Cyproterone TEVA

Active material: Cyproterone
When ATH: G03HA01
CCF: Antiandrogen drug
When CSF: 15.13.03.01
Manufacturer: TEVA Pharmaceutical Industries Ltd. (Israel)

Pharmaceutical form, composition and packaging

Pills white, round, с риской на одной стороне и надписью “CYPROT 50” – на другой.

Excipients: potato starch, lactose monohydrate, krospovydon, sodium lauryl, hydroksypropyltsellyuloza, talc, magnesium stearate, colloidal silicon dioxide.

10 PC. – блистеры (5) – пачки картонные.

Pharmacological properties

Farmakodinamika

Cyproterone acetate is a synthetic drug antiandrogennnym. 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 also has a strong antigonadotropnym properties and progestin activity.

Pharmacokinetics

The drug is completely absorbed after oral administration, undergoing hepatic biotransformation. The maximum drug concentration in serum is achieved at a mean 3 o'clock. The half-life of 43,9 +_12,8 Hours. The drug is derived mainly as metabolites in the bile and urine, of the drug is excreted unchanged in. The ratio of the drug in the urine and bile of 3:7. Binding to plasma proteins is approximately 96%.

INDICATIONS FOR USE

У мужчин – метастазирующий или неоперабельный рак предстательной железы (without and after orchiectomy, as well as in combination with agonists of LH hormone -rilizing), correction of abnormalities in sexual behavior (if necessary, reduce sexual activity).

У женщин – выраженные явления гидрогенизации, including various forms of acne and hirsutism, androgennaya alopecia.

DOSAGE AND ADMINISTRATION

For the treatment of prostate cancer cyproterone Teva administered in a dose 200-300 mg per day divided into 2-3 admission, long before signs of disease progression.

To reduce sexual activity cyproterone Teva administered in a dose 100-200 mg per day (by 1-2 tablets twice a day) normally within a few weeks to achieve a therapeutic effect. Далее переходят на поддерживающие дозы – 50мг (for half tablets 2 once a day). Upon termination of drug treatment should be withdrawn gradually (on 25 mg per week).

In women of childbearing age cyproterone Teva is used at a dose of 100 mg 1 once a day from the first day of the menstrual cycle for 10 days while taking oral contraceptives. The next 10-day course of treatment begin strictly through 4 of the week. When the therapeutic effect dose can be reduced to 25-50 mg per day.

In postmenopausal women, cyproterone Teva is used at a dose of 25-50 mg daily for 21 day, followed by one week apart, hysterectomy patients with the drug may be administered at the same dose without interruption.

Cyproterone tablets Teva should be taken after a meal, drinking plenty of water (to 100 ml)

Side effect

At the beginning of the treatment can be observed abdominal pain, nausea, fatigue, muscular weakness, xerosis, general apathy, depression or anxiety state. May increase or decrease body weight. In individual cases, the use of high doses observed dyspnea and abnormal liver function. Men may cause gynecomastia and suppression of spermatogenesis, -More women, voltage or breast enlargement, decreased libido, menstrual irregularities, in postmenopausal women may experience cyclical bleeding.

Contraindications

• Hypersensitivity to cyproterone or other components of the drug.
• Pregnancy and lactation
• Expressions of the liver
• Dubin-Johnson syndrome and Rotor
• Liver tumors, including a history (with the exception of liver metastases in prostate cancer)
• Severe diabetes with vascular complications
• Kaxeksija (except in patients with prostate cancer)
• Drepanocytemia
• Thromboembolic processes (including a history)
• Severe chronic depression
• Idiopathic jaundice, herpes or itching during a previous pregnancy Adolescence until completion of puberty.

Interaction with other drugs

In an application with oral contraceptives cyproterone increased risk of thromboembolism. Alcohol reduces the effect of cyproterone.

Overdose

In case of overdose, If the patient is conscious and without spontaneous vomiting, , induce vomiting. Symptomatic therapy should be used with constant monitoring of patients, and vital functions.

Cautions

Treatment cyproterone Teva should be under the control of liver function, adrenal cortex and peripheral blood, Blood Glucose. Where there is evidence of hepatotoxicity taking the drug should be discontinued. Individuals, alcoholics, the use of cyproterone usually ineffective. Patients with organic brain disorders and psychiatric illnesses, suffering from sexual disorders, usually resistant to treatment cyproterone-Teva.

If the patient has impaired fertility, It recommended before starting treatment to analyze spermiogram.

Before treatment, women should conduct endocrinological tests and consult a gynecologist

Patients, suffering from mild forms of diabetes, monitoring glucose levels should be conducted more frequently, than usual (eg, every 8 weeks). In epilepsy, množestvennom sclerosis, porfirii, otosclerosis, stolbnyake, hypertension risk of adverse reactions increases. At the beginning of treatment cyproterone Teva pregnancy should be completely excluded. Women of childbearing age, together with oral contraceptives is recommended to use barrier contraceptives. If in the course of 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.

During the period of treatment should refrain from activities, requiring attention.

STORAGE CONDITIONS

Хранить при температуре +15°С – +25°С, in a dry dark place.

KEEP OUT OF THE REACH OF CHILDREN!

Shelf life 5 years

Do not use after the expiry date, on the package

Conditions of supply of pharmacies

Sold by prescription.