INN of the active substance:
Composition of the preparation:
1 ml solution contains:
Active ingredient: testosterone Enanthate 250 mg;
Additional ingredients: benzyl alcohol, benzil benzoate, peaches and peanut oil.
Description of preparation:
Transparent oily solution color from light yellow to yellow with characteristic odor.
The oily solution injectable.
Pharmacotherapeutic group and ATC code
Androgen, G03B A03.
Testosterone Enanthate is an ester of testosterone. Testosterone is the primary androgenic hormone synthesized and released by the testes. Is responsible for the growth and development of male sex organs and secondary sexual characteristic features (aging prostate, seminal vesicles, penis, and scrotum), male hair distribution (face, groin, chest) develop laryngeal muscle and body fat distribution. Remember nitrogen, sodium, potassium and phosphorus, increase anabolism and decrease protein catabolism. The premature increase in serum testosterone in prepubertal epiphyseal closure and causes growth arrest. And Erythropoietin stimulates red blood cell production. The feedback mechanism inhibits the pituitary secretion of luteinizing hormone and follicle and causes suppression of spermatogenesis.
Women inhibit pituitary function, ovarian function, mammary glands, endometrial atrophy. Due to the action of estrogen antagonists used in the treatment of uterine myoma, endometriosis, breast cancer. Exhibit beneficial during the climacteric.
Testosterone Enanthate is slowly absorbed. Maximum plasma concentration are achieved in 72 hours after intramuscular administration. Duration of action - 2-4 weeks. In the blood about 98% of testosterone was coupled with a specific globulin fraction, which binds testosterone and estradiol. Biotransformation occurs in the liver to various 17-ketosteroizi that after conjugation with glucuronic or sulfuric acid is eliminated with urine (about 90%). Approximately 6% of the preparation is eliminated with feces absorbed in free-form.
At men - hormone replacement therapy in disorders caused by testosterone deficiency:
• retention of sexual maturation;
• eunuchoidism, underdevelopment of genitals;
• impotence hormonal origin;
• symptoms of male climax (decreased libido and physical and intellectual activity);
• post castrating syndrome (androgenic deficit after castrating);
• osteoporosis caused by androgenic insufficiency.
• hyperestrogenemia, functional bleeding;
• uterine myoma;
• menopause (in combination with estrogen);
• breast cancer;
Dosage and method od administration:
Deep intramuscular injection. The dosage is determined individually depending on the disease, sex, age, clinical efficacy.
Typically, for adults 50-200 mg is administered intramuscularly once 2-4 weeks. It is not recommended to exceed 400 mg per month. Duration of treatment is determined individually.
In hypogonadal men as the eunuchoidism recommended dosages are 50-400 mg every 2-4 weeks.
In the case of retaining sexual maturation is administered by 50-200 mg every 2-4 weeks for 4-6 months.
Inoperable breast cancer in women by 200-400 mg every 2-4 weeks.
The drug should not be used intravenously!
• Priapism and other symptoms of sexual hyperstimulation (frequent erection);
• prepubertal age teenagers - accelerated sexual development; increased frequency of erections, increased sexual organ size, premature epiphyseal closure;
• impaired spermatogenesis and sperm maturation disorder, oligospermia and reduced volume of ejaculate;
• abnormalities of the prostate;
• Women - bleeding from the genital tracts, increased libido; Prolonged administration of virilization symptoms are possible;
• hirsutism, gynecomastia;
• seborrhea, acne, oily skin, hair loss;
• sodium and water retention, edema;
• Symptoms of hypercalcemia;
• Nausea, cholestatic jaundice, increase in liver transaminases (normalized upon discontinuation);
• headaches, depression, aggression, anxiety, sleep disorders, numbness.
Possible pain, itching and redness at the injection site.
Individual hypersensitivity to the drug, prostate and breast carcinoma; prostate hyperplasia micturition disorder symptoms; nephrosis or the nephrotic phase of nephritis, edema; hypercalcemia; disturbances of liver function; diabetes; heart failure or coronary, myocardial infarction, atherosclerosis in elderly men; pregnancy, lactation.
In acute overdose, the testosterone toxicity is very low.
In chronic overdose is possible to develop priapism. In this case, it is necessary to stop taking preparation, and after symptoms - resume with lower doses.
WARNINGS AND SPECIAL PRECAUTIONS FOR USE
In case of adverse reactions necessary for androgen-dependent stop taking the preparation. After the disappearance of side effects in the treatment resume with lower doses.
Patients with latent or overt cardiac failure, impaired renal function, hypertension, epilepsy or migraine (or a history of the presence of these states) will be under constant supervision because androgens may cause sodium retention and in some cases water. The treatment duration will monitor liver function. At breast cancer patients, hipernefrom lung cancer bone metastases will control the level of calcium in the blood and urine. Androgens in prepubertal adolescents should be given with caution to avoid premature cessation of growth and puberty.
Interactions with other drugs:
Increase the effectiveness of anticoagulants and antidiabetic (dose adjustment is required), inhibits cyclosporine elimination. Hepatic enzyme inducers (barbiturates, rifampin, carbamazepine, phenylbutazone, phenytoin) reduce the effect of testosterone.
The oily solution injectable 250 mg / ml in 1 ml ampoules.
Store in a dry place protected from light, at a temperature of 15-25 ° C.
Keep out of the reach and sight of children.
5 years. Do not use after the expiration date indicated on the packaging.