Classes
DEA Class; Rx
Common Brand Names; Percocet, Primlev, Roxicet, Endocet, Xartemis XR
- Analgesics, Opioid Combos
Description
Combination product to treat moderate to severe pain. Acetaminophen is a non-salicylate analgesic; oxycodone is an oral semisynthetic opiate agonist. The combination produces additive analgesia as compared to either agent alone.
Indications
Contraindications
Hypersensitivity
Suspected or known gastrointestinal obstruction, including paralytic ileus
Acute or severe bronchial asthma or hypercarbia
Significant respiratory depression (bronchial asthma, hypercarbia, COPD)
Adverse Effects
Lightheadedness
Dizziness
Drowsiness or sedation
Nausea and vomiting
Euphoria
Dysphoria
Constipation
Pruritus
Skin and urticarial eruptions
Fatal hepatic necrosis (rare; associated with high/chronic acetaminophen use)
Renal tubular necrosis
Warnings
Therapy may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (eg, phenothiazines or general anesthetics); monitor patients for signs of hypotension after initiating or titrating dosage; in patients with circulatory shock, therapy may cause vasodilation that can further reduce cardiac output and blood pressure; avoid therapy in patients with circulatory shock
In patients who may be susceptible to intracranial effects of CO2 retention (eg, those with evidence of increased intracranial pressure or brain tumors), therapy may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure; monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy; opioids may obscure clinical course in a patient with a head injury; avoid the use in patients with impaired consciousness or coma
Contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; may cause spasm of sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms
Pregnancy and Lactation
Pregnancy
Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome; there are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage; published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects
Lactation
Drug is present in breast milk; published lactation studies report variable concentrations of drug in breast milk with administration of immediate-release formulation to nursing mothers in early postpartum period
The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy; capsules and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Monitor infants exposed to drug through breast milk for excess sedation and respiratory depression; withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast- feeding is stopped
Maximum Dosage
Immediate-release formulations: Acetaminophen 4 g/day PO; the maximum dose of the acetaminophen; oxycodone combination is limited by the total daily limit of acetaminophen.
Extended-release tablets: 4 tablets/day PO. Total daily dose of acetaminophen from all products should not exceed 4 g/day PO.
Immediate-release formulations: Acetaminophen 4 g/day PO; the maximum dose of the acetaminophen; oxycodone combination is limited by the total daily limit of acetaminophen.
Extended-release tablets: 4 tablets/day PO. Total daily dose of acetaminophen from all products should not exceed 4 g/day PO.
Immediate-release formulations: Safety and efficacy have not been established. Doses containing up to acetaminophen 4 g/day PO have been used. The maximum dose of the acetaminophen; oxycodone combination is limited by the total daily limit of acetaminophen.
Extended-release tablets: Safety and efficacy have not been established.
Immediate-release formulations: Safety and efficacy have not been established. Doses up to acetaminophen 75 mg/kg/day PO or 4 g/day PO, whichever is less, have been used. The maximum dose of the acetaminophen; oxycodone combination is limited by the total daily limit of acetaminophen.
Extended-release tablets: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established