Treatment of hypogonadal men with Sustanon results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone, oestradiol and androstenedione, as well as a decrease of SHBG (sex hormone binding globulin). Luteinising hormone (LH) and follicle-stimulating hormone (FSH) are restored to the normal range. In hypogonadal men, treatment with Sustanon results in an improvement of testosterone deficiency symptoms. Moreover, treatment increases bone mineral density and lean body mass, and decreases body fat mass. Treatment also improves sexual function, including libido and erectile function. Treatment decreases serum LDL-C, HDL-C and triglycerides, increases haemoglobin and hematocrit, whereas no clinically relevant changes to PSA have been reported. Treatment may result in an increase in prostate size, but no adverse effects on prostate symptoms have been observed. In hypogonadal diabetic patients, improvements of insulin sensitivity and/or reduction in blood glucose have been reported with the use of androgens.
In female to male transsexuals treatment with androgens/Sustanon induces masculinisation.
Sustanon ‘250’ contains 4 esters of testosterone with different duration of action. The esters are hydrolysed into the natural hormone testosterone as soon as they enter the general circulation.
A single dose of Sustanon ‘250’ leads to an increase of total plasma testosterone with peak-levels of approximately 70 nmol/L (Cmax), which are reached approximately 24-48 h (tmax) after administration. Plasma testosterone levels return to the lower limit of the normal range in males in approximately 21 days.
Testosterone displays high binding (over 97%) to plasma proteins and sex hormone binding globulin.
Testosterone is metabolized to dihydrotestosterone and oestradiol, which are further metabolised via the normal pathways.
Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone.
DOSAGE AND ADMINISTRATION
In general, dosage should be adjusted according to the response of the individual patient.
Adults including elderly: Usually, one injection of 1mL per three weeks is adequate for Sustanon ‘250’.
Sustanon should be administered by deep intramuscular injection.
Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with Sustanon should be treated with caution. Sustanon contains benzyl alcohol and should not be given to children under 3 years of age.
The acute toxicity of testosterone is low. There are no specific recommendations for the management of overdosage with Sustanon. If symptoms of chronic overdose occur (e.g. polycythemia, priapism) treatment should be discontinued and after disappearance of the symptoms, be resumed at a lower dosage.
PRESENTATION AND STORAGE CONDITIONS
Each mL of the oily solution contains:
testosterone propionate 30mg
testosterone isocaproate 60mg
testosterone decanoate 100mg
testosterone phenylpropionate 60mg
Store below 30ºC. Do not refrigerate and protect from light. Store in the original packaging and keep container in the outer carton.
Since an opened ampoule cannot be resealed in such a way to further guarantee the sterility of the contents, the solution should be used immediately