Testosterone undecanoate steroidology

Adverse effects of testosterone supplementation may include increased cardiovascular events (including strokes and heart attacks ) and deaths based on three peer-reviewed studies involving men taking testosterone replacement. [51] In addition, an increase of 30% in deaths and heart attacks in older men has been reported. [52] Due to an increased incidence of adverse cardiovascular events compared to a placebo group , a Testosterone in Older Men with Mobility Limitations (TOM) trial (a National Institute of Aging randomized trial) was halted early by the Data Safety and Monitoring Committee . [53] On January 31, 2014, reports of strokes , heart attacks , and deaths in men taking FDA-approved testosterone-replacement led the FDA to announce that it would be investigating the issue. [54] Later, in September 2014, the FDA announced, as a result of the "potential for adverse cardiovascular outcomes", a review of the appropriateness and safety of Testosterone Replacement Therapy (TRT). [55] [56] [57] The FDA now requires warnings in the drug labeling of all approved testosterone products regarding deep vein thrombosis and pulmonary embolism . [58]

The advantage of injecting a single large bolus, rather than two or more smaller depots, is that a large globule releases the drug much more slowly. 31 Within muscle cells, fat or oil tends to form a spherical globule. One large globule better protects the drug inside, insulating TU from esterases— enzymes that release testosterone from the pro-drug ester. TU increases testosterone concentration only after it is released from its attached ester. It appears as though the . version will be administered as a 3 ml injection, every 10 weeks. 22,24

From the lymphatic system testosterone undecanoate is released into the plasma. Single administration of 20-80 mg Restandol Testocaps to postmenopausal women leads to peak-levels of total plasma testosterone of approximately -, - and -/ml after a dose of 20, 40 and 80 mg Restandol Testocaps, respectively . These levels are reached approximately 5-6 h (t max ) after administration. Plasma testosterone levels remain elevated for at least 8 hours. In Japanese women the testosterone levels are about two fold higher.

• Evaluate formulation-specific ad­verse effects at each visit:
- Intramuscular injections of testosterone enanthate and cypionate: Ask about fluctuations in mood or libido.
- Testosterone patches: Look for skin reaction at the application site.
- Testosterone gels: Advise patients to cover the application sites with a shirt and to wash the skin with soap and water before having skin-to-skin contact because testosterone gel leaves a residue on the skin that can be transferred to a woman or child who comes in close contact. Serum testosterone levels are main­tained when the site is washed 6 hours after applying the gel.

Testosterone undecanoate steroidology

testosterone undecanoate steroidology

• Evaluate formulation-specific ad­verse effects at each visit:
- Intramuscular injections of testosterone enanthate and cypionate: Ask about fluctuations in mood or libido.
- Testosterone patches: Look for skin reaction at the application site.
- Testosterone gels: Advise patients to cover the application sites with a shirt and to wash the skin with soap and water before having skin-to-skin contact because testosterone gel leaves a residue on the skin that can be transferred to a woman or child who comes in close contact. Serum testosterone levels are main­tained when the site is washed 6 hours after applying the gel.

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