Testosteroni propionas solution for infection. 5% of amp. 1 ml No. 5

Pharmacological properties

Pharmacodynamics. Testosteroni propionas has specific androgenic effect: stimulates development and function of external genitals, a prostate, seed bubbles and also secondary sexual characteristics in men (voice, indumentum). participates in forming of the constitution of a body and sexual behavior at men, strengthens a libido and potency, stimulates a spermatogenesis. reduces development lg and fsg. testosterone is an antagonist of female sex hormones — estrogen, possesses antineoplastic action in tumors of a mammary gland at women. has anabolic effect which is shown by stimulation of synthesis of protein, reduction of an adiposity, a delay in an organism necessary for synthesis of protein of potassium, phosphorus, sulfur, strengthening of fixing of calcium in bones and increase in muscle bulk. at sufficient proteinaceous nutrition stimulates production of erythropoietin.

Pharmacokinetics. After in oil or p / to introduction it is slowly absorbed in the place of an injection. Testosterone circulating in blood gets into target organs where it is restored to 5-α-дигидротестостерона which interacts with receptors of a cellular membrane and gets into a cell kernel. Up to 98% of medicament in blood plasma contacts proteins, generally globulins. It is metabolized in a liver to low-active and inactive metabolites which are brought out of an organism with urine. About 6% of medicament are removed with a stake in not changed state.

Indication

Replacement therapy at primary and secondary hypogonadism, an eunuchoidism, impotence of endocrine genesis, a postkastratsionny syndrome, a men's climax, infertility owing to disturbance of a spermatogenesis, an oligospermatism, the osteoporosis caused by insufficiency of androgens, a breast cancer, climacteric disorders at women (in combination with estrogen), dysfunctional uterine bleedings at a hyperestrogenism, the mastopathies which are followed by the premenstrual painful tension of mammary glands, endometriosis, a hysteromyoma.

Use

to Men at an eunuchoidism, a congenital underdevelopment of gonads, removal in their surgical way or as a result of an injury and also in an acromegalia medicament is appointed in oil or p / to on 25–50 mg every other day or in 2 days. duration of a course of treatment depends on efficiency of therapy and the nature of a disease. after improvement of a clinical picture Testosteroni propionas is entered in maintenance doses on 5–10 mg daily or every other day.

In impotence of endocrine genesis and also at the men's climax which is followed by vascular and nervous breakdowns Testoteron propionate is appointed on 10 mg daily or on 25 mg 2–3 times a week for 1–2 months

For treatment in male infertility use medicament in a dose on 10 mg 2 times a week within 4–6 months or on 50 mg every other day within 10 days.

At a pathological men's climax medicament are appointed on 25 mg by 2 times a week within 2 months with a monthly break.

At initial stages of a prostatauxe is entered on 10 mg of 1 times in 2 days for 1–2 months

to Women aged 45 years in dysfunctional uterine bleedings are more senior appoint 10–25 mg every other day within 20–30 days before the termination of bleeding and emergence of atrophic cells in vaginal smears.

Contraindication

Individual intolerance of drug, a prostate cancer or a breast cancer at men, liver tumors now or in the anamnesis, heavy abnormal liver functions, a hypercalcemia, a hypercalcuria, not treated stagnant heart failure, an ischemic heart disease.

Side effects

from a reproductive system and mammary glands: a priapism, the increased sexual excitement, strengthening a libido and a frequent erection, a gynecomastia, mammary gland pain. at use in high doses for men the oppression of a spermatogenesis, an atrophy of testicles is possible. androgens can cause a prostate hyperplasia, growth of malignant tumors of a prostate in men. at women the phenomena of a masculinization (virilism) can be observed: coarsening of a voice, excess growth of hair in the face and a body, pastosity of the person, oppression of function of ovaries, disturbances of periods, an atrophy of mammary glands and fabrics of endometrium, the increased skin oiliness, a clitoris hypertrophy. virilescence can be irreversible even after testosterone phase-out.

from a respiratory system: respiratory disturbances, an apnoea in a dream.

from a musculoskeletal system: onychalgia, arthralgia, myotonia.

Gastrointestinal disturbances: diarrhea, nausea, gastrointestinal bleeding.

Gepatobiliarny disturbances: increase in level of aminotransferases, abnormal liver functions, jaundice, cholestatic hepatitis, at use in high doses throughout the long period was reported about cases of tumors of a liver.

from the system of blood and lymphatic system: isolated cases of a polycythemia, tendency to fibrinferments, increase in a hematocrit, oppression of blood-coagulation factors.

from skin and its derivatives: various skin reactions, including an acne, seborrhea, baldness, an itching.

