Cyproterone acetate is a synthetic antiandrogennnym drug. The mechanism of action is based on the competitive binding to the androgen receptor in androgen-dependent organs, which leads to a reduction of their functional activity. In addition to the antiandrogenic action, cyproterone acetate has also antigonadotropnym strong progestational activity and properties.
The drug is completely absorbed after oral administration, the biotransformation in the liver exposed. C max of the drug is achieved on average after 3 hours. The half-life was 43.9 ± 12.8 hours. The drug derived mainly as metabolites in the bile and urine of the drug appears unchanged. The ratio of the drug in the urine and the bile is 3: 7. Binding of serum proteins is about 96%.
Teva Pharmaceutical Enterprise Co., Ltd., Israel
1 tablet contains:
Active ingredient: 50 mg cyproterone acetate.
Excipients: potato starch, lactose monohydrate, crospovidone, sodium lauryl sulfate, hydroxypropyl cellulose, talc, magnesium stearate, colloidal silicon dioxide.
The blister 10 tablets. The carton 5 blisters.
- unresectable or metastatic prostate cancer (without and after orchiectomy, as well as in combination with agonists of luteinizing hormone – releasing hormone);
- correction of abnormalities in sexual behavior (with the need to reduce sexual activity).
- androgenization expressed phenomena, including various forms of hirsutism and acne;
- androgenic alopecia.
- Increased sensitivity to cyproterone or to other components of the drug;
- Pregnancy and lactation;
- The expressed disturbances of liver function;
- Dubin-Johnson syndrome and Rotor syndrome;
- Pujol liver, including history (except liver metastases for prostate cancer);
- severe diabetes with vascular complications;
- cachexia (except for patients with prostate cancer);
- sickle-cell anemia;
- thromboembolic processes (including in the anamnesis);
- severe chronic depression;
- idiopathic jaundice, herpes or itching during a previous pregnancy;
- adolescence until the completion of puberty.
Early treatment may experience abdominal pain, nausea, fatigue, muscle weakness, dry skin, general apathy, depression or anxiety state. It may increase or decrease body weight. In individual cases, the use of high doses dyspnea were observed and liver function abnormalities.
Men may cause gynecomastia and suppression of spermatogenesis, women – pain, stress, or breast enlargement, reduced libido, irregular menstrual cycle, cyclical bleeding can occur in postmenopausal women.
How to accept, acceptance rate and dosage
For treatment of prostate cancer Cyproterone-Teva administered in a dose of 200-300 mg per day, divided into 2-3 doses, long before the appearance of signs of disease progression.
To reduce sexual activity: 100-200 mg a day (1-2 tablets twice a day), usually for a few weeks to achieve a therapeutic effect. Next, moving to support dose – 50 mg (2 tablets at half times a day). At the termination of drug treatment should be withdrawn gradually (at 25 mg per week).
In women of childbearing age cyproterone Teva is used at a dose of 100 mg 1 time per day, from the first day of the menstrual cycle for 10 days while taking oral contraceptives. The next 10-day course of treatment starts exactly 4 weeks. Upon the occurrence of the therapeutic effect of the dose can be reduced to 25-50 mg per day.
In postmenopausal women Tsiproperon-Teva is used at a dose of 25-50 mg per day for 21 days followed by one week apart, patients with drug hysterectomy may be administered at the same dose without interruption.
Tablets Cyproterone-Teva be taken after a meal, with plenty of water (100 mL).
Store at a temperature of 15-25 ° C in a dry place, protected from light and the reach of children.
With simultaneous use of cyproterone with oral contraceptives increases the risk of thromboembolism.
Alcohol reduces the effect of cyproterone.
Treatment cyproterone Teva should be under the control of liver function, adrenal cortex and peripheral blood picture, blood glucose levels.
Where there is evidence of hepatotoxicity receiving the drug should be discontinued.
In persons suffering from alcoholism, the use of cyproterone usually ineffective. Patients with organic brain disorders and psychiatric illnesses, suffer from sexual disorders, usually resistant to treatment cyproterone Teva.
If the patient has impaired fertility, we recommend that you carry out the treatment spermiogram analysis.
Before treatment, women should conduct endocrinological tests and consult a gynecologist.
Patients suffering from mild forms of diabetes, glucose monitoring should be done more often than usual (for example, every 8 weeks).
Epilepsy, multiple sclerosis, porphyria, otosclerosis, tetanus, hypertension risk of adverse reactions increases.
At the beginning of treatment cyproterone Teva pregnancy should be completely excluded. women of childbearing age, along with oral contraceptives is recommended to use barrier contraceptives. If in the course of the treatment is stopped menstruation, the drug should be discontinued until the final elimination of pregnancy.
The negative impact of cyproterone Teva fertility after discontinuation of treatment were observed.
Effects on ability to drive vehicles and other machines that require high concentration of attention
In the period of treatment should refrain from activities that require attention.
Pregnancy and lactation
use the drug is contraindicated during pregnancy and lactation.
In case of overdose, if the patient is conscious and without spontaneous vomiting, induce vomiting. It is necessary to apply symptomatic therapy with continuous monitoring of patients, and vital functions.