Astramorph PF (Injection)

Risks with Neuroaxial Administration:Single-dose neuraxial administration may result in acute or delayed respiratory depression up to 24 hours. Because of the risk of severe adverse reactions when morphine sulfate (Duramorph(R)) is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose . Because of the risk of severe adverse reactions when morphine sulfate (Infumorph(R)) is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial (single) test dose and, as appropriate, for the first several days after catheter implantation .Life-Threatening Respiratory Depression:Serious, life-threatening, or fatal respiratory depression may occur with use of morphine sulfate. Monitor for respiratory depression, especially during initiation of morphine sulfate or following a dose increase . Because of delay in maximum CNS effect with intravenously administered drug (30 min), rapid IV administration may result in overdosing . Patients must be observed in a fully equipped and staffed environment for at least 24 hours after each test dose of Infumorph(R) and, as indicated, for the first several days after surgery .Addiction, Abuse, and Misuse:Morphine sulfate 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 morphine sulfate, and monitor all patients regularly for the development of these behaviors and conditions .Neonatal Opioid Withdrawal Syndrome:Prolonged use of morphine sulfate 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 .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. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation .