Formulation and Dosage Form
Solution translucent, pale yellow Each ml contains:
Testosterone Propionate 30 mg
60 mg testosterone phenylpropionate
60 mg testosterone isocaproate
Testosterone decanoate 100 mg
Vehicle c.b.p. 1 ml.
Dosage and administration
Parenteral (deep intramuscular). Usually, the administration of an injection of 1 ml every 3 weeks is sufficient. Sostenon 250 ® should be administered by deep intramuscular injection. In general, the dosage should be adjusted according to individual patient response. Safety and efficacy have not been adequately determined in children. Sostenon 250 ® contains benzyl alcohol and should not be administered to children under 3 years old.
INDICATIONS: Hormone androgen.
• Testosterone replacement therapy in males for conditions associated with primary and secondary hypogonadism, either congenital or acquired.
Pharmacotherapeutic group: Androgens.
G03B ATC code A03.
Pharmacokinetics Sostenon 250® contains four testosterone esters with different durations of action. The esters are hydrolyzed in the natural hormone testosterone just entering the general circulation.
Absorption: A single dose of Sostenon 250® produces increased plasma total testosterone levels with maximum around 70 nmol / l (C max.), Which are reached in about 24-48 hours after administration (Tmax.) .
Plasma testosterone levels return to the lower limit of the normal range in men approximately 21 days.
Distribution: In vitro tests, testosterone has a high binding (over 97%) non-specific plasma protein and sex hormone binding globulin.
Biotransformation is metabolized testosterone to dihydrotestosterone and estradiol, which are then metabolized through normal channels.
Elimination is mainly excreted in the urine as conjugates of etiocholanolone and androsterone.
Pharmacodynamics: The treatment of hypogonadal men with Sostenon 250® produce a clinically significant increase in plasma concentrations of testosterone, dihydrotestosterone, estradiol and androstenedione, as well as a decrease in SHBG (sex hormone binding globulin).
The levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are restored to the normal range.
In hypogonadal men, Sostenon 250® treatment results in improvement of the symptoms of testosterone deficiency. Also, the treatment increases bone mineral density and lean body mass and decreases body fat mass.
The treatment also improves sexual function, including libido and erectile function. The treatment reduces serum levels of LDL-C, HDL-C and triglycerides, increases hemoglobin and hematocrit, while there are no reported clinically significant changes in liver enzymes and PSA. The treatment can result in an increased size of the prostate, although there are no observed effects on prostate symptoms.
In hypogonadal patients with diabetes, has been reported to increase insulin sensitivity and / or lowering blood glucose with androgen use.
In boys with constitutional delay of growth and puberty, androgen treatment accelerates growth and induces the development of secondary sex characteristics.
In female-male transsexuals, androgen treatment / Sostenon 250® produces masculinization.