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  Testosterone (Androderm)
 
Author: Donna Karasic, PharmD Last modified: March 31, 2002
 

  INDICATIONS

  • Male Hypogonadotrophic Hypogonadism
  • Delayed Puberty- Male
  • Primary Hypogonadism
  • Metastatic Breast Cancer- Female

  DOSAGE

  • 5 mg/day system applied to a clean, dry area of the back, abdomen, upper arms or thighs every 24 hours
  • Based upon serum concentrations, dose increase or decrease with a 2.5mg patch

  PHARMACOKINETICS

  • Following application to non-scrotal skin, testosterone is continuously absorbed during the 24 hr period
  • Daily application at 10pm results in serum concentration that mimics the normal circadian variation
  • Maximal concentrations occur in early morning hours; minimal concentration in the evening
  • Variable half-life of testosterone, from 10 to 100 minutes
  • Extensively metabolized by the liver
  • Testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone
  • Renal excretion is 90%; 6% excreted in the feces

  ADVERSE EFFECTS

  • Irritation at application site (<6%)
  • Edema
  • Hypertension (1%)
  • Headache (1-6%)
  • Pruritis (2-37%)
  • Anxiety (<1%), amnesia (<1%), depression, headache (1-6%), hostility (<1%)
  • Gynecomastia (1-5%)
  • Hypercalcemia, hyperglycemia, hypokalemia (<1%)
  • Prostate disorders such as prostate cancer, enlargement of the prostate, BPH, elevated PSA (<5%)
  • Increased LDL cholesterol and severely reduced HDL cholesterol
  • Increase in fat-free mass, muscle size, and strength in males.
  • Priapism
  • Hepatotoxicity
  • Hepatocellular carcinoma, hepatic adenomas, and peliosis hepatitis
  • Myocardial infarct
  • Mild but significant increases in mean WBC, RBC, hematocrit, and hemoglobin concentrations
  • Acne (1-4%)
  • Hair loss
  • Breast pain (1-3%)

  CONTRAINDICATIONS

  • Hypersensitivity to testosterone
  • Males with breast carcinoma
  • Testosterone may cause fetal harm.
  • The application site(s) should be covered in order to prevent transfer of testosterone from males to females upon skin-to-skin contact.
  • Do not use in patients with extensive cardiac, hepatic, or renal disease
  • Do not use in patients with carcinoma of the prostate

  DRUG INTERACTIONS

  • Oral anticoagulants
  • Cyclosporin
  • DHEA (dihydroepiandrosterone)
  • Dong quai (Angelica dahurica)
  • Corticosteroids, ACTH
  • Insulin

  FORMS

  • 2.5mg/24hr and 5mg/24hr transdermal systems

  MECHANISM OF ACTION

  • Testosterone is an endogenous androgen and are responsible for normal growth and development of male sex organs
  • Testosterone is involved in the growth, maturation of prostate, seminal vesicles, penis, scrotum, development of male hair distribution,
  • also laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution
  • Testosterone increases protein anabolism and decrease protein catabolism
 
IMPORTANT POINTS/RECOMMENDATIONS
  • Apply adhesive side of system to clean, dry area of skin; avoid bony prominences
  • Rotate sites of application, with an interval of 7 days between applications to the same site
  • Use with caution in geriatric patients (increased risk of prostatic hypertrophy and prostatic carcinoma)
  • Use with caution in patients with BPH (urethral obstruction may occur)
  • Use with caution in patients with edema with or without congestive heart failure
  • Use with caution in patients with a history of myocardial infarction or coronary artery disease
  • Sleep apnea may be potentiated in obese patients or in those with chronic lung diseases
 
REFERENCES
  1. Hutchinson TA & Shahan DR (Eds) ;  Testosterone ;  MICROMEDEX Healthcare Series; MICROMEDEX, Greenwood Village, Colorado (edition expires 3-2002)

Copyright © 2002 The Johns Hopkins University School of Medicine. All rights reserved.