Oxycodone and Acetaminophen

OXYCODONE AND ACETAMINOPHEN

Manufacturer: Lannett Company, Inc.

Score: 147.0

Quick Summary

Oxycodone 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. The medication contains oxycodone, a full opioid agonist, and acetaminophen, a non-opiate, non-salicylate analgesic and antipyretic. Oxycodone and Acetaminophen tablets are indicated for the relief of moderate to severe pain. However, the use of this medication is associated with several important safety concerns, including the risk of addiction, abuse, and misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, and hepatotoxicity. The medication should be used with caution in certain populations, including the elderly, pregnant women, nursing mothers, and pediatric patients.

Key Clinical Findings and Indications

Management of pain severe enough to require an opioid analgesic
Moderate to severe pain relief
Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor
Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic

Important Safety Information

Warning

Addiction, Abuse, and Misuse; Risk Evaluation and Mitigation Strategy (REMS); Life-Threatening Respiratory Depression; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome, Cytochrome P450 3A4 Interaction; Hepatotoxicity, and Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants

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
Apnea
Respiratory arrest
Circulatory depression
Hypotension
Shock
Lightheadedness
Dizziness
Drowsiness or sedation
Nausea
Vomiting

Dosing Recommendations

General Guidance

The dosage of oxycodone and acetaminophen tablets should be adjusted according to the severity of the pain and the response of the patient. The total daily dose of acetaminophen should not exceed 4 grams.

Moderate to severe pain

Adult Dose

One tablet every 6 hours as needed for pain

Pediatric Dose

Safety and effectiveness in pediatric patients have not been established

Special Population Considerations

Pregnancy

Prolonged use of opioid analgesics during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth
Oxycodone and acetaminophen tablets should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards

Nursing Mothers

Ordinarily, nursing should not be undertaken while a patient is receiving oxycodone and acetaminophen tablets because of the possibility of sedation and/or respiratory depression in the infant
Oxycodone is excreted in breast milk in low concentrations, and there have been rare reports of somnolence and lethargy in babies of nursing mothers taking an oxycodone/acetaminophen product

Pediatric Use

Safety and effectiveness of oxycodone and acetaminophen tablets in pediatric patients have not been established

Geriatric Use

Elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone and acetaminophen tablets
In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range