"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 "...
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].
AndroGel 1.62% for topical use is a clear, colorless gel containing testosterone. Testosterone is an androgen. AndroGel 1.62% is available in a metered-dose pump or unit dose packets.
The active pharmacologic ingredient in AndroGel 1.62% is testosterone. Testosterone USP is a white to almost white powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is:
The inactive ingredients in AndroGel 1.62% are: carbopol 980, ethyl alcohol, isopropyl myristate, purified water, and sodium hydroxide.
What are the precautions when taking testosterone gel (AndroGel 1.62)?
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...
Last reviewed on RxList: 11/7/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional AndroGel 1.62 Information
AndroGel 1.62 - User Reviews
AndroGel 1.62 User Reviews
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