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AndroGel®
(testosterone gel) 1% for Topical Use

WARNING: 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 WARNINGS AND PRECAUTIONS].

Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

AndroGel (testosterone gel) 1% is a clear, colorless hydroalcoholic gel containing 1% testosterone. Topical administration of AndroGel 5 g, 7.5 g, or 10 g contains 50 mg, 75 mg, or 100 mg of testosterone, respectively, is 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 pharmacologic ingredient in AndroGel is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is:

AndroGel®
  (testosterone) Structural Formula Illustration

Inactive ingredients in AndroGel are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active.

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...

Read All Potential Side Effects and See Pictures of AndroGel »

What are the precautions when taking testosterone gel for topical use (AndroGel)?

Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soy), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: breast cancer (males), prostate cancer.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, prostate problems (e.g., enlarged prostate or BPH), heart problems, kidney problems, diabetes, high cholesterol level, lung disease, obesity, difficulty breathing during sleep (apnea), high blood...

Read All Potential Precautions of AndroGel »

Last reviewed on RxList: 12/12/2011
This monograph has been modified to include the generic and brand name in many instances.