Androcur-Depo solution 100mg/ml 3ml ampoules, 3pcs

Composition

Active ingredients:

ciproterone acetate 100 mg.

Auxiliary substances:

Benzyl benzoate – 618.6 mg,

castor oil-353.4 mg

Pharmacological action

Pharmacodynamics

Long-acting antiandrogenic drug. Competitively binds to tissue androgen receptors. Reduces or completely eliminates the effect of androgens on target organs (including the prostate gland). It has progestogenic activity and antigonadotropic properties.

When treated with Androcur Depot, there is a decrease in sexual desire and potency, as well as a decrease in gonadal function. These phenomena are reversible and disappear after discontinuation of the drug.

Pharmacokinetics

Suction and distribution

After intravenous use of Androcur Depot, ciproterone acetate is slowly and completely released. Cmax is reached in 2-3 days and is 180±54 ng / ml. After that, there is a decrease in the concentration of the drug in plasma with T_1/2 4±1.1 days. C_ss is achieved after approximately 5 weeks of Androcur Depot application.

Ciproterone acetate is almost completely bound to plasma proteins (albumin) (only 3.5-4% is in free form). Since the association with plasma proteins is non-specific, changes in the level of SHBG (sex hormone binding globulin) do not affect the pharmacokinetic parameters of ciproterone acetate.

Deduction

Most of the administered dose is excreted as metabolites in the urine and feces; a small amount is excreted unchanged in the bile.

Indications

• Correction of pathological deviations in the field of sexual behavior in men (if it is necessary to reduce sexual desire);
• inoperable prostate cancer.

Contraindications

• Liver diseases;
• hereditary benign hyperbilirubinemia (Dubin-Johnson syndrome, Rotor syndrome);
• liver tumors, including in the anamnesis (except for liver metastases of prostate cancer);
• cachexia (except for patients with prostate cancer);
• severe chronic depressive states;
• sickle cell anemia;
• hypersensitivity to the drug.

The question of whether Androcur Depot should be prescribed to patients with a history of prostate cancer with thromboembolic syndrome, as well as in the presence of severe diabetes with angiopathy, should be decided individually in each case, comparing the expected benefit of treatment and possible negative consequences.

Side effects

From the endocrine system: when used for several weeks, Androcur Depot suppresses spermatogenesis and exhibits antigonadotropic properties (after discontinuation of the drug, spermatogenesis is gradually restored over several months); sometimes-gynecomastia (in some patients-in combination with increased tactile sensitivity and soreness of the nipples), which gradually disappears after discontinuation of the drug; in some cases, a change in body weight is possible.

From the central nervous system: perhaps a feeling of fatigue, decreased activity; sometimes-anxiety, depression.

Interaction

When used concomitantly, Androcur Depot may alter the clinical efficacy of oral hypoglycemic drugs or insulin.

How to take, course of use and dosage

Androcur Depot is only introduced deep in/m.

To reduce sexual desire in men, the drug is administered every 10-14 days at a dose of 300 mg (1 ampoule). In exceptional cases, when this dose is insufficient,600 mg (2 ampoules) can be administered every 10-14 days (preferably 3 ml in the right and left buttocks). If a satisfactory treatment result is achieved, you should try to reduce the dose by gradually increasing the intervals between injections.

To stabilize the therapeutic effect, Androcur Depot injections should be continued for a long time and, if possible, with simultaneous psychotherapeutic treatment.

In case of inoperable prostate cancer, to exclude the action of androgens of the adrenal cortex, a drug of 300 mg is administered. If the condition improves or remission is achieved, treatment should not be interrupted or the dose should be reduced.

In rare cases, a short-term reaction may occur during the injection or immediately after it (urge to cough, coughing attacks, feeling of lack of air). Very slow use of the drug allows you to avoid such reactions.

Overdose

The development of pathological effects in case of accidental overdose is unlikely.

Treatment: if necessary, conduct symptomatic therapy.

Special instructions

The drug is not intended for use in women.

Prior to puberty, the use of Androcur Depot is undesirable, since it is impossible to exclude the adverse effect of the drug on the patient’s growth and his not yet stabilized endocrine system.

When using ciproterone acetate in a dose of 200-300 mg, a direct hepatotoxic effect (development of jaundice, liver failure) was described, which in several cases led to a fatal outcome. Most of the described observations relate to patients with prostate cancer. Toxic effects are dose-dependent and usually develop only after a few months of treatment. Liver function should be investigated before starting treatment, as well as if the development of hepatotoxic effects is suspected. If toxic liver damage is confirmed, the use of ciproterone acetate should be discontinued, except in cases where hepatotoxicity is due to other causes, such as liver metastasis. In this case, continuation of treatment is possible only in cases where the expected benefit of treatment exceeds the risk.

In rare cases, the development of liver tumors was observed against the background of the use of sex steroids. If severe abdominal pain, enlarged liver, or signs of intra-abdominal bleeding occur, this should be taken into account when making a differential diagnosis.

Patients with diabetes mellitus are treated under constant medical supervision.

When using ciproterone acetate in high doses, in rare cases, a feeling of lack of air may appear. In such cases, when making a differential diagnosis, it is necessary to take into account that progesterone and synthetic progestins have a stimulating effect on breathing. At the same time, hypocapnia develops and concomitant compensatory metabolic alkalosis, which does not require treatment.

There are isolated reports of the occurrence of thromboembolic processes during treatment with Androcur Depot. However, the causal relationship with taking the drug is questionable.

With the simultaneous use of alcohol that has a disinhibiting effect, patients with pathologically increased sexual desire may experience a decrease in the effect of Androcur Depot therapy.

Monitoring of laboratory parameters

Before starting therapy and during treatment, careful monitoring of liver function, adrenal cortex and peripheral blood picture is necessary.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Patients who engage in potentially dangerous activities that require increased attention should take into account that Androcur Depot can cause fatigue, decreased activity, and impaired ability to concentrate.

Form of production

Solution for intravenous use of oil

Storage conditions

Keep out of reach of children.

Shelf

life is 5 years.

Active ingredient

Ciproterone

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Description

For adults as prescribed by a doctor, For men

Indications

Cancer