Cyproteron acetate

Therapeutic Area:
Generic Name:

Cyproteron acetate

Dosage Form:

50 mg film coated tablet

Drug Dose

Therapeutic Indications:

It helps relieve the symptoms of a tumour of the prostate gland.

It can also be taken by males to control an over active sex drive.

Mechanism of Action:

Anti-androgen

Method of Administration:

For the control of an overactive sex drive the usual dose is 50 mg twice a day.

To help relieve the symptoms of a prostate cancer the usual doses are as follows:

  • to reduce the possible worsening of a prostate cancer, which can happen during the first few weeks of starting other treatments for prostate cancer, the usual daily dose is two 50 mg tablets twice daily (200 mg) alone for 5-7 days, followed by two 50 mg tablets twice daily (200 mg) for 3-4 weeks together with another medicine.
  • in long term treatment where other treatments or surgery are unsuitable, the usual daily dose is 200 mg to 300 mg (one 100 mg tablet or two 50 mg tablets twice or three times a day).
  • to treat hot flushes caused by other treatments for prostate cancer or following surgical removal of the testicles, the usual daily dose is 50 mg to 150 mg (one 50 mg tablet once or three times a day). Cyproterone Tablets are not recommended for use in male children and adolescents below 18 years of age.

Notes

Contraindications:

Do not take Cyproteron Tablets if you:

  • are allergic (hypersensitive) to cyproterone acetate, or any of the other ingredients in Cyproteron Tablets
  • are under 18 years of age
  • Have ever been diagnosed with a meningioma (a generally benign tumor of the tissue layer between the brain and the skull). You should ask your physician if you are in doubt.
  • have kidney failure
  • have liver disease (including Dubin-Johnson syndrome and Rotor syndrome) Malignant tumours (except for carcinoma of the prostate) Previous or existing liver tumours (only if these are not due to metastases from carcinoma of the prostate)

Interactions:

Thiazolidinediones, pioglitazone and rosiglitazone used in the treatment of diabetes, ketoconazole, itraconazole, clotrimazole used to treat fungal infections, rifampicine used to treat tuberculosis, phenytoin used to treat epilepsy, ritonavir used to treat HIV infection and AIDS, St Johns Wort (Hypericum perforatum), a herbal remedy, cholesterol-lowering drugs such as statins.

Pregnancy and Lactation:

Use is contraindicated in pregnancy and lactation

Warning and Precaution:

Before you take Cyproteron Tablets you should tell your doctor if you:

  • have liver disease
  • have a history of blood clots (heart attack, stroke, thrombosis or embolism)
  • suffer from diabetes
  • suffer from a condition called sickle cell anaemia (abnormalities of the red blood cells)
  • have or have ever suffered from depression
  • drink alcohol even if it is not regularly
  • are planning a family

Adverse Reactions:

Depressive moods and restlessness, increase or decrease in body weight which can be associated with fluid retention, shortness of breath, liver problems, some of them severe or even fatal have been reported with high-dosed cyproterone acetate treatment (200-300 mg daily), discomfort or enlargement of the breasts, hot flushes, sweating, tiredness

Storage:

Store below 30 and protect from light and moisture.