Androgen therapy should be administered cautiously in patients with coronary artery disease or a history of ischemic heart disease. Treat overdoses by stopping testosterone products, washing off any topical products with soap and water, and initiating symptomatic and supportive treatments. Striant and its active metabolite dihydrotestosterone (DHT) antagonize the androgen receptor to develop masculine sex organs including the prostate, seminal vesicles, penis, and scrotum. Counsel patients regarding the risk of secondary exposure of testosterone topical products to children.
The mean maximum (Cmax) and mean average serum total testosterone concentrations for the 12 hour dosing period (Cavg(0-12)) are within the normal physiologic range. When applied to the buccal mucosa, Striant releases testosterone, allowing for absorption of testosterone through gum and cheek surfaces that are in contact with the buccal system. Oral ingestion of Striant is not expected to result in clinically significant serum testosterone concentrations due to extensive first-pass (hepatic) metabolism. There is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer. The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease.
It is prescribed to treat conditions caused by a lack of testosterone production, such as primary and secondary hypogonadism. Some studies have reported that Striant therapy might increase the risk of a heart attack in men age 65 and older, as well as in younger men who have a history of heart disease. In most cases, the infertility caused by testosterone treatment is reversible. Men who have prostate cancer or breast cancer should not take Striant replacement therapy. With the higher levels of energy and improved muscle mass Striant replacement therapy brings, you'll also have more stamina and strength to last longer during sex. However, research has also linked Striant therapy with several side effects and possible complications. Potential benefits include improved libido, increased bone mass, and increased sense of well-being.
Improper use of testosterone may affect bone growth in children. It is not known if Striant is safe or effective to treat men who have low testosterone due to aging. Striant is used to treat adult males who have low or no testosterone due to certain medical conditions.
If a venous thromboembolic event is suspected, discontinue treatment with Striant and initiate appropriate workup and management see Adverse Reactions (6.2). Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone.
Levels of testosterone are naturally much higher in men than in women. Healthcare providers prescribe them for certain conditions, such as male hypogonadism and certain types of breast cancer. Testosterone is under development in a low-dose intranasal formulation for the treatment of anorgasmia in women. Otherwise considered an adverse effect of testosterone, reduced spermatogenesis can be further suppressed with the addition of a progestin such as norethisterone enanthate or levonorgestrel butanoate, improving the contraceptive effect. Testosterone, as esters such as testosterone undecanoate or testosterone buciclate, has been studied and promoted as a male contraceptive analogous to estrogen-based contraceptives in women.
Testosterone buccal tablets and pellet implants do not appear to be available in Canada. As of November 2016update, testosterone is available in Canada in the form of topical gels (AndroGel, Testim), topical solutions (Axiron), transdermal patches (Androderm), and intranasal gels (Natesto). Unlike in Europe, Canada, and much of the rest of the world, oral testosterone undecanoate is not available in the United States. Unmodified testosterone was also formerly available for intramuscular injection but was discontinued. There is a medical condition called late-onset hypogonadism; according to Thomas Perls and David J. Handelsman, writing in a 2015 editorial in the Journal of the American Geriatrics Society, it appears that this condition is overdiagnosed and overtreated. Intramuscular testosterone undecanoate was not introduced in Europe and the United States until much later (in the early to mid 2000s and 2014, respectively). In the 1970s, testosterone undecanoate was introduced for oral use in Europe, although intramuscular testosterone undecanoate had already been in use in China for several years.
Testosterone therapy is effective in the short-term for the treatment of hypoactive sexual desire disorder (HSDD) in women. The FDA has required that labels on testosterone include warnings about increased risk of heart attacks and stroke. The primary use of testosterone is the treatment of males with too little or no natural testosterone production, also termed male hypogonadism or hypoandrogenism (androgen deficiency). Common side effects of testosterone include acne, swelling, and breast enlargement in men. The recommended dose of testosterone for the treatment of hypogonadism in males is 50 to 400 mg every 2 to 4 weeks. The recommended dose of testosterone gel for the treatment of hypogonadism in males is 50 to 100 mg daily applied to the skin. Serious side effects have been reported with testosterone.

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