Opana ER (Oral)

Addiction, Abuse, and MisuseOxymorphone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing oxymorphone, and monitor all patients regularly for the development of these behaviors and conditions Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)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 .Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of oxymorphone. Monitor for respiratory depression, especially during initiation of oxymorphone or following a dose increase Instruct patients to swallow oxymorphone extended-release (ER) tablets whole; crushing, chewing, or dissolving oxymorphone ER tablets can cause rapid release and absorption of a potentially fatal dose of oxymorphone .Accidental IngestionAccidental ingestion of even one dose of oxymorphone, especially by children, can result in a fatal overdose of oxymorphone .Neonatal Opioid Withdrawal SyndromeProlonged use of oxymorphone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires..