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    IMPORTANT SAFETY INFORMATION
    WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

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    To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to • complete a REMS-compliant education program, • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and • consider other tools to improve patient, household, and community safety.

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    Serious, life-threatening, or fatal respiratory depression may occur with use of ROXICODONE. Monitor for respiratory depression, especially during initiation of ROXICODONE or following a dose increase.

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    Accidental ingestion of ROXICODONE, especially by children, can result in a fatal overdose of ROXICODONE.

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    Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
    Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

    Reserve concomitant prescribing of ROXICODONE and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
    Limit dosages and durations to the minimum required.
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