Oxycodone / Acetaminophen · oral tablet
Analgesics
Approved uses
Acute pain severe enough to require an opioid
1 to 2 tablets of the 2.5 mg/325 mg strength every 6 hours as needed, at the lowest dose that gives adequate analgesia
Stronger than codeine and correspondingly harder to justify for surface pain such as an abrasion
Contraindications
PERCOCET is contraindicated in patients with: 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 (e.g., anaphylaxis)
Oxycodone and acetaminophen tablets, 2.5 mg/325 mg and higher strengths.
Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown.
Warnings & Precautions
- Addiction, abuse and misuse can occur even at recommended doses and can lead to overdose and death.
- Life-threatening respiratory depression may occur, most often early in therapy or after a dose increase.
- Accidental ingestion, especially by a child, can be fatal.
- Acetaminophen has been associated with acute liver failure, at times fatal, usually at doses above 4,000 mg per day and often from more than one product.
- Concomitant use with benzodiazepines or other CNS depressants may cause profound sedation, respiratory depression, coma and death.
- Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome.
Common Side Effects
The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting.
Pregnancy: Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.
Lactation: Oxycodone is present in human milk and may cause sedation and respiratory depression in the infant.
Safety and effectiveness of PERCOCET in pediatric patients have not been established.