ROXICODONE is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use:

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve ROXICODONE for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products):

• Have not been tolerated or are not expected to be tolerated,

• Have not provided adequate analgesia or are not expected to provide adequate analgesia.

ROXICODONE should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

• ROXICODONE should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks.

• Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of ROXICODONE for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.

• Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available.

• There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying case and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse.

• Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with ROXICODONE. Consider this risk when selecting an initial dose and when making dose adjustments.

• Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with ROXICODONE. Consider prescribing naloxone based on the patient’s risk factors for overdose.

• Initiate treatment with ROXICODONE in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of ROXICODONE.

• Do not abruptly discontinue ROXICODONE in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.

Immediate-release tablets: 15 mg, 30 mg

• Significant respiratory depression

• Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment

• Known or suspected gastrointestinal obstruction, including paralytic ileus

• Hypersensitivity to oxycodone

• Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation.

• Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Regularly evaluate closely, particularly during initiation and titration.

• Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

• Severe Hypotension: Regularly evaluate during dosage initiation and titration. Avoid use of ROXICODONE in patients with circulatory shock.

• Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of ROXICODONE in patients with impaired consciousness or coma.

Most common adverse reactions (≥3%) were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt at 1-800-778-7898 or FDA at 1-800-FDA-1088or www.fda.gov/medwatch.

• Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue ROXICODONE if serotonin syndrome is suspected.

• Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with ROXICODONE because they may reduce analgesic effect of ROXICODONE or precipitate withdrawal symptoms.

• Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of morphine. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI.

• Pregnancy: May cause fetal harm.