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Androtardyl

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Indications:

in men Replacement therapy in primary hypogonadism and hypogonadotropic hypogonadism,in women Ablation of ovaries in metastatic breast cancer

Contraindications:

Hypersensitivity to product; serious cardiac, hepatic, or renal disease; men with carcinoma of breast or prostate; women who are or may become pregnant; testosterone gel and buccal system are contraindicated in women.

Adverse reactions:

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. IM: urticaria, inflammation at Inj site, postinjection induration, furunculosis. Transdermal: local irritation. Buccal: Gum irritation, bitter taste, gum pain, tenderness. Potentially Fatal: Peliosis hepatis, liver toxicity, malignant neoplasm.

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.

Warnings:

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.Category X in pregnancy.

Form:

SOLUTION FOR INJECTION

Dosage and Administration

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