Androgens.

Testosterone

Sustanon Ampoules: ampoules. Sustanon 250: ampoules.

Sustanon 100 is a clear, sterile, oily solution for deep intramuscular injection.

Testosterone replacement therapy in male hypogonadal disorders, for example: after castration; eunuchoidism; hypopituitarism; endocrine impotence; male climacteric symptoms like decreased libido; certain types of infertility due to disorders of spermatogenesis. Testosterone therapy may also be indicated for the prevention and treatment of osteoporosis in hypogonadal males

Dosage

In general, dosage should be adjusted to the individual response of the patient.

Adults:

Usually, one injection of 1ml per two weeks is adequate.

Administration

Deep intramuscular injection

It should be noted that smaller and less frequent doses may achieve the same response.

It should be noted that smaller and less frequent doses may achieve the same response.

Known or suspected prostatic or mammary carcinoma;

Pregnancy

Breast-feeding

Hypersensitivity to one of the excipients.

Patients, especially the elderly, with the following conditions should be monitored:

ischaemic heart disease, since androgens may produce hypercholesterolaemia.

latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions), since androgens may occasionally induce fluid and sodium retention.

skeletal metastases, since androgens may induce hypercalcaemia or hypercalciuria in these patients.

The use of steroids may influence the results of certain laboratory tests.

Androgens should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development.

If androgen-associated adverse reactions occur, Sustanon 100 treatment should be interrupted and, after disappearance of the symptoms, be resumed at a lower dosage.

Sustanon 100contains Arachis oil (peanut oil) and should not be taken / applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Sustanon 100.

Enzyme-inducing agents may exert increasing or decreasing effects on testosterone levels. Therefore adjustment of the dose, and/or intervals between injections may be required.

The following adverse reactions have been associated with androgen therapy in general:

• In prepubertal boys, precocious sexual development, an increased frequency of erections, phallic enlargement and premature epiphyseal closure;

• priapism and other signs of excessive sexual stimulation;

• Water and sodium retention;

• Oligospermia and a decreased ejaculatory volume.

Treatment should be interrupted until these symptoms have disappeared, after which it should be continued at a lower dosage.

Hoarseness of the voice may be the first symptom of vocal change which may lead to irreversible lowering of the voice. If signs of virilisation, particularly lowering of the voice, develop, treatment should be discontinued

Organon

(POM)

29 June 2009