Crushing, chewing, or dissolving the tablets or contents within the capsule can cause rapid release and absorption of a potentially fatal dose of morphine. ER capsule contents may be sprinkled on applesauce and swallowed immediately without chewing. Monitor for respiratory depression, especially during initiation of morphine or following a dose increase. Serious, life-threatening, or fatal respiratory depression may occur with use of morphine. Health care 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. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS compliant education programs available to health care providers. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Opioid analgesic Risk Evaluation and Mitigation Strategy (REMS): Assess each patient's risk prior to prescribing morphine and monitor all patients regularly for the development of these behaviors and conditions. Morphine exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. The coingestion of alcohol with morphine ER may result in increased plasma levels and a potentially fatal overdose of morphine. Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while taking morphine extended-release (ER) capsules. Monitor patients receiving Infumorph or Mitigo, as appropriate, for the first several days after catheter implantation. Single-dose Duramorph neuraxial administration may result in acute or delayed respiratory depression for up to 24 hours.
Risks with neuroaxial administration (Infumorph, Duramorph, Mitigo):īecause of the risk of severe adverse effects when the epidural or intrathecal route of administration is employed, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose.
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