Oxycodone 80mg ER Tablets

• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome or severe respiratory depression)
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice) in patients not already tolerant to high doses of oxycodone (risk of increased oxycodone plasma concentrations and potentially fatal respiratory depression)

• Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, fentanyl): Risk of serotonin syndrome.
• Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine): May reduce analgesic effect and/or precipitate withdrawal symptoms.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): Significant increase in oxycodone plasma concentrations, leading to increased opioid effects and potential for fatal respiratory depression.
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease oxycodone plasma concentrations, leading to reduced efficacy and potential for withdrawal symptoms.
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May decrease formation of oxymorphone, potentially reducing analgesic effect in some patients.

• Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and/or severe constipation.
• Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
• Antihypertensives: May cause additive hypotensive effects.

• Not available

• Respiratory depression (slow, shallow breathing, blue lips/fingernails)
• Excessive sedation/drowsiness
• Dizziness
• Nausea and vomiting
• Constipation
• Pruritus (itching)
• Urinary retention
• Confusion
• Miosis (pinpoint pupils)
• Signs of opioid withdrawal (e.g., restlessness, yawning, lacrimation, rhinorrhea, piloerection, sweating, muscle aches, abdominal cramps, diarrhea, nausea, vomiting) if dose is rapidly reduced or discontinued.

Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS) in the newborn, which may be life-threatening if not recognized and treated. Advise pregnant patients of the risk of NOWS and ensure appropriate treatment will be available. Use only if the potential benefit justifies the potential risk to the fetus.

Oxycodone is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and efficacy have not been established in pediatric patients under 18 years of age. Not recommended for use in this population.

Elderly patients may be more sensitive to the analgesic and adverse effects of oxycodone, particularly respiratory depression. Start with lower doses and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation.

• Oxycodone 80mg ER is a high dose and is indicated ONLY for opioid-tolerant patients with severe, chronic pain requiring continuous, around-the-clock opioid analgesia.
• The extended-release formulation must be swallowed whole. Crushing, chewing, or dissolving the tablet can lead to rapid release and absorption of a potentially fatal dose of oxycodone.
• Due to the high risk of addiction, abuse, and misuse, Oxycodone ER is subject to a REMS program. Prescribers should be familiar with and adhere to REMS requirements.
• Concomitant use with benzodiazepines or other CNS depressants significantly increases the risk of respiratory depression, profound sedation, coma, and death. Avoid concomitant use if possible; if necessary, use the lowest effective doses and shortest durations, and monitor closely.
• Naloxone should be considered for co-prescription, especially for patients at increased risk of overdose (e.g., concomitant CNS depressant use, history of substance use disorder).
• Patients should be educated on the safe storage and disposal of this medication to prevent accidental ingestion, especially by children.

• Other strong opioid analgesics (e.g., hydromorphone, fentanyl, methadone)
• Non-opioid analgesics for chronic pain (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, duloxetine, tricyclic antidepressants)
• Interventional pain management techniques (e.g., nerve blocks, spinal cord stimulation)
• Physical therapy, occupational therapy, psychological therapies (e.g., CBT)