Replacement therapy for male conditions associated with a deficiency or absence of endogenous testosterone.

Testosterone is an endogenous androgen, which are responsible for normal growth and development of male sex organs.

Testosterone penetrates the stratum corneum within 2 minutes and diffuses into the epidermis, establishing an intradermal reservoir then absorbs into systemic circulation. Approximately 10% of the applied testosterone dose is absorbed during a 24-hour period. Normal range testosterone levels were seen within 4 hours after initial application and steady-state concentrations are reached on day 2 or 3. Serum testosterone levels return to pretreatment levels by the 5th day after last multiple dose application. The major active metabolites of testosterone are estradiol and dihydrotestosterone (DHT).

Avoid in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Androgel is not indicated for use in women. Androgel should not be used in patients with known hypersensitivity to any of its ingredients, including testosterone USP that is chemically synthesized from soy.

X

avoid

Application site reaction (4%), breast pain (1-3%), prostate disorder (18.8%)

initial, 5 g (delivering 50 mg) applied once daily (preferably in the morning) to clean, dry, intact skin of the shoulders and upper arms and/or abdomen; do NOT apply to genitals; may increase dose to 7.5-10 g.