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Oxycodone HCI Tablets, USP CII 5 mg

INDICATIONS AND USAGE

Oxycodone Hydrochloride Tablets, USP (CII) are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.

IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

  • Oxycodone tablets are contraindicated:
  • In patients with hypersensitivities to oxycodone.
  • Any situation where opioids are contraindicated
    • In patients who have or are suspected of having paralytic ileus.
    • In patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment).
    • In patients with acute or severe bronchial asthma or hypercarbia.

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.
  • Oxycodone hydrochloride tablets should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression.
  • Oxycodone is a Schedule II controlled substance, and like other opioids used in analgesia, can be abused and is subject to criminal diversion. Oxycodone hydrochloride tablets are intended for oral use only. Abuse of oxycodone hydrochloride tablets poses a risk of overdose and death. The risk is increased with concurrent abuse of alcohol and other substances. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
  • 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.
  • Use of oxycodone hydrochloride tablets is associated with increased potential risks and should be used only with caution in the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); convulsive disorders; CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis.
  • 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 may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.
  • Oxycodone hydrochloride tablets may cause spasm of the sphincter of Oddi. Opioids like oxycodone hydrochloride tablets may cause increases in the serum amylase level.

ADVERSE REACTIONS

  • Severe adverse reactions: respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock.
  • Common adverse reactions include nausea, constipation, vomiting, headache, and pruritus.

USE IN SPECIFIC POPULATIONS

  • Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms.
  • Breast feeding: oxycodone has been detected in breast milk.
  • Pediatrics: safety and effectiveness in pediatric patients have not been established.

Description White/Round Tab
Dosage Strength 5 mg
Compares To Roxicodone™ Percolone™
Identification Code Debossed with "M" in a box on one side, and "0552" with a vertical bisect between the fives on the other
Rating AB

Ordering Information

NDC # Package Size Case Quantity
0406-0552-01 100's 12
0406-0552-62 100 UD (ten 2x5 blister cards) 24

For additional information on Oxycodone HCI Tablets, USP CII 5 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.

Roxicodone is a registered trademark of Xanodyne Pharmaceuticals, Inc. Percolone is a trademark of its respective owner.