first checking with your doctor.

If you vomit shortly after taking a dose of aminoglutethimide, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing—

The dose of aminoglutethimide 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, the patient's weight, and whether or not other medicines are also being taken. If you are taking aminoglutethimide at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of aminoglutethimide, ask your doctor.

Missed dose—

If you miss a dose of this medicine and remember within 2 to 4 hours of the missed dose, take it as soon as possible. Then go back to your regular dosing schedule. 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.

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 that the medicine is working properly and does not cause unwanted effects.

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

Before you have any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Because this medicine affects the adrenal gland, extra steroids may be needed.

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.

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.

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests. Some of the unwanted effects that may be caused by aminoglutethimide are listed below. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Rare
  • Black, tarry stools;  blood in urine or stools;  cough or hoarseness, accompanied by fever or chills;  fever or chills;  lower back or side pain, accompanied by fever or chills;  painful or difficult urination, accompanied by fever or chills;  pinpoint red spots on skin;  shortness of breath;  unusual bleeding or bruising;  yellow eyes or skin 
  
  

Check with your doctor as soon as possible if the following side effects occur:

• More common
  • Drowsiness;  measles-like skin rash or itching on face and/or palms of hands 
  
  

• Less common
  • Clumsiness;  dizziness or lightheadedness (especially when getting up from a lying or sitting position);  fast heartbeat;  mental depression;  shakiness;  slurred speech;  uncontrolled eye movements;  unusual tiredness or weakness 
  
  

• Rare
  • Neck tenderness or swelling 
  
  

This medicine may also cause the following side effects that your doctor will watch for:

• More common
  • Low red blood cell count;  low white blood cell count 
  
  

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
  • Loss of appetite;  nausea 
  
  

• Less common or rare
  • Deepening of voice in females;  headache ;  increased hair growth in females;  irregular menstrual periods;  muscle pain;  vomiting 
  
  

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, aminoglutethimide is used in certain patients with the following medical conditions:

• Breast cancer
• Prostate cancer

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.