Fentanyl

FDA label

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Titration Titrate to an effective dose over successive breakthrough episodes.

Renal Administer with caution in renal dysfunction.

Hepatic Administer with caution in hepatic dysfunction.

No more than 2 doses per breakthrough episode; wait ≥2 hours before treating another episode; limit to ≤4 episodes/day.

Instructions

• Place on the floor of the mouth directly under the tongue and allow to dissolve completely.
• Patients must require and use around-the-clock opioids.
• Do not convert mcg-per-mcg from other fentanyl products; start all patients at 100 mcg.
• Do not substitute for any other fentanyl product.

Contraindications

• Opioid non-tolerant patients
• Acute or postoperative pain, including headache/migraine, dental pain, or ER use

Cautions

• MAOIs due to risk of serotonin syndrome
• Respiratory and CNS depression (can be fatal even at recommended doses)
• Do not convert mcg-per-mcg from other fentanyl products
• Contains a dose of fentanyl fatal to a child — proper storage/disposal
• Increased depressant effects with other CNS depressants and CYP3A4 inhibitors
• Caution in COPD/conditions predisposing to hypoventilation and CO2 retention
• Abuse potential (Schedule II)

Adverse reactions

• Nausea
• Somnolence
• Headache
• Constipation

Pregnancy Category C; chronic use associated with neonatal abstinence syndrome; use only if benefit justifies risk.

Lactation Fentanyl is excreted in human milk; do not use in nursing women (risk of sedation/respiratory depression).