cyproterone Oral, Intramuscular

sye-PROE-ter-one

Available Dosage Forms:

• Injectable


• Tablet

Uses For cyproterone

Cyproterone is used to treat cancer of the prostate gland. The prostate gland is present only in males; therefore, females do not get prostate cancer.

cyproterone blocks the effect of the male hormone testosterone in the body. This decreases the amount of testosterone produced in the body and is one way of treating this type of cancer.

cyproterone is available only with your doctor's prescription.

Before Using cyproterone

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 cyproterone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cyproterone or any other medicines. Also tell your health care professional if you have 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

Studies on cyproterone have been done only in adult patients, and there is no specific information comparing use of cyproterone in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically 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 comparing use of cyproterone in the elderly with use in other age groups.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Blood clots (or history of) or


• Circulation disease (or history of) or


• Stroke (or history of)—If these conditions already are already present, cyproterone may have a greater chance of causing blood clotting problems.

• Cardiac disease—May make the condition worse.

• Depressive tendencies—May cause depression to occur.

• Type 2 diabetes mellitus—May cause a loss of control of diabetes by increasing blood and urine sugar.

• Liver disease—Effects of cyproterone may be increased because of its slower removal from the body.

Proper Use of cyproterone

At first, cyproterone often causes loss of strength and energy or tiredness. However, these effects are lessened after about the third month of treatment and it is very important that you continue to receive this medication.

This medication should not be discontinued even if improvement of the disease occurs.

Dosing

The dose of cyproterone 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 cyproterone. 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.

• For oral dosage form (tablets):
  
  • For treating prostate cancer:
    
    • Adults—100 to 200 milligrams (mg) per day divided into 2 to 3 doses. Take after meals.
    
    
  
  

• For injection dosage form:
  
  • For treating prostate cancer:
    
    • Adult—300 milligrams (mg) injected into a muscle once a week.
    
    
  
  

Missed Dose

If you miss a dose of cyproterone, 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using cyproterone

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

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

Cyproterone may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking cyproterone:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat. Also, wear sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.


• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.


• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

While you are taking cyproterone, be careful to limit the amount of alcohol you drink.

cyproterone 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:

Less common

• Abdominal pain or tenderness


• agitation


• back pain


• black, tarry stools


• blisters on the skin


• bloody urine


• blurred vision


• chest pain


• chills


• clay-colored stools


• confusion


• cough


• dark urine


• decreased appetite


• decreased urine output


• difficulty swallowing


• dilated neck veins


• dizziness


• drowsiness


• dry mouth


• fainting or light-headedness when getting up from a lying or sitting position suddenly


• fast heartbeat


• fatigue


• fever


• flushed, dry skin


• fruit-like breath odor


• general feeling of discomfort or illness


• hallucinations


• headache, sudden and severe


• hives


• inability to speak


• increased blood pressure


• increased hunger


• increased thirst


• increased urination


• irregular breathing


• irregular heartbeat


• itching


• loss of consciousness


• lower back or side pain


• mood or mental changes


• nausea and vomiting


• painful or difficult urination


• pains in the chest, groin, or legs, especially the calves of legs


• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue


• red, thickened, or scaly skin


• seizures


• shortness of breath


• skin rash


• slurred speech


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• stiff neck


• stomachache


• sudden loss of coordination


• sweating


• swelling of the feet or lower legs


• swollen and/or painful glands


• temporary blindness


• tightness in the chest


• unexplained weight loss


• unusual bleeding or bruising


• vision changes


• weakness in the arm and/or leg on one side of the body, sudden and severe


• wheezing


• yellow eyes or skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Decreased interest in sexual intercourse


• inability to have or keep an erection


• increase in sexual ability, desire, drive, or performance


• increased interest in sexual intercourse


• loss in sexual ability, desire, drive, or performance


• swelling of the breasts or breast soreness in both females and males


• unexpected or excess milk flow from breasts

Less common

• Bleeding, blistering, burning, coldness, or discoloration of the skin


• change in walking and balance


• clumsiness or unsteadiness


• hair loss


• inability to move legs or arms


• increased sensitivity of skin to sunlight


• increase in bowel movements


• loose stools


• loss of strength or energy


• muscle pain or weakness


• paralysis of one side of the body


• redness or other discoloration of the skin


• severe sunburn


• soft stools


• tiredness or weakness


• unusual increase in hair growth


• weight gain

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

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

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