Testosterone Undecanoate

Indications

Testosterone Undecanoate is used for: Male hypogonadism

Adult Dose

Oral Male hypogonadism Adult: Initially, 120-160 mg daily of the undecylate ester followed by a maintenance dose of 40-120 mg daily.

Child Dose

Renal Dose

Administration

Contra Indications

Hypercalcaemia or hypercalciuria, males with breast or prostate carcinoma. Pregnancy and lactation.

Precautions

Cardiovascular disorders, skeletal metastases, renal or hepatic impairment, epilepsy, migraine, diabetes or other conditions which may be aggravated by fluid retention, eg heart failure. Elderly, prepubertal boys. Monitor signs of virilization (females) and development of priapism or excessive sexual stimulation (males). Periodic haemoglobin, lipid determinations and rectal prostate examination. Lactation: Drug is excreted into breast milk; avoid using

Pregnancy-Lactation

Pregnancy Contraindicated in pregnant women Teratogenic; may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action Exposure of a female fetus to androgens may result in varying degrees of virilization Animal data In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring These studies did not meet current standards for nonclinical development toxicity studies Infertility During treatment with large doses of exogenous androgens, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis Observed reduced fertility in some men taking testosterone replacement therapy; impact on fertility may be irreversible Lactation Not indicated for women

Interactions

Enhance activities of ciclosporine, antidiabetics, thyroxine, anticoagulants. Long term use of testosterone may cause resistance to effects of neuromuscular blockers. Enhance fluid retention from corticosteroids

Adverse Effects

Side effects of Testosterone Undecanoate : Fluid and electrolyte retention; increased vascularity of the skin; hypercalcaemia, impaired glucose tolerance; increased bone growth and skeletal weight; increase LDL cholesterol; increase haematocrit and fibrinolytic activity; headache, depression and GI bleeding. Males: spermatogenesis suppression, priapism, gynaecomastia, prostatic hyperplasia and accelerate growth of malignant prostate neoplasms. Females: suppression of lactation, ovarian activity and menstruation; virilization, clitoris hypertrophy, increased libido, oily skin, acne, hirsutism, male pattern baldness. Children: Closure of the epiphyses and stop linear growth in early puberty, symptoms of virilisation. Precocious sexual development, increased frequency of erection in boys, and clitoral enlargement in girls. Potentially Fatal: Peliosis hepatis, liver toxicity, malignant neoplasm.

Mechanism of Action

Testosterone is the principal endogenous androgen responsible for promoting the growth and development of male sexual organs and maintaining secondary sex characteristics in androgen-deficient males.