"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.
New safety information from published literature and case reports on the risks "...
There were no reports of overdose in the Testim® clinical trials. There is a single report in the literature of acute overdosage after injection of testosterone enanthate. This subject had serum testosterone concentrations of up to 11,400 ng/dL, which were implicated in a cerebrovascular accident.
Treatment of overdosage would consist of discontinuation of Testim, washing the application site with soap and water, and appropriate symptomatic and supportive care.
- Testim is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see WARNINGS AND PRECAUTIONS].
- Testim is contraindicated in women who are or may become pregnant, or who are breastfeeding. Testim may cause fetal harm when administered to a pregnant woman. Testim may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with Testim. If a pregnant woman is exposed to Testim, she should be apprised of the potential hazard to the fetus [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].
Last reviewed on RxList: 11/9/2016
Additional Testim Information
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