Important Safety Information Prescribing Information For Patients
  1. AndroGel [package insert]. Marietta, GA: Unimed Pharmaceuticals, Inc; 2007.

  2. Swerdloff RS, Wang C, Cunningham G, et al; and Testosterone Gel Study Group. Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J Clin Endocrinol Metab. 2000;85(12):4500-4510.

  3. Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006;60(7):762-769.

  4. IMS Health, June 2000, December 2005.

  5. Rhoden EL, Ribeiro EP, Teloken C, Souto CAV. Diabetes mellitus is associated with subnormal serum levels of free testosterone in men. BJU Int. 2005;96:867-870.

  6. Dhindsa S, Prabhakar S, Sethi M, Bandyopadhyay A, Chaudhuri A, Dandona P. Frequent occurrence of hypogonadotropic hypogonadism in type 2 diabetes. J Clin Endocrinol Metab. 2004;89(11):5462-5468.

  7. Centers for Disease Control and Prevention (CDC). Prevalence of overweight and obesity among adults with diagnosed diabetes—United States, 1988-1994 and 1999-2002. MMWR Morb Mortal Wkly Rep. 2004;53(45):1066-1068.

  8. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in adult men with androgen deficiency syndromes: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2006;91(6):1995-2010.

  9. Dobs AS, Dempsey MA, Ladenson PW, Polk BF. Endocrine disorders in men infected with human immunodeficiency virus. Am J Med. 1988;84:611-616.

  10. Dobs AS. Androgen therapy in AIDS wasting. Baillieres Clin Endicrinol Metab. 1998;12:379-390.

  11. Data on file, Solvay Pharmaceuticals, Inc. Marietta, GA.

  12. Kapoor D, Aldred H, Clark S, Channer KS, Jones TH. Clinical and biochemical assessment of hypogonadism in men with type 2 diabetes: correlations with bioavailable testosterone and visceral adiposity. Diabetes Care. 2007;30(4):911-917.

  13. Vermeulen A, Kaufman JM, Giagulli VA. Influence of some biological indexes on sex hormone-binding globulin and androgen levels in aging or obese males. J Clin Endocrinol Metab. 1996;81:1821-1826.

  14. Wang C, Swerdloff RS, Iranmanesh A, et al; and Testosterone Gel Study Group. Effects of transdermal testosterone gel on bone turnover markers and bone mineral density in hypogonadal men. Clin Endocrinol. 2001;54:739-750.

  15. Wang C, Swerdloff RS, Iranmanesh A, et al; and Testosterone Gel Study Group. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. J Clin Endocrinol Metab. 2000;85(8):2839-2853.

  16. Wang C, Cunningham G, Dobs A, et al. Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men. J Clin Endocrinol Metab. 2004;89:2085-2098.

  17. Shabsigh R. Testosterone therapy in erectile dysfunction and hypogonadism. J Sex Med. 2005;2:785-792

AndroGel is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. AndroGel is not indicated for use in women.

Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.

The most frequent adverse events reported by ≥5% of patients associated with the consistent use of AndroGel included abnormal lab test, acne, prostate disorder, and application site reaction.
This information is intended for residents of the United States.
For international product information please visit us at http://www.solvay.com.
© 2007 Solvay Pharmaceuticals, Inc.
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