Cytadren (Oral)

Aminoglutethimide works on the adrenal cortex, which is a part of the body. It influences the production of steroids and has other effects as well. Aminoglutethimide is used to treat certain types of tumors that impact the adrenal cortex. It can also be used when the adrenal cortex is overactive but not cancerous.

Additionally, aminoglutethimide may be used to treat other specific conditions as decided by your doctor.

Aminoglutethimide is available only with a prescription from your doctor.

It is very important that your doctor check your progress at regular visits to make sure that Cytadren (Oral) 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 Cytadren (Oral).

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 Cytadren (Oral). 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. Cytadren (Oral) may weaken your body's defenses against infection or inflammation.

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

In deciding to use a medicine, the risks of taking it must be compared to the benefits it provides. This is a choice you and your doctor will make together. For this medicine, you should consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Aminoglutethimide has been tested in a small number of children. However, it was hard to determine the effects of aminoglutethimide in children because it was given along with other medicines.

Geriatric

Older adults are more likely to experience lack of energy and are generally more sensitive to the effects of aminoglutethimide.

Breast Feeding

There are no adequate studies on women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together despite possible interactions. In these cases, your doctor may adjust the dose, or other precautions may be needed. It is very important that your healthcare professional knows if you are taking any of the medicines listed below while using this medicine. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may increase the risk of certain side effects, but using both medicines may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both.

• Acenocoumarol
• Dexamethasone
• Digitoxin
• Theophylline
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Be sure to inform your doctor about any other medical issues, especially:

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

• Infection—May affect the adrenal cortex. If you are using a steroid supplement, your dose may need to be adjusted.

• Kidney disease or
• Liver disease—The effects of aminoglutethimide may be stronger due to slower removal from the body.

• Underactive thyroid—Aminoglutethimide can cause underactive thyroid.

Along with its beneficial effects, a medicine can also cause some unwanted effects. Some side effects are noticeable through signs or symptoms you can see or feel. Your doctor may check for other side effects through specific tests. Some unwanted effects that may occur with aminoglutethimide are listed below. Not all of these side effects will happen, but if they do, they may require medical attention.

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

Rare

• Black, tarry stools
• Blood in urine or stools
• Cough or hoarseness with fever or chills
• Fever or chills
• Lower back or side pain with fever or chills
• Painful or difficult urination with 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 you have any of the following side effects:

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 monitor:

More common

• Low red blood cell count
• Low white blood cell count

Some side effects might happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also provide ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have questions about them:

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 may also occur in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cytadren

Pharmacologic Class: Aromatase Inhibitor

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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.