SECONDARY EXPOSURE TO TESTOSTERONE
- Virilization has been reported in children who were secondarily exposed to testosterone gel [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
- Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS]
- Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].
Testim® (testosterone gel) is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. Testim provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms.
One 5-g or two 5-g tubes of Testim contains 50 mg or 100 mg of testosterone, respectively, to be applied daily to the skin's surface. Approximately 10% of the applied testosterone dose is absorbed across skin of average permeability during a 24-hour period.
The active pharmacological ingredient in Testim is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure:
Inactive ingredients in Testim are purified water, pentadecalactone, carbopol, acrylates, propylene glycol, glycerin, polyethylene glycol, ethanol (74%), and tromethamine.
What are the possible side effects of testosterone topical?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using testosterone topical and call your doctor at once if you have any of these serious side effects:
- burn-like blistering of the skin where the transdermal patch is worn;
- skin irritation with patch-wearing that does not get better with time;
- problems with urination;
- swelling of your ankles;
- frequent, prolonged, or bothersome erections; or
- nausea, stomach pain, low...
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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