Opana ER 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 Opana ER, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ].
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 [see Warnings and Precautions]. 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 Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of Opana ER. Monitor for respiratory depression, especially during initiation of Opana ER or following a dose increase. Instruct patients to swallow Opana ER tablets whole; crushing, chewing, or dissolving Opana ER tablets can cause rapid release and absorption of a potentially fatal dose of oxymorphone [see Warnings and Precautions].
Accidental ingestion of even one dose of Opana ER, especially by children, can result in a fatal overdose of oxymorphone [see Warnings and Precautions].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of Opana ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions].
Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking Opana ER. The co-ingestion of alcohol with Opana ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone [see Warnings and Precautions].
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 [see Warnings and Precautions, Drug Interactions.
- Reserve concomitant prescribing of Opana ER 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.
- Follow patients for signs and symptoms of respiratory depression and sedation.
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