Androcur (cyproterone) Depo ampoules 300 mg. 3 ml. N3

Description

Ingredients

active ingredient: cyproterone;

1 ml of the drug contains 100 mg of cyproterone acetate in an oil solution;

1 ampoule (3 ml) of the drug contains 300 mg of cyproterone acetate in an oil solution;

excipients: benzyl benzoate, castor oil for injection.

Dosage form

Oily solution for injections.

Basic physico-chemical properties: transparent solution, free of particles.

Pharmacotherapeutic group

Hormones of the gonads and drugs used in the pathology of the genital area. Antiandrogens. ATC code G03H A01.

Pharmacodynamics

Cyproterone acetate has antiandrogenic, progestogenic and antigonadotropic effects, which have been confirmed in animal studies and with volunteers.

Antiandrogenic action

Cyproterone acetate competitively suppresses the effect of androgens on target organs. In humans, the following interrelated conditions have been described: inhibition of sexual desire, decreased activity of the sebaceous glands, effect on hair growth, delay in androgenic growth impulses in the prostate tissue, inhibition of premature pubertal development processes, as well as in bone tissue.

Gestagenic action.

Cyproterone acetate is a potent progestogen. According to the results of the Kaufman test, a total dose of 20-30 mg already leads to the transformation of the endometrium.

Antigonadotropic action

As a potent progestogen, cyproterone acetate has a depressant effect on the central nervous system. Due to this antigonadotropic action, there is no increase in the secretion of the reverse regulation of luteinizing hormone, although as a result of the antiandrogenic action of cyproterone acetate, androgens are displaced by the hypothalamic receptors, with which they have a negative feedback. Even more, the secretion of luteinizing and follicle-stimulating hormones is suppressed by the progestogenic action of cyproterone acetate. As a result, the level of testosterone and estrogen in the blood serum decreases. This antigonadotropic effect in men is weakened, since the inhibitory effect of androgens is reduced due to the antiandrogenic components of the active substance that affect the hypothalamus.

Indications

Androkur®-depot is intended for use exclusively by men.

Applicable:

• to reduce sexual desire for sexual deviations;
• for the palliative treatment of metastatic or locally advanced unresectable prostate cancer, if treatment with luteinizing releasing hormone (LRH) analogues or surgery is insufficient or contraindicated;
• initially to reduce hot flashes, which may be caused by an increase in serum testosterone levels at the beginning of treatment with LHR agonists.

Contraindications

When used as palliative therapy for advanced prostate cancer and initially to reduce hot flashes:

• liver disease;
• Dubin-Johnson syndrome, Rotor syndrome;
• history of liver tumors (only in the case when the tumor is not caused by metastases of prostate cancer);
• a history of meningioma; established malignant diseases or suspicion of their presence (with the exception of advanced prostate cancer);
• severe chronic depression;
• thromboembolic events in history;
• hypersensitivity to the active substance or to any of the components of the drug;
• children’s and adolescence until the end of puberty.

When used to reduce sexual desire for pathological abnormalities in the genital area in men:

• liver disease;
• Dubin-Johnson syndrome, Rotor syndrome;
• history of liver tumors;
• a history of meningioma;
• established malignant diseases or suspicion of their presence;
• severe chronic depression; thromboembolic conditions in history;
• severe forms of diabetes mellitus with vascular complications;
• sickle cell anemia;
• hypersensitivity to the active substance or to any of the components of the drug; childhood and adolescence until the end of puberty and children

Dosage and administration

Injections should be given very slowly. Androcur Depo (cyproterone) is intended for intramuscular injection only. Care must be taken to ensure that the substance that is administered does not enter the vessel.

To reduce sexual desire for pathological abnormalities in the genital area in men. Deviations in sexual behavior require treatment only in case of significant severity of the symptoms of this disease. A prerequisite for treatment is the desire of the patient to be treated.

The content of one ampoule of Androcur Depo (cyproterone) (3 ml) is administered every 10-14 days as a deep intramuscular injection. In exceptional cases, if the effect of the treatment is insufficient, you can enter 2 ampoules every 10-14 days, preferably 3 ml (the contents of one ampoule) into the right and left gluteal muscle (M. glutaeus maximus).

To stabilize the therapeutic effect, it is necessary to use Androkur® Depot for a long time and, if possible, with psychotherapeutic measures.

After achieving a satisfactory therapeutic result, it is advisable to reduce the dose by gradually increasing the interval between injections. Dose reduction or discontinuation of the drug should occur gradually.

For the treatment of inoperable prostate cancer. The content of one ampoule of the drug (3 ml) is administered weekly as a deep intramuscular injection. With the improvement of the condition or remission of the disease, you should not change the prescribed dose of the drug or stop treatment.

Initially to reduce hot flashes. The content of one ampoule of Androcur Depo (cyproterone) (= 300 mg) is administered once as a deep intramuscular injection.