Dilaudid-5 (Oral)

Risk of Medication ErrorsEnsure accuracy when prescribing, dispensing, and administering HYDROmorphone oral solution. Dosing errors due to confusion between mg and mL can result in accidental overdose and death.Addiction, Abuse, and MisuseHYDROmorphone 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 HYDROmorphone, 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 HYDROmorphone. Monitor for respiratory depression, especially during initiation of HYDROmorphone or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of HYDROmorphone, especially by children, can result in a fatal overdose of HYDROmorphone.Neonatal Opioid Withdrawal SyndromeProlonged use of HYDROmorphone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires..