Life-Threatening Respiratory Depression and Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants

Life-Threatening Respiratory Depression

• Serious, life-threatening, or fatal respiratory depression may occur with use of Nalbuphine Hydrochloride Injection, particularly when used concomitantly with other opioids or central nervous system depressants. Monitor for respiratory depression, especially during initiation of Nalbuphine Hydrochloride Injection or following a dose increase [see WARNINGS].
• Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper.

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, PRECAUTIONS; DRUG INTERACTIONS].     
          Reserve concomitant prescribing of nalbuphine hydrochloride 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.