"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 is a single report of acute overdosage after parenteral administration of an approved testosterone product in the literature. This subject had serum testosterone concentrations of up to 11,400 ng/dL, which were implicated in a cerebrovascular accident. There were no reports of overdosage in the AndroGel 1.62% clinical trial.
Treatment of overdosage would consist of discontinuation of AndroGel 1.62%, washing the application site with soap and water, and appropriate symptomatic and supportive care.
- AndroGel 1.62% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
- AndroGel 1.62% is contraindicated in women who are or may become pregnant, or who are breastfeeding. AndroGel 1.62% may cause fetal harm when administered to a pregnant woman. AndroGel 1.62% 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 AndroGel 1.62%. If a pregnant woman is exposed to AndroGel 1.62%, she should be apprised of the potential hazard to the fetus [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].
Last reviewed on RxList: 11/7/2016
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