Fentanyl Pharmacokinetic Characteristics Following Duragesic Application

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Fentanyl Pharmacokinetic Characteristics
Following Duragesic Application

• Pediatric Subcommittee of the
• Anti-infective Drugs Advisory Committee Meeting
• June 9th, 2004
• David J. Lee, Ph.D.
• Clinical Pharmacology Reviewer
• FDA

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Duragesic Pharmacokinetics

• Following DURAGESIC Initial application
• Skin under the transdermal system absorbs
  fentanyl, and a depot of fentanyl concentrates in
  the upper skin layers. Fentanyl then becomes
  available to the systemic circulation.
• Peak serum concentrations of fentanyl generally
  occurred between 24 and 72 hours.

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Duragesic Pharmacokinetics

• After Duragesic removal
• Serum fentanyl concentrations decline gradually,
  falling about 50 in approximately 17 (range
  13-22) hours.
• Continued absorption of fentanyl from the skin
  accounts for a slower disappearance of the drug
  from the serum than is seen after an IV infusion,
  where the apparent half-life is approximately 7
  (range 3-12) hours.

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Potential Implications

• After the initial application of Duragesic full
  drug benefit may not be seen immediately.
• After removal of Duragesic, substantial drug
  effect may still be felt for a significant period
  of time.

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Back-up Slides
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Duragesic Patch fentanyl systemic levels
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Duragesic Patch fentanyl systemic levels
Adult 50 ?g/mL
Adult
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Duragesic Patch fentanyl systemic levels
Adult 50 ?g/mL Pediatric 25 ?g/mL
Pediatric
Adult
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Duragesic Patch fentanyl systemic levels
Adult 50 ?g/mL Pediatric 25 ?g/mL
Pediatric
Adult
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