Instruction for use
international and chemical names: Testosterone; 3-oxoandrosta-4-EN-17B-yl propionate;
basic physical and chemical properties: oily liquid light yellow color.
composition: 1 ml contains testosterone propionate 50 mg;
excipients: olive oil.
Form of issue. Solution for injection oil.
Pharmacotherapeutic group. Androgens.
ATC code G0ЗВ AND 0S.
The pharmacological properties. Pharmacodynamics. Testosterone propionate shows well specific androgen action: stimulates the development and function of external genitalia, prostate, seminal vesicles, and secondary sexual characteristics in men (voice, hair). Involved in the formation of the Constitution of the body and sexual behavior in men, increases libido and potency, stimulates spermatogenesis. Reduces the secretion of luteotrophic and follicle-stimulating hormones. Testosterone is an antagonist of female hormones – estrogen, has an antitumor effect in breast tumors in women. Has anabolic effect which manifests itself in stimulating protein synthesis, reducing fat deposits, delayed in the body necessary for the synthesis of protein, potassium, phosphorus, sulfur, enhancing fixation of calcium in the bones and increasing muscle mass. With sufficient protein nutrition stimulates the secretion of erythropoietin.
Pharmacokinetics. After intramuscular or subcutaneous injection is slowly absorbed from the injection site. Testosterone circulating in the blood, gets into the target organs, where it is restored to 5-alpha-dihydrotestosterone which interacts with receptors on the cell membrane and enters the cell nucleus. Up to 98% of the drug in plasma is bound to proteins, mainly globulins. Metabolised in the liver to inactive and active metabolites that are excreted in the urine. Approximately 6% of the drug excreted by the intestine in an unchanged state.
Indications for use. Replacement therapy in primary and secondary gogogadget, evnuhoidizme; impotence endocrine Genesis, postgastric tion syndrome, male menopause; infertility as a result of violation of spermatogenesis oligospermia; osteoporosis caused by androgen deficiency, acromegaly; hormone-dependent tumors in women (breast cancer, ovarian), climacteric disorders in women (combined with estrogens); functional bleeding in berestovets; mastitis, accompanied by painful premenstrual tension of the mammary glands; endometriosis, uterine fibroids.
Method of application and doses. Men with evnuhoidizme, congenital underdevelopment gonads, removing them surgically or due to trauma, and also in acromegalic patients administered the drug subcutaneously or intramuscularly at 25-50 mg every day or every 2 days. The duration of treatment depends on the effectiveness of therapy and the nature of the disease. After improvement of clinical picture of Testosterone propionate administered in maintenance doses, 5-10 mg daily or every other day. When impotence endocrine Genesis, as well as male menopause, accompanied by vascular and nervous disorders, Testosterone propionate administered with 10 mg daily or 25 mg 2-3 times a week for 1-2 months. For the treatment of male infertility, the drug is used in doses of 10 mg 2 times a week for 4-6 months or 50 mg a day for 10 days. When male menopause, occurring pathologically, the drug is prescribed for 25 mg 2 times a week for 2 months with a month break.
Women over 45 years old with dysfunctional uterine bleeding prescribe 10-25 mg a day for 20 to 30 days to stop bleeding and the appearance of atrophic cells in the vaginal smears.
The dosage depends on the gender, age and disease.
Side effects. Priapism, increased sexual arousal, increased libido and frequent erections, gynecomastia, edema, hypercalcemia, dizziness, nausea. Boys – precocious puberty with increasing size of sexual organs, premature closure of the epiphyses of bones. May develop thrombophlebitis, cholestatic jaundice, increased levels of aminotransferase AZ, soreness at the injection site, redness and itching. Women may experience virilization (virilism): roughness of voice, excessive hair growth on the face and body, pasty face.
Seborrhea, acne, depression, sleep disorders, prostate cancer.
Contraindications. Hyper sensitivity to the drug, prostate cancer, breast cancer, gynecomastia, liver and kidney, hypercalcemia, heart failure, severe asthenia patients, old age men, pre puberty in boys, pregnancy and lactation in women. Breast cancer, nephrosis, protechna form of nephritis, diabetes mellitus, prostatic hypertrophy, urination disorders. Pregnancy and breast-feeding.
Overdose. In applying the drug in high doses or for a long time increasing side effects. In this case, cancel the drug, and after the disappearance of androgen-dependent side effects continue to apply in small doses. If necessary, symptomatic treatment.
Features of the application. During treatment necessary to monitor the condition of patients with heart failure, hypertension, epilepsy, migraine, violation of the kidney. Before use to heat up (30-40)°C. Under the deposition of crystals, the contents of the vial prior to injection should be heated in boiling water bath for 15-20 minutes. If the crystals disappear and the solution becomes clear and when cooled to (37±1)0C, the crystals falling out again, the drug unfit for use.
Interaction with other medicinal products. The combined use of substances that are inducers of microsomal liver enzymes – barbiturates, rifampicin, carbamazepine, phenylbutazone, phenytoin, effect of testosterone may weaken. At sharply expressed gogogadget Testosterone propionate can be combined with drugs that stimulate the function of the thyroid gland, estrogen. Enhances the effect of anabolic drugs, vitamins, preparations containing calcium, phosphorus. Enhances the action of indirect anticoagulants, hypoglycemic agents, cyclosporine. Alcohol suppresses the action of the drug.
The conditions and duration of storage. Store in a dark place under temperature from +15 °C to +25 °C. Freezing is not allowed .
Shelf life – 2 years.
Packing. 1 ml in ampoules No. 5.