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Fentanyl system

FENTANYL

Manufacturer: ALVOGEN

Score: 144.0

Quick Summary

Fentanyl transdermal system is used for the management of severe and persistent pain that requires an extended treatment with a daily opioid analgesic and for which alternative treatment options are inadequate. The system is contraindicated in patients who are not opioid-tolerant, and its use is associated with serious risks, including addiction, abuse, and misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome. The recommended dosage is individualized and based on the patient's previous opioid usage, with careful titration to minimize adverse effects.

Key Clinical Findings and Indications

  • Management of severe and persistent pain
  • Opioid-tolerant patients only
  • Extended-release/long-acting opioid formulation

Important Safety Information

Warning

Addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome

Contraindications

  • Not opioid-tolerant
  • Acute or intermittent pain
  • Post-operative pain
  • Mild pain
  • Significant respiratory depression
  • Acute or severe bronchial asthma
  • Known or suspected gastrointestinal obstruction
  • Hypersensitivity to fentanyl

Adverse Reactions

  • Nausea
  • Vomiting
  • Somnolence
  • Dizziness
  • Insomnia
  • Constipation
  • Hyperhidrosis
  • Fatigue
  • Feeling cold
  • Anorexia
  • Headache
  • Diarrhea

Dosing Recommendations

General Guidance

Titrate carefully to minimize adverse effects, with dose increments no more frequently than 3 days

Severe and persistent pain

Adult Dose

Individualized based on previous opioid usage

Pediatric Dose

Not recommended for pediatric patients under 2 years of age

Special Population Considerations

Pregnancy

  • Use during pregnancy only if potential benefit justifies potential risk to fetus
  • Neonatal opioid withdrawal syndrome possible

Nursing Mothers

  • Use with caution, as fentanyl is excreted in breast milk

Pediatric Use

  • Not recommended for pediatric patients under 2 years of age
  • Use with caution in pediatric patients 2-18 years of age

Geriatric Use

  • Use with caution, as elderly patients may be more sensitive to fentanyl
  • Dose selection should be cautious, and renal function should be monitored

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