FENTANYL

Manufacturer: Mylan Pharmaceuticals Inc.

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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