AndroGel

OVERDOSE

There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone concentrations of up to 11,400 ng/dL with a cerebrovascular accident.

Treatment of overdosage would consist of discontinuation of AndroGel 1%, washing the application site with soap and water, and appropriate symptomatic and supportive care.

CONTRAINDICATIONS

  • AndroGel 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and Nonclinical Toxicology].
  • AndroGel 1% is contraindicated in women who are or may become pregnant, or who are breastfeeding. AndroGel 1% may cause fetal harm when administered to a pregnant woman. AndroGel 1% may cause serious adverse reactions in nursing infants. Exposure of a female 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%. If a pregnant woman is exposed to AndroGel 1%, she should be apprised of the potential hazard to the fetus [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Last reviewed on RxList: 7/7/2014
This monograph has been modified to include the generic and brand name in many instances.

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