Description
Latin name
CYPROTERONE-TEVA
Release form
Tablets.
Packaging
In a blister pack of 10 tablets. In a cardboard package 5 blisters.
Pharmacological action
Pharmacodynamics
Cyproterone acetate is a synthetic antiandrogenic drug. The mechanism of action is based on competitive binding to androgen receptors in androgen-dependent organs, which leads to a decrease in their functional activity. In addition to its antiandrogenic effect, cyproterone acetate also has strong antigonadotropic properties and progestational activity.
Pharmacokinetics
The drug is completely absorbed after oral administration, undergoing biotransformation in the liver. Cmax of the drug is reached on average after 3 hours. The half-life is 43.9 ± 12.8 hours. The drug is excreted mainly in the form of metabolites with bile and urine, part of the drug is excreted unchanged. The ratio of the drug in urine and bile is 3: 7. Binding to serum proteins is about 96%.
Indications
For men: metastatic or inoperable prostate cancer (without and after orchiectomy, as well as in combination with luteinizing hormone agonists – releasing hormone)
correction of pathological abnormalities in the field of sexual behavior (if necessary, reduce sexual activity).
In women: pronounced effects of androgenization, including various forms of hirsutism and acne
androgenetic alopecia.
Contraindications
Hypersensitivity to cyproterone or other components of the
preparation pregnancy and lactation period
severe liver dysfunction
Dubin-Johnson syndrome and Rotor syndrome
hepatic impairment, including prostate)
severe diabetes mellitus with vascular complications
cachexia (excluding patients with prostate cancer)
sickle cell anemia
thromboembol cal processes (including in the anamnesis)
severe chronic depression
idiopathic jaundice, cold sores or itching during previous pregnancies
adolescence to puberty.
Use during pregnancy and lactation
It is contraindicated to use the drug during pregnancy and lactation.
Composition
1 tablet contains:
Active ingredient: cyproterone acetate 50 mg.
Excipients: potato starch, lactose monohydrate, crospovidone, sodium lauryl sulfate, hydroxypropyl cellulose, talc, magnesium stearate, colloidal silicon dioxide.
Dosage and administration of
For the treatment of prostate cancer, Ciproteron-Teva is prescribed in a dose of 200-300 mg per day divided into 2-3 doses, long before signs of disease progression appear.
To reduce sexual activity: 100-200 mg per day (1-2 tablets twice a day), usually for several weeks until a therapeutic effect is achieved. Next, they switch to maintenance doses – 50 mg (half a tablet 2 times a day). Upon termination of treatment, the drug should be discontinued gradually (25 mg per week).
In women of childbearing age, Ciproteron-Teva is used in a dose of 100 mg once a day, starting from the first day of the menstrual cycle, for 10 days with the simultaneous administration of oral contraceptives. The next 10-day course of treatment begins strictly after 4 weeks. With the onset of the therapeutic effect, the dose of the drug can be reduced to 25-50 mg per day.
In postmenopausal women, Ciproperon-Teva is used at a dose of 25-50 mg per day for 21 days, followed by a week-long break, patients with a removed uterus can be prescribed in the same doses without a break.
Cyproterone-Teva tablets should be taken after meals with plenty of water (up to 100 ml).
Side effects
At the beginning of treatment, abdominal pain, nausea, increased fatigue, muscle weakness, dry skin, general apathy, depressive states or anxiety. May increase or decrease body weight. In individual cases, when using high doses, shortness of breath and impaired liver function were observed.
In men, gynecomastia and suppression of spermatogenesis are possible, in women – pain, tension or enlargement of the mammary glands, decreased libido, menstrual irregularities, cyclic bleeding may occur in postmenopausal women.
Drug Interaction
Co-administration of cyproterone with oral contraceptives increases the risk of thromboembolism.
Alcohol reduces the effect of cyproterone.
Overdose
If overdosed, if the patient is conscious and without spontaneous vomiting, vomiting should be induced. It is necessary to apply symptomatic therapy with constant observation of the patient and vital functions.
Storage conditions
Store at a temperature of 15-25 ° C in a dry, protected from light and out of reach of children.
Expiration
5 years.
Deystvuyuschee substances
cyproterone
Conditions of supply of pharmacies
Prescription
dosage form
dosage form
tablets
Teva Pharmaceutical Enterprise Co., Ltd., Israel
