Misuse and abuse may lead to overdose and death. Assess risk before subscribing and regularly monitor for signs of these behaviors and conditions. Serious and potentially fatal respiratory depression may occur. Monitor for respiratory depression, particularly when initiating or increasing dosage. Accidental ingestion of one dose or more can lead to fatal overdose, especially in children. Prolonged use during pregnancy can lead to potentially life-threatening neonatal opioid withdrawal syndrome. Initiation of CYP3A4 inhibitors or discontinuation of CYP3A4 inducers may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation .

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