IMPORTANT RISK INFORMATION
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
- Oxycodone and acetaminophen tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product.
- Oxycodone is contraindicated in any situation where opioids are contraindicated including:
- patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment).
- patients with acute or severe bronchial asthma or hypercarbia.
- in the setting of suspected or known paralytic ileus.
WARNINGS AND PRECAUTIONS
- Respiratory depression is the chief hazard from all opioid agonist preparations. In some patients, usual therapeutic doses of opioids may cause respiratory depression. Patients with pulmonary conditions and pre-existing respiratory depression are at the highest risk.
- There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.
- Oxycodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of this drug.
- The adverse effects of narcotics may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may obscure the clinical course of patients with head injuries or acute abdominal conditions.
- Oxycodone may cause severe hypotension in individuals whose ability to maintain blood pressure has been compromised.
- Opioid analgesics should be used with caution when combined with CNS depressant drugs.
- Oxycodone and acetaminophen tablets should be given with caution to patients with CNS depression, elderly or debilitated patients, patients with severe impairment of hepatic, pulmonary, or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, urethral stricture, acute alcoholism, delirium tremens, kyphoscoliosis with respiratory depression, myxedema, and toxic psychosis.
- Agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in patients receiving a course of therapy with oxycodone.
- Oxycodone may cause spasm of the Sphincter of Oddi. Opioids like oxycodone may cause increases in the serum amylase level.
- Serious adverse reactions may include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock.
- Common adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea and vomiting, euphoria, dysphoria, constipation, and pruritus.
USE IN SPECIFIC POPULATIONS
- Use of narcotics during pregnancy may produce physical dependence in the neonate.
- Breast feeding: oxycodone and acetaminophen are excreted in breast milk in low concentrations.
- Pediatrics: Safety and effectiveness in pediatric patients have not been established.
|Dosage Strength||5 mg/325 mg|
|Identification Code||Scored on one side, debossed 512 on the other side|
|NDC #||Package Size||Case Quantity|
|0406-0512-62||100 UD (ten 2×5 blister cards)||24|