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. Discard used TESTIM tubes in household trash in a manner that prevents accidental exposure of women, children, or pets see BOXED WARNING and WARNINGS AND PRECAUTIONS. The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application see CLINICAL PHARMACOLOGY. In order to prevent transfer to another person, wear clothing to cover the application sites. Avoid fire, flame or smoking during the application of TESTIM until the TESTIM has dried see WARNINGS AND PRECAUTIONS. The maximum recommended dose of TESTIM is 100 mg once daily. The active pharmacological ingredient in Testim is testosterone. 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. Your risk of prostate problems should be checked by your doctor before you start testosterone. Some men, especially older adults, are at a higher risk for developing enlarged prostates or prostate cancer while using this medication. If this medication accidentally gets into your eyes, rinse the eyes right away with clean, warm water. If a woman or child makes contact with the application area, that area on the woman or child should be washed well with soap and water right away. Women and children should avoid contact with the unwashed or unclothed area where the medication has been applied. Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. You may report side effects to FDA at FDA-1088 or at /medwatch. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Advise patients to carefully read the information brochure that accompanies each carton of 30 Testim® single-use tubes. Used Testim® tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable. In order to prevent transfer to another person, clothing should be worn to cover the application sites. Testim® contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. The preliminary results from these studies are consistent with those reported for the U.S. controlled clinical trial. In the combined ongoing U.S. and European open label extension studies, approximately 140 patients received Testim® for at least 6 months. It appears that in women, rather than testosterone, estradiol may be the most important hormone involved in sexual desire, although data on the clinical use of estradiol to increase sexual desire in women is limited. For this reason, and due to the unknown health effects and safety of testosterone therapy, its use may be inappropriate. In accordance, men experience sexual dysfunction at testosterone levels of below 300 ng/dL, and men that have levels of testosterone of approximately 200 ng/dL frequently experience such problems. These included decreased levels of total cholesterol, triglycerides, and high-density lipoprotein (HDL) cholesterol, and increased levels of low-density lipoprotein (LDL) cholesterol.
