Risk of Medication Errors; Abuse Potential; Respiratory Depression; Accidental Ingestion; Neonatal Withdrawal; Risks from Concomitant Use with Benzodiazepines or othoer CNS Depressants; Risk Evaluation and Mitigation Strategy (REMS)

Risk of Medication Errors 

• Ensure 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 Misuse 

• Hydromorphone Oral Solution and Tablets expose 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 Oral Solution or Tablets, and monitor all patients regularly for the development of these behaviors and conditions.
• Patients at increased risk may be prescribed opioids, but use in such patients necessitates intensive counseling about the risks and proper use along with intensive monitoring for signs of addiction, abuse, and misuse. Consider prescribing naloxone for the emergency treatment of opioid overdose. 

Life-Threatening Respiratory Depression

• Serious, life-threatening, or fatal respiratory depression may occur with use of Hydromorphone Oral Solution and Tablets. Monitor for respiratory depression, especially during initiation of Hydromorphone Oral Solution or Tablets or following a dose increase.
• Do not abruptly discontinue DILAUDID ORAL SOLUTION OR DILAUDID TABLETS in a patient physically dependent on opioids. When discontinuing DILAUDID Oral Solution or DILAUDID Tablets in a physically dependent patient, gradually taper the dosage. Rapid tapering of hydromorphone in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain.
• 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.

Accidental Ingestion 

• Accidental ingestion of even one dose of Hydromorphone Oral Solution or Tablets, especially by children, can result in a fatal overdose of hydromorphone.

Neonatal Opioid Withdrawal Syndrome 

• Prolonged use of Hydromorphone Oral Solution or Tablets 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.
• Reserve concomitant prescribing of Hydromorphone Oral Solution or Tablets 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.

Risk Evaluatopn 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.