Androderm : HCP : What is Androderm?

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

In clinical studies, Androderm® restored morning testosterone levels to within the normal range in 92% of patients, producing significant improvements in fatigue, mood, and sexual function.[1]

Two dosing strengths are available — 2.5 mg and 5 mg

ANDRODERM 2.5 mg
contains 12.2 mg of testosterone for delivery of 2.5 mg of testosterone per day.

ANDRODERM 5 mg
contains 24.3 mg of testosterone for delivery of 5 mg of testosterone per day.

Safety Information

If you are over 55 years of age, treatment with androgens (such as testosterone) may increase the risk of benign enlargement of the prostate and may promote the growth of existing cancer of the prostate. While using Androderm, some patients may experience skin irritation at the application site. To reduce the risk of such irritation, the patch should not be applied to the same place more than once a week. If irritation occurs and persists in spite of rotating the patch, it may be ameliorated by applying 0.1% triamcinolone acetonide cream. Androderm must not be used by women. Androderm should not be used by men who have breast cancer or by men who are suspected to have cancer of the prostate. Also, Androderm should not be used by men who are hypersensitive to any of the patch components. Adverse events reported by > 5% of patients in clinical trials of Androderm (n=122): pruritus at application site, 37%; burn-like blister reaction under system, 12%; erythema at application site, 7%; vesicles at application site, 6%; prostate abnormalities, 5%. In geriatric patients, treatment with testosterone may increase the risk of developing benign prostatic hyperplasia and may promote the growth of existing prostate cancer. Androderm should not be applied over bony prominences or over areas subject to prolonged pressure. Androderm must not be used in women.

Please see Prescribing Information.

References


	[1] Androderm® Physician Prescribing Information [2] Androderm® Patient Prescribing Information [3] Petak SM. ACCE Medical Guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients-2002 update. Endocr Pract 2002;8: 439-459. [4] Meikle AW, Arver S, Dobs AS, et al. Pharmacokinetics and Metabolism of a Permeation-Enhanced Testosterone Transdermal System in Hypogonadal Men: Influence of Application Site - A Clinical Research Center Study. J Clin Endocrinol Metab1996;81:1832-1840. [5] Kaufman JM, Vermeulen A. Declining gonadal function in elderly men. Bailiere's Clin Endocrinol Metab 1997;11:289-309. Þ Includes free, albumin-bound, and SHBG-bound testosterone. ‡ As determined by equilibrium dialysis. * Clinical significance is unknown.