Description
Latin name
ANDROCURВ® DEPOT
Release form
Intramuscular solution oil delivery
Packing
3 ampoules of 3 ml.
Pharmacological action
Androkur – antiandrogenic, progestational.
Pharmacodynamics
Long-acting antiandrogenic drug. Competitively binds to androgen tissue receptors. Reduces or completely eliminates the effect of androgens on target organs (including the prostate gland). It has gestagenic activity and antigonadotropic properties.
During treatment with Androkur 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
Absorption and distribution of
After i / m administration of Androkur Depot cyproterone acetate is slowly and completely released. Cmax is reached after 2-3 days and is 180 ± 54 ng / ml. After this, there is a decrease in the concentration of the drug in plasma from T1 / 2 4 ± 1.1 days. Css is achieved after about 5 weeks of using Androkur Depot.
Cyproterone acetate is almost completely bound to plasma proteins (albumin) (only 3.5-4% is in free form). Since the connection with plasma proteins is nonspecific, changes in the level of SHBG (sex hormone binding globulin) do not affect the pharmacokinetic parameters of cyproterone acetate.
Excretion
Most of the administered dose is excreted in the form of metabolites with urine and feces, a small amount – unchanged with bile.
Indications
Increased sex drive for sexual deviations antiandrogen therapy for inoperable carcinoma of the prostate gland.
Contraindications
hypersensitivity to cyproterone or other components of the drug
liver disease (including Dubin-Johnson syndrome, Rotor syndrome)
liver tumors in history or currently (with the exception of metastases of prostate cancer in liver srd) (with the exception of cachexia in prostate cancer)
severe chronic depression
thrombosis and thromboembolism currently
the presence of meningiomas currently or in the history of
children and adolescents under 18 years of age.
Caution: if patients with an inoperable prostate cancer have thrombosis and thromboembolism with a history of severe diabetes mellitus with angiopathy, Sickle cell anemia Androkur® is prescribed only after assessing the individual ratio of benefit and risk in each case.
Use during pregnancy and lactation
The drug is not intended for use in women.
Composition of
1 ml of solution contains:
Active substances: cyproterone acetate 100 mg
Excipients: benzyl benzoate – 618.6 mg, castor oil – 353.4 mg.
Dosage and administration of
Androkur Depot is administered only deeply in oil.
To reduce sexual desire in men, a drug of 300 mg (1 ampoule) is administered every 10-14 days. In exceptional cases, when this dose is not enough, you can enter 600 mg (2 ampoules) every 10-14 days (preferably 3 ml in the right and left buttocks). When a satisfactory treatment result is achieved, one should try to reduce the dose, gradually increasing the intervals between injections.
In order to stabilize the therapeutic effect, Androkur Depot injections should be continued for a long time and, if possible, with simultaneous psychotherapeutic treatment.
With inoperable prostate cancer, 300 mg is administered to exclude the action of androgens in the adrenal cortex. In case of improvement or achievement of remission, treatment should not be interrupted or the dose should be reduced.
In rare cases, a short-term reaction may occur during or immediately after an injection (coughing, coughing, feeling short of air). Very slow administration of the drug avoids such reactions.
Side effects
From the hematopoietic system: frequency unknown – anemia.
On the part of the immune system: rarely – hypersensitivity reactions.
Mental disorders: often – depression, depressed mood, feeling of anxiety (temporarily).
From the vascular side: the frequency is unknown – thrombosis and thromboembolism, oil microembolism of the pulmonary artery, vasovagal reactions.
From the side of the respiratory system: often – shortness of breath.
From the gastrointestinal tract: frequency unknown – intraperitoneal bleeding.
From the liver and biliary tract: often – jaundice, hepatitis, liver failure *.
From the skin and subcutaneous tissues: infrequently – rash.
From the musculoskeletal system: the frequency is unknown – osteoporosis.
From the genitals and mammary glands: very often – reversible suppression of spermatogenesis, decreased libido, erectile dysfunction often – gynecomastia.
Other: often – increase or decrease in body weight, increased fatigue, hot flashes, increased sweating very rarely – development of benign or malignant liver tumors, frequency is unknown – development of meningioma
Drug Interaction
When co-administered with Androcur Depot, it may alter the clinical efficacy of oral hypoglycemic agents or insulin.
Overdose
Development of pathological effects in case of accidental overdose is unlikely.
Treatment: Symptomatic therapy is carried out if necessary.
Storage conditions
Keep out of the reach of children.
Expiration
5 years.
Deystvuyuschee substances
cyproterone
Pharmacy terms
Prescription
dosage form
dosage form
injection
