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

  INDICATIONS

  • Male Hypogonadotrophic Hypogonadism
  • Delayed Puberty- Male
  • Primary Hypogonadism

  DOSAGE

  • Scrotal form: 6mg/day system applied to the scrotum daily; if scrotal area is inadequate, use a 4mg/day system. The system should be worn for 22-24 hours
  • Scrotal form: If desired results not achieved within 6-8 weeks, consider another form of testosterone for treatment
  • Non-scrotal form: 5mg/day system applied to dry area of the skin on arm, back, upper buttocks.
  • Non-scrotal form: Press system firmly in place with palm of hand for 10 seconds. If system falls off- the same system may be reapplied.
  • Non-scrotal form: However, if system comes off after 12 hrs, it cannot be reapplied; a new system may be applied at the next application time
  • Non-scrotal form: Wear the system for 24 hrs then replace

  PHARMACOKINETICS

  • Apply in the morning; following placement on scrotal skin, serum concentration rises to a maximum at 2 to 4 hours and returns to baseline within 2hrs of removal
  • Serum levels reach a plateau in 3 to 4 weeks
  • Testosterone levels achieved with Testoderm generally are within the low normal range for youner men
  • Scrotal skin is greater than or equal to 5 times more permeable to testosterone than other skin sites
  • Non-scrotal Testoderm will not produce adequate testosterone concentration if applied to non-scrotal skin
  • 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 (rare)
  • Gynecomastia (<3%)
  • Prostate disorders such as prostate cancer, enlargement of the prostate, BPH, elevated PSA (1%)
  • Increased LDL cholesterol and reduced HDL cholesterol
  • Increase in fat-free mass, muscle size, and strength in males
  • Priapism
  • Mild but significant increases in mean RBC, hematocrit, and hemoglobin concentrations
  • Sleep apnea
  • Acne (1-4%)
  • Hair loss
  • Breast pain (1-3%)

  CONTRAINDICATIONS

  • Hypersensitivity to testosterone
  • Males with breast carcinoma
  • Testosterone may cause fetal harm.
  • Do not use in patients with carcinoma of the prostate

  DRUG INTERACTIONS

  • Oral anticoagulants
  • Cyclosporin
  • DHEA (dihydroepiandrosterone)
  • Dong quai (Angelica dahurica)

  FORMS

  • Scrotal Form: Testoderm 4mg/24hr, 6mg/24hr
  • Scrotal Form: Testoderm with Adhesive 6mg/24hr
  • Non-Scrotal Form: Testoderm TTS 5mg/24hr

  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
 
IMPORTANT POINTS/RECOMMENDATIONS
  • 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)
  • Sleep apnea may be potentiated in obese patients or in those with chronic lung diseases
  • For Testoderm TTS - place adhesive side on a clean, dry area of the arm, back, upper buttocks. Do not apply to scrotum.
  • For Testoderm and Testoderm with Adhesive: apply to scrotum; shave scrotal hair for optimal skin contact
  • If system comes off after wearing > 12hrs, it cannot be reapplied. A new system must be applied at the next application time.
  • Serum PSA abd digital rectal exam prior to and during treatment
  • Hemtocrit should be measured prior to treatment as well as every 6 months during treatment.
 
REFERENCES
  1. Hutchison TA & Shahan DR (Eds): ;  Testosterone ;  MICROMEDEX┬« Healthcare Series: MICROMEDEX, Greenwood Village, Colorado (Edition expires 3-2002)

  2. Hebel SK, Kastrup EK (Eds) ;  Testosterone Transdermal Systems ;  Facts and Comparisons, St. Louis, MO (updated 2002)

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