Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication. Subjects could be counted in both TESTIM treatment groups if they received both 50 mg and 100 mg at different points in the study and experienced an adverse reaction at both doselevels. To ensure proper dosing, serum testosterone concentrations should be measured. The recommended starting dose of Testim is 5 g of gel (one tube) containing 50 mg of testosterone applied once daily (preferably in the morning) to clean, dry intact skin of the shoulders and/or upper arms. Common side effects of testosterone include acne, swelling, and breast enlargement in men. If this occurs, the child may have unwanted side effects due to testosterone gel. Children accidentally exposed to this medication by direct contact with someone using it may absorb this drug through their skin. The number of days with spontaneous erections increased by 137% at Day 30 and was maintained at 78% at Day 90 for Testim®-treated patients compared to baseline. This medicated gel contains testosterone. In the first four groups, 100 mg of Testim® was applied to the male abdomen and the couples were then asked to rub abdomen-to-abdomen for 15 minutes at 1 hour, 4 hours, 8 hours or 12 hours after dose application, respectively. The potential for dermal testosterone transfer following Testim® use was evaluated in two clinical trials with males dosed with Testim® and their untreated female partners. These parameters included sexual motivation, sexual desire, sexual activity and spontaneous erections. At Day 30, patients receiving Testim® 100 mg daily showed significant improvement from baseline in multiple sexual function parameters as measured by patient questionnaires when compared to placebo. The study was double-blind for the doses of Testim® and placebo, but open label for the non-scrotal testosterone transdermal system. Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. The following adverse reactions have been identified during post-approval use of testosterone gel products. In a controlled clinical study, 304 patients were treated with TESTIM 50 mg or 100 mg or placebo gel for up to 90 days. TESTIM (testosterone gel)for topical use is available in a unit-dose tube. The application site and dose of TESTIM are not interchangeable with other topical testosterone products. The recommended starting dose of TESTIM is 50 mg of testosterone (one tube) applied once daily (preferably in the morning) to clean, dry intact skin of the shoulders and/or upper arms. Approximately 10% of the applied testosterone dose is absorbed across skin of average permeability during a 24-hour period. This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels. Of 192 hypogonadal men who were appropriately titrated with Testim® and who had sufficient data for analysis, 74% achieved an average serum testosterone level within the normal range on treatment Day 90. During the first 60 days, patients were evenly randomized to Testim® 50 mg, Testim® 100 mg, placebo gel, or testosterone transdermal system. Testim® was evaluated in a randomized multicenter, multi-dose, active and placebo controlled 90-day study in 406 adult males with morning testosterone levels ≤300 ng/dL. In patients treated with Testim® there are no observed differences in the average daily serum testosterone concentration at steady-state based on age or cause of hypogonadism. Call your doctor for medical advice about side effects. If you notice other effects not listed above, contact your doctor or pharmacist. This is not a complete list of possible side effects. A very serious allergic reaction to this drug is rare. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur. Your doctor may need to adjust your diabetes medications. Symptoms of low blood sugar include shakiness, nervousness, rapid pulse, and sweating. Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. In a controlled clinical study, 304 patients were treated with Testim® 50 mg or 100 mg or placebo gel for up to 90 days. Transfer of testosterone to another person can occur when vigorous skin-to-skin contact is made with the application site (See Clinical Studies). Pregnant and nursing women should avoid skin contact with Testim® application sites on men. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Virilization has been reported in children who were secondarily exposed to testosterone gel.
