Testosterone (Replacement)

VERBATIM UK SPC §4.2 (TESTOGEL 16.2 MG/G GEL, PL283970007): 'Adult and elderly men The recommended dose is two pump actuations of gel (i.e. 40.5 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the physician depending on the clinical or laboratory response in individual patients, not exceeding four pump actuations or 81 mg testosterone per day. The adjustment of posology should be achieved by increments of one pump actuation of gel.' §2: 'One gram of gel contains 16.2 mg testosterone. One pump actuation delivers 1.25 g of gel containing 20.25 mg of testosterone.' §4.2 on stopping: 'Therapy should be discontinued if the blood testosterone levels consistently exceeds the normal range at the lowest daily dose of 20.25 mg (1.25 g gel, equivalent to one pump actuation) or if blood testosterone levels in the normal range cannot be achieved with the highest dose of 81 mg (5 g gel, equivalent to four pump actuations).' Before the first dose the canister pump is primed by depressing the actuator three times and discarding the first three actuations. §4.1: 'indicated in adults for testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests'. Not indicated in women; safety and efficacy under 18 years not established. SCOPE — THIS PAGE NAMES SEVERAL PRODUCTS AND ROUTES (Testogel, Nebido IM depot, Testim gel, Tostran gel); ONLY the Testogel 16.2 mg/g PUMP GEL is dosed here. Other testosterone products in the class (including the Testogel 50 mg sachet, the Nebido intramuscular depot, Testim and Tostran) have different strengths, devices and regimens and are NOT covered by this source; the figures above must not be applied to them.