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Butorphanol Tartrate

BUTORPHANOL TARTRATE

Manufacturer: Hikma Pharmaceuticals USA Inc.

Score: 147.0

Quick Summary

Butorphanol Tartrate Nasal Spray is an opioid analgesic used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is a partial opioid agonist at the mu opioid receptor and a full agonist at the kappa opioid receptor. The drug has several key clinical findings and indications, including its use in postoperative pain, migraine headache pain, and pain of musculoskeletal origin. Important safety information includes the risk of addiction, abuse, and misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome. The main dosing recommendations include an initial dose of 1 mg, with titration to achieve adequate analgesia and minimize adverse reactions. Special population considerations include use in pregnancy, nursing mothers, pediatric patients, and geriatric patients, with caution advised due to increased sensitivity and potential for adverse reactions.

Key Clinical Findings and Indications

  • Postoperative pain
  • Migraine headache pain
  • Pain of musculoskeletal origin
  • Analgesic efficacy comparable to meperidine and methadone

Important Safety Information

Warning

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

Contraindications

  • Significant respiratory depression
  • Acute or severe bronchial asthma
  • Known or suspected gastrointestinal obstruction
  • Hypersensitivity to butorphanol tartrate or any component of the formulation

Adverse Reactions

  • Somnolence
  • Dizziness
  • Nausea and/or vomiting
  • Nasal congestion
  • Insomnia

Dosing Recommendations

General Guidance

Titrate dose based on individual patient response, with caution advised in elderly patients and those with hepatic or renal impairment

Pain

Adult Dose

1 mg (1 spray in one nostril) every 3 to 4 hours as needed

Pediatric Dose

Not recommended for use in patients below 18 years of age

Special Population Considerations

Pregnancy

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

Nursing Mothers

  • Butorphanol detected in milk
  • Monitor infant for excess sedation and respiratory depression

Pediatric Use

  • Not recommended for use in patients below 18 years of age
  • Safety and efficacy not established

Geriatric Use

  • Increased sensitivity to butorphanol
  • Caution advised due to potential for adverse reactions
  • Initial dose of 1 mg, with 90 to 120 minutes between doses