erone deficiency after puberty. safety and efficacy of testosterone enanthate injection, usp in men with age-related hypogonadism have not been established. delayed puberty – testosterone enanthate injection, usp may be used to stimulate puberty in carefully selected males with clearly delayed puberty. these patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. the potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. an x-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers (see warnings ). females metastatic mammary cancer – testosterone enanthate injection, usp may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. primary goals of therapy in these women include ablation of the ovaries. other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. this treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. judgment concerning androgen therapy should be made by an oncologist with expertise in this field.

us thromboembolic events, including deep vein thrombosis (dvt) and pulmonary embolism (pe), in patients using testosterone products, such as testosterone enanthate injection. 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 a venous thromboembolic event is suspected, discontinue treatment with testosterone enanthate injection and initiate appropriate workup and management . long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. to date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (mace), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. some studies, but not all, have reported an increased risk of mace in association with use of testosterone replacement therapy in men. patients should be informed of this possible risk when deciding whether to use or to continue to use testosterone enanthate injection. testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic steroids. anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions (see drug abuse and dependence ). if testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. however, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic steroids. conversely, consider the possibility of testosterone and anabolic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. due to sodium and water retention, edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. in addition to discontinuation of the drug, diuretic therapy may be required. if the administration of testosterone enanthate is restarted, a lower dose should be used. gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism. androgen therapy should be used cautiously in healthy males with delayed puberty. the effect on bone maturation should be monitored by assessing bone age of the wrist and hand every six months. in children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. this adverse effect may result in compromised adult stature. the younger the child the greater the risk of compromising final mature height.

wet needle or wet syringe may cause the solution to become cloudy; however this does not affect the potency of the material. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. testosterone enanthate injection is a clear, colorless to pale yellow solution. male hypogonadism: as replacement therapy, i.e., for eunuchism, the suggested dosage is 50 to 400 mg every 2 to 4 weeks. in males with delayed puberty: various dosage regimens have been used; some call for lower dosages initially with gradual increases as puberty progresses, with or without a decrease to maintenance levels. other regimens call for higher dosage to induce pubertal changes and lower dosage for maintenance after puberty. the chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. dosage is within the range of 50 to 200 mg every 2 to 4 weeks for a limited duration, for example, 4 to 6 months. x-rays should be taken at appropriate intervals to determine the amount of bone maturation and skeletal development (see indications and usage and warnings ). palliation of inoperable mammary cancer in women: a dosage of 200 to 400 mg every 2 to 4 weeks is recommended. women with metastatic breast carcinoma must be followed closely because androgen therapy occasionally appears to accelerate the disease.

r neoplasms, peliosis hepatis (see warnings ). hematologic – suppression of clotting factors ii, v, vii, and x; bleeding in patients on concomitant anticoagulant therapy; polycythemia. nervous system – increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. metabolic – increased serum cholesterol. vascular disorders – venous thromboembolism miscellaneous – rarely, anaphylactoid reactions; inflammation and pain at injection site. to report suspected adverse reactions, contact hikma pharmaceuticals usa inc. at 1-877-845-0689 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .

rates but may cause a disproportionate advancement in bone maturation. use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. androgens have been reported to stimulate the production of red blood cells by enhancing the production of erythropoietic stimulating factor. during exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (lh). at large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (fsh). there is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding.

iderable variations of the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes. in responsive tissues, the activity of testosterone appears to depend on reduction to dihydrotestosterone (dht), which binds to cytosol receptor proteins. the steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action.