Monitor testosterone level at baseline & at regular intervals during treatment; tumours; personal or family history of breast &/or endometrial cancer; pre-existing conditions (MI, cardiac-, hepatic- or renal insufficiency, HTN, epilepsy, or migraine, DM, anti-coagulant therapy, sleep apnoea, adiposity or chronic lung diseases); statural growth & sexual development in pre-pubertal childn. Consider digital rectal exam of the prostate & PSA to exclude benign prostate hyperplasia or a sub-clinical prostate cancer; hematocrit & Hb to exclude polycythemia prior to treatment initiation, at quarterly intervals for the 1st 12 mth & yrly thereafter. Regularly monitor Hb & hematocrit LFTs & lipid profile in patients receiving long-term androgen therapy. Potential virilisation. Reports of thrombotic events (eg, DVT, pulmonary embolism, ocular thrombosis). May interfere w/ anti-doping testing. Subject to abuse & dependence. Consider hysterectomy & bilateral oophorectomy after 18-24 mth of testosterone treatment. Continued surveillance to detect osteoporosis in patients who have undergone oophorectomy; endometrial & ovarian cancer in patients on long term treatment who have not proceeded to hysterectomy & bilateral oophorectomy. May lead to fertility disorders in men & infrequent or repressed menstrual cycle in women. Not to be given to premature babies or neonates. May cause toxic & anaphylactoid reactions in infants & childn <3 yr. Safety & efficacy have not been adequately determined in childn & adolescents. Limited experience on safety & efficacy >65 yr.
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