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.
Additional Testim Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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