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Oxycodone and Acetaminophen

OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN

Manufacturer: Mayne Pharma Inc.

Score: 147.0

Quick Summary

Oxycodone Hydrochloride and Acetaminophen is a combination medication used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It contains oxycodone, a full opioid agonist, and acetaminophen, a non-opiate analgesic. The medication is available in a liquid form for oral administration, with each 5 mL containing 10 mg of oxycodone hydrochloride and 300 mg of acetaminophen. It is essential to use the medication with caution due to the risks of addiction, abuse, and misuse, as well as potential side effects such as respiratory depression, constipation, and liver damage.

Key Clinical Findings and Indications

  • Management of pain severe enough to require an opioid analgesic
  • Alternative treatments are inadequate
  • Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor
  • Acetaminophen is a non-opiate analgesic and antipyretic

Important Safety Information

Warning

Risk of accidental overdose and death due to medication errors, addiction, abuse, and misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome

Contraindications

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
  • Hypersensitivity to oxycodone, acetaminophen, or any other component of the product

Adverse Reactions

  • Respiratory depression
  • Constipation
  • Nausea
  • Vomiting
  • Dizziness
  • Drowsiness
  • Hepatotoxicity

Dosing Recommendations

General Guidance

Titrate the dosage slowly and monitor closely for signs of central nervous system and respiratory depression

Pain management

Adult Dose

5 mL (one teaspoonful) every 6 hours as needed, with a maximum daily dose of 6 teaspoonfuls or 30 mL

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome
  • Use with caution and only if the potential benefits outweigh the possible hazards

Nursing Mothers

  • Ordinarily, nursing should not be undertaken while a patient is receiving Oxycodone Hydrochloride and Acetaminophen
  • Oxycodone is excreted in breast milk in low concentrations, and there have been rare reports of somnolence and lethargy in babies of nursing mothers

Pediatric Use

  • Safety and effectiveness have not been established in pediatric patients

Geriatric Use

  • Elderly patients may have increased sensitivity to Oxycodone Hydrochloride and Acetaminophen
  • Use with caution and start with a low dose, titrating slowly and monitoring closely for signs of central nervous system and respiratory depression

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