Testosterone 1% Topical

Indications

Testosterone 1% Topical is used for: Hypogonadism, Testosterone replacement therapy

Adult Dose

Topical Adult: Testosterone gels: 50 mg/day initially, applied topically to shoulders, upper arms, or abdomen (not to genitals) each morning; titrated according to predose serum testosterone levels (25 mg/2.5 g, 50 mg/5 g); not to exceed 100 mg/day

Child Dose

Safety and efficacy not established

Renal Dose

Administration

Applying the gel to skin of lower abdomen, inner thighs or shoulders and upper arms, usually once daily.

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; use is contraindicated

Pregnancy-Lactation

Pregnancy category: X Lactation: Drug is excreted into breast milk; use is contraindicated

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.

Side Effects

Side effects of Testosterone 1% Topical : >10% Pruritus at application site (37%), Skin reactions at application site (16.1%), Blisters under skin (12%) 1-10% Erythema at application site (7%), Vesicles at application site (6%), Allergic contact dermatitis (4%), Burning at application site (3%), Induration at application site (3%) Frequency Not Defined Abnormal dreams, Acne, Anaphylaxis, Bladder irritability, Breast soreness, Cholestatic jaundice, Deep vein thrombosis, Dry skin, Fatigue, Gynecomastia, Headache, Insomnia, Menstrual irregularities, Priapism, Suppression of factors II, V, VII, Virilization

Mode 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.