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Cyproterone (Oral route, intramuscular route)

Pronunciation:

sye-PROE-ter-one

Dosage Forms:

  • Injectable
  • Tablet

Uses of This Medicine:

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.

This medicine 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.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Studies on this medicine 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.

Older adults—

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.

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

Other interactions—

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 this medicine. 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 This Medicine:

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 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.

  • 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 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.

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

Precautions While Using This Medicine:

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.

This medicine may cause some people to become drowsy, dizzy, 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.

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 this medicine:

  • 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.

Side Effects of This Medicine:

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.


Last Updated: 11/4/2014

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