Solution for injection
A clear, pale yellow solution
4.1 Therapeutic 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-to-male transsexuals.
In general, the dose should be adjusted to the response of the individual patient.
Usually, one injection of 1ml per 3 weeks is adequate.
Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with Sustanon 250 should be treated with caution
Different specialist centres have used doses varying from one injection of 1ml every two weeks to one injection of 1ml every four weeks.
Method of administration
Sustanon 250 should be administered by deep intramuscular injection.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including arachis oil. Sustanon 250 is therefore contraindicated in patients allergic to peanuts or soya
laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, liver function tests and lipid profile.
Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria may develop spontaneously, also during androgen therapy. The latter can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia or hypercalciuria should first be treated appropriately and after restoration of normal calcium levels, hormone therapy can be resumed.
• Pre-existing conditions
In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such cases treatment must be stopped immediately. Patients who experienced myocardial infarction, cardiac-, hepatic- or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration of or reoccurrence of disease. In such cases treatment must be stopped immediately.
Testosterone may cause a rise in blood pressure and Sustanon 250 should be used with caution in men with hypertension.
• Epilepsy or Migraine
since androgens may occasionally induce fluid and sodium retention.
• Diabetes mellitus
Androgens in general and Sustanon 250 can improve glucose tolerance in diabetic patients
• Anti-coagulant therapy
Androgens in general and Sustanon 250 can enhance the anti-coagulant action of coumarin-type agents
• Sleep apnoea
Caution should be applied when treating men with sleep apnoea. There have been reports that testosterone can cause or exacerbate pre-existing sleep apnoea. However, there is a lack of evidence regarding the safety of testosterone in men with the condition. Good clinical judgment and caution should be employed in patients with risk factors such as adiposity or chronic lung diseases.