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Testosterone undecanoate is an ester of natural androgen, testosterone. The active form, testosterone, results from cleavage of the side chain.
Testosterone plays a key role in male sexual differentiation and is involved in regulation of hematopoiesis, body composition, and bone metabolism. As a result, testosterone replacement therapy in males with hypogonadism can result in improved sexual function, increased lean body mass, bone density, erythropoiesis, prostate size, and changes in lipid profiles.
Testosterone is produced by Leydig cells and exerts it’s effects by binding to androgen receptors throughout the body.
Testosterone is the primary androgenic hormone synthesized and released by the testicles. It is responsible for the growth and development of male sexual organs and secondary sexual characteristics (maturation of prostate, seminal vesicles, penis and scrotum), male hair distribution (face, pubis, chest), laryngeal development, body muscles and fat distribution. Retains nitrogen, sodium, potassium and phosphorus in the body, increases anabolism and reduces protein catabolism. The premature increase in testosterone plasma concentration in the prepubertal period causes the epiphysis to close and stop growth. Stimulates the production of erythropoietin and erythrocytes. The feedback mechanism inhibits the secretion of luteinizing hormones and pituitary-like pituitary glands and causes the suppression of spermatogenesis.
In women inhibits pituitary gonadrophic function, ovarian function, mammary glands, causes endometrial atrophy. Due to estrogen antagonist action, it is used in the treatment of uterine miosis, endometriosis, breast cancer. It manifests beneficial action during the climacteric period.
Like all medicines, Undeconoate can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. The most common side effects (may affect up to 1 in 10 people) are acne, abnormally high abnormal red blood cell counts, weight gain, hot flashes, increase in prostate specific antigen (increase of a biochemical index in the blood), increased prostate size and associated problems, increased erections and pain at the site of administration.
An ampoule of Testosterone U (corresponding to 1000 mg of testosterone undecanoate) is injected every 10-14 weeks. This frequency of administration is effective in maintaining a sufficient concentration of testosterone and does not produce accumulation of the drug.
Injections should be performed very slowly. Testosterone U is injected strictly intramuscularly. Particular attention should be paid to avoiding intravascular injection.