ANDROGEL SUMMARY
AndroGel®
(testosterone gel) 1%
AndroGel® (testosterone gel) is a clear, colorless hydroalcoholic gel containing 1% testosterone. AndroGel® provides continuous transdermal delivery of testosterone, the primary circulating endogenous androgen, for 24 hours following a single application to intact, clean, dry skin of the shoulders, upper arms and/or abdomen.
AndroGel® is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
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Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range.
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Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.
AndroGel® has not been clinically evaluated in males under 18 years of age.
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