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Androderm, Testosterone Transdermal System

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Confirming the Diagnosis

To confirm the diagnosis of testosterone deficiency, two blood tests are commonly utilized, "total testosterone" and "free testosterone". The normative ranges for total and free testosterone levels in healthy young men vary among laboratories and assays. In some laboratories, the lower limit of the normal range for total testosterone level in healthy young men is 300ng/dl (10.4nmol/L). In some reference laboratories the lower limit of normal range for serum free testosterone level, measured by the equilibrium dialysis method is 50 pg/ml (0.17 nmol/L). The clinician should use the lower limit of normal range for healthy young men established in their reference laboratory.[6]

 

Safety Information

In geriatric patients, treatment with testosterone may increase the risk of developing benign prostatic hyperplasia and may promote the growth of existing prostate cancer. In clinical studies of 122 patients treated with Androderm, skin irritation from the patch was the most common adverse event (pruritus at application site [37%], burn-like blister reaction under system [12%], and erythema at application site [7%]). During such studies a total of 9% of patients discontinued Androderm treatment due either to chronic skin irritation or allergic contact dermatitis associated with the patch. Applying a small amount of 0.1% triamcinolone acetonide cream to the skin prior to patch application has been shown to reduce the incidence and severity of skin irritation. Androderm should not be applied over bone prominences or over areas subject to prolonged pressure. Androderm must not be used in women. Patients should remove Androderm before undergoing an MRI due to risk of skin burns.

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

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+ 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.
[6] Bhasin S et al., Testosterone Therapy in Adult men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline, J Clin Endocrinol & Metab, June 2006,91(6)1999:1995-2010.
Þ Includes free, albumin-bound, and SHBG-bound testosterone.
‡ As determined by equilibrium dialysis.
* Clinical significance is unknown.

 

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