Expiration date: 02/2025
Clinical pharmacology
Pharmacodynamics
Ciproteron acetate is a synthetic anti-androgen 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 the antiandrogenic action, cyproteron acetate also has strong antigonadotropic properties and gestagenic activity.
Pharmacokinetics
The drug is completely absorbed after ingestion, undergoing biotransformation in the liver. Smahpreparata achieved an average of 3 no. the half-life of 43.9 ± 12.8 no. the Drug is excreted mainly in the form of metabolites of bile and urine, part of the drug is excreted unchanged. The ratio of the drug in the urine and bile is 3: 7. Binding to serum proteins is about 96%.
Form of issue and composition
Tablets
1 tablet contains:
Active substance:cyproterone acetate 50 mg.
Excipients: potato starch, lactose monohydrate, crospovidone, sodium lauryl sulfate, hydroxypropyl cellulose, talc, magnesium stearate, silicon dioxide colloidal.
In blister packs of 10 tablets. In cardboard packaging 5 blisters.
Special instruction
Treatment with Ciproteron-Teva should be carried out under the control of liver function, adrenal cortex and peripheral blood picture, blood glucose.
If there are signs of hepatotoxicity, the drug should be discontinued.
In persons suffering from alcoholism, the use of ciproteron is usually ineffective. Patients with organic disorders of the brain and mental diseases, suffering from sexual disorders, usually resistant to treatment with Ciproteron-Teva.
If the patient has impairment of fertility before any treatment to analyze spermatogramma.
Before starting treatment, women need to conduct endocrinological tests and get advice from a gynecologist.
In patients with mild diabetes, monitoring of sugar levels should be carried out more often than usual (for example, every 8 weeks).
With epilepsy, multiple sclerosis, porphyria, otosclerosis, tetanus, hypertension, the risk of adverse reactions increases.
At the beginning of treatment with Ciproteron, pregnancy should be completely excluded. Women of childbearing age are recommended to use barrier contraceptives along with oral contraceptives. If in the course of treatment menstruation stops, the drug should be discontinued until the final exclusion of pregnancy.
There was no negative effect of Ciproteron-TeV on fertility after discontinuation of treatment.
Influence on the ability to drive vehicles and other mechanisms that require increased concentration
During treatment, it is necessary to refrain from activities that require increased attention.
Interaction
While the use of ciproteron with oral contraceptives increases the risk of thromboembolism.
Alcohol reduces the effect of cyproterone.
Overdose
In case of overdose, if the patient is conscious and without spontaneous vomiting, vomiting should be caused. It is necessary to apply symptomatic therapy with constant monitoring of the patient and vital functions.