Metabolic and alimentary disturbances: increase in body weight, hypercalcemia, glucose exchange disturbance, increase in the LDL level, decrease in the LPVP level.

Neurologic disturbances: dizziness, the increased sweating, a headache, nervousness, a depression.

General disorders and disturbance in the place of an injection: pain in the place of an injection, a hypodermic hematoma in the place of an injection; long treatment by Testosteroni propionas or its use in high doses can sometimes lead to increase in frequency of cases of a delay of liquid and hypostases; reactions of hypersensitivity, including in the form of fervescence, a fever and feeling of heat in all body.

Special instructions

As well as all oil solutions, Testosteroni propionas enter in oil. it is necessary to watch that substance which is entered did not get to a vessel carefully. at very slow administration of solution it is possible to avoid emergence of the short-term reactions which sometimes are noted in time or right after an injection of oil solution (desires to cough, fits of coughing, respiratory depression).

With care the patient with heart failure, AG, epilepsy, migraine, a renal failure.

with dysfunctions of heart, kidneys or a liver in the anamnesis the use of androgens can cause a complication in the form of hypostases with stagnant heart failure In patients or without it. It is necessary to be careful at use of medicament for patients with the states causing a delay of liquid and causing development of hypostases. With care to use medicament at patients with a porphyria.

during medicament treatment should control indicators of function of a liver and kidneys, a thyroid gland and glucose level in blood.

Before an initiation of treatment at men needs to exclude a prostate cancer as at medicament use the androgens increase risk of developing a hyperplasia of a prostate. With the preventive purpose it is recommended to perform regular examinations of a prostate.

At the patients accepting androgens during the long period besides laboratory measurements of concentration of testosterone, it is necessary to check the following laboratory indicators: hemoglobin level, a hematocrit (at first — each 3 months, then — once a year) and functional trials of a liver.

Due to the possible tendency to a thrombogenesis with care medicament to men after recently undergone operation or an injury.

Abuse of medicament or accustoming. Androgens cannot be applied to strengthening of development of muscles in healthy people and to increase in physical abilities.

Use during pregnancy or feeding by a breast. There are no sufficient data on use of medicament during pregnancy or feeding by a breast. Taking into account characteristic virilizuyushchy influence of medicament on a fruit its use is contraindicated during pregnancy or feeding by a breast. Use of medicament should be stopped when diagnosing pregnancy.

Children. Safety and efficiency of use for children were not studied therefore medicament is not recommended to be used in pediatric practice. Use of testosterone for children together with a masculinization can become the reason of the accelerated growth and ripening of a bone tissue and also premature closing of the region of growth of an epiphysis that as a result will lead to decrease in final growth.

Ability to influence speed of response at control of vehicles or work with other mechanisms. During administration of medicament it is necessary to abstain from control of vehicles and work with other mechanisms.

Interaction

At the combined use with the substances which are inductors of microsomal enzymes of a liver (barbiturates, rifampicin, carbamazepine, phenylbutazone, Phenytoinum), the effect of testosterone can be weakened. at a pronounced hypogonadism Testosteroni propionas can be combined with the medicaments stimulating function of a thyroid gland, estrogen.

is Strengthened by action of anabolic means, vitamins, drugs, calciferous, phosphorus, slows down cyclosporine elimination.

Androgens can enhance tolerance to glucose and reduce the need for insulin or for oral antidiabetic medicaments at persons with diabetes.

Androgens can influence metabolism of other medicines (growth of concentration of an oksifenbutazon in blood plasma was noted). Besides, it was reported that testosterone and its derivatives increase activity of oral anticoagulants that can demand correction of their dose. Irrespective of this fact it is always necessary to adhere to the restrictions concerning injections in oil, to patients with the acquired or inherited disorders of blood clotting.

Simultaneous use of Testosterone and AKTG or corticosteroids can increase risk of appearance of hypostases.

Barbiturates and alcohol reduce activity of testosterone.

Overdose

At use of medicament in the raised doses or for a long time the side effects described in appropriate section can develop. in this case medicament should be cancelled, and after disappearance of androgenzavisimy side effects to continue in lower doses. if necessary to carry out symptomatic treatment.

to the termination of periods.

Storage conditions

In original packing at a temperature not above 25 °C.