Testosterone Gel, 1%

Warning

Secondary exposure to testosterone can occur, particularly for children and women, resulting in virilization and other adverse effects

Contraindications

• Carcinoma of the breast or known or suspected carcinoma of the prostate
• Pregnancy

Adverse Reactions

• Acne
• Application site reactions
• Prostate disorders
• Gynecomastia
• Testis disorder

General Guidance

Dose adjustments should be based on serum testosterone concentrations, with a goal of achieving normal testosterone levels

Pregnancy

• Testosterone Gel, 1% is contraindicated in pregnant women
• Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman

Nursing Mothers

• Testosterone Gel, 1% may cause virilization of female infants if exposed to the drug through breast milk

Pediatric Use

• The safety and efficacy of Testosterone Gel, 1% in pediatric patients less than 18 years old has not been established
• Improper use may result in acceleration of bone age and premature closure of epiphyses

Geriatric Use

• There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing Testosterone Gel, 1% to determine whether efficacy in those over 65 years of age differs from younger subjects
• Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH