Testosterone Mix Injection 250mg/ml
Composition:
Each ml Contains:
Testosterone Propionate USP 50mg
Testosterone Isocaproate BP 50mg
Testosterone Decanoate BP 100mg
Testosterone Phenylypropionate BP 50mg
Oil Base q.s
Pharmacokinetics:
Dynaston 250 contains four esters of testosterone with different durations of action. The esters are hydrolysed into the natural hormone testosterone as soon as they enter the general circulation.
Absorption:
A single dose ofDynaston 250 leads to an increase of total plasma testosterone with peak levels of approximately 70nmol/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.
In female-to-male transsexuals, a single dose ofDynaston 250 repeated every two weeks resulted in mean trough testosterone levels towards theupperend ofthenormalmalerange at 2, 4and 12 months.
Distribution:
Testosterone displays a high ( over 97%) non-specific binding to plasma proteins and sex hormone binding globulin in in vitro tests. Biotransformation:
Testosterone is metabolised to dihydrotestosterone and estradiol, which are further metabolised via the normal pathways.
Elimination:
Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone.
INDICATIONS:
Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. Testosterone administration may also be used as supportive therapy for female-tCrmale transsexuals.
CONTRA-INDICATIONS:
Pregnancy:
Known or suspected carcinoma of the prostate or breast Breast-feeding.
Hypersensitivity to the active substance or to any of the excipients including arachis oil. Dynaston 250 is therefore contraindicated in patients allergic to peanuts or soya.
WARNING:
Medical examination:
Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels. Physicians should consider monitoring patients receiving Dynaston 250 before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:
Digital rectal examination (DRE) of the prostate and PSA to exclude benign prostate hyperplasia or a sub-clinical p􀃗ostate cancer Haematocrit and haemoglobin to exclude polycythaemia. In patients receiving long-term androgen therapy, the followmg laboratory
parameters should also be monitoredregularly: haemoglobin, and haematocrit, liver function tests and lipid profile.