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Oxycodone Hydrochloride Oral Solution

OXYCODONE HYDROCHLORIDE ORAL SOLUTION

Manufacturer: Aurolife Pharma, LLC

Score: 144.0

Quick Summary

Oxycodone Hydrochloride Oral Solution is an opioid agonist used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is available in two concentrations: 5 mg per 5 mL (1 mg/mL) and 100 mg per 5 mL (20 mg/mL). The solution is used for opioid-tolerant patients only and should be initiated at a dose of 5 to 15 mg every 4 to 6 hours as needed for pain. Important safety information includes the risk of addiction, abuse, and misuse, as well as life-threatening respiratory depression, accidental ingestion, and neonatal opioid withdrawal syndrome. The drug is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, known or suspected gastrointestinal obstruction, and hypersensitivity to oxycodone.

Key Clinical Findings and Indications

  • Management of pain severe enough to require an opioid analgesic
  • Alternative treatments are inadequate
  • Opioid-tolerant patients only
  • Available in two concentrations: 5 mg per 5 mL (1 mg/mL) and 100 mg per 5 mL (20 mg/mL)

Important Safety Information

Warning

Risk of addiction, abuse, and misuse, as well as life-threatening respiratory depression, accidental ingestion, and neonatal opioid withdrawal syndrome

Contraindications

  • Significant respiratory depression
  • Acute or severe bronchial asthma
  • Known or suspected gastrointestinal obstruction
  • Hypersensitivity to oxycodone

Adverse Reactions

  • Nausea
  • Constipation
  • Vomiting
  • Headache
  • Pruritus
  • Insomnia
  • Dizziness
  • Asthenia
  • Somnolence

Dosing Recommendations

General Guidance

Titrate the dose based on individual patient response, with a maximum dose of 100 mg per 5 mL (20 mg/mL) for opioid-tolerant patients

Pain management

Adult Dose

5 to 15 mg every 4 to 6 hours as needed

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Prolonged use may cause neonatal opioid withdrawal syndrome
  • Use during pregnancy only if potential benefits outweigh risks

Nursing Mothers

  • Oxycodone is excreted in breast milk
  • Use with caution and monitor infant for signs of sedation and respiratory depression

Pediatric Use

  • Safety and effectiveness not established in pediatric patients below 18 years of age

Geriatric Use

  • Use with caution due to increased sensitivity to oxycodone
  • Monitor for signs of central nervous system and respiratory depression

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