Testosterone Decanoate

Each 1 ml ampoule contains:

• Testosterone propionate 30 mg
• Testosterone phenylpropionate 60 mg
• Testosterone isocaproate 60 mg
• Testosterone decanoate 100 mg in 1 ml arachis oil

All four compounds are esters of the natural hormone testosterone. The oily solution also contains 10 percent benzyl alcohol.

Testosterone is the principal endogenous hormone essential for normal growth and development of the male sex organs and male secondary sex characteristics. During adult life testosterone is essential for the functioning of the testes and accessory structures and for the maintenance of libido, sense of well-being, erectile potency, prostate and seminal vesicle function.

Treatment of hypogonadal men with Testanon results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone and androstenedione, as well as a decrease of SHBG (sex hormone binding globulin). In males with primary (hypergonadotropic) hypogonadism treatment with Testosterone Decanoate results in a normalization of gonadotropin levels. Treatment of female-to-male transsexuals with Testosterone Decanoate results in a clinically significant rise of plasma testosterone levels, a decrease of LH and FSH levels and a decrease in SHBG level.

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

Adults: Usually, one injection of 1 ml per three weeks is adequate. Testosterone should be administered by deep intramuscular injection.

Children: Safety and efficacy have not been adequately determined in children and adolescents.

Testosterone contains benzyl alcohol and should not be given to children under 3 years of age.

Enzyme inducing agents may exert increasing or decreasing effects on Testosterone levels. Therefore, adjustment of dose or intervals between injections may be required.

Testosterone is contraindicated in case of known hypersensitivity to Testosterone or any of its components. It is also contraindicated in patient with known and suspected prostatic carcinoma or breast carcinoma in male.

The most common side effects of Testosterone therapy are precocious sexual development, increased frequency of erections, phallic enlargement and premature epiphyseal closure, priapism, oligospermia, decreased ejaculatory volume and fluid & sodium retention.

Pregnancy: There are no adequate data for the use of Testosterone in pregnant women. In view of the risk of virilization of the foetus, Testosterone should not be used during pregnancy. Treatment with Testosterone should be discontinued when pregnancy occurs.

Lactation: There are no adequate data for the use of Testosterone during lactation. Therefore, Testosterone should not be used during lactation.

Androgens should be used with caution in pre (pubertal) boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly. Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced. Androgens should be used with caution in men suffering from benign prostatic hyperplasia. The use of steroids may influence the results of certain laboratory tests. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.

The acute intramuscular toxicity of Testosterone is very low. Priapism in men is a symptom of chronic over dosage. If this occurs, treatment should be interrupted and after disappearance of the symptom, be resumed at a lower dosage.

Male Sex hormones (Androgens)

Store in a cool (between 8º C to 30º C) and dry place protected from light. Keep out of the reach of children.