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HYDROMORPHONE HYDROCHLORIDE, Vial U.S. Physician Prescribing Information (hydromorphone hydrochloride injection, USP) Boxed Warning

WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Risk of Medication Errors

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is a more concentrated solution of hydromorphone, and is for use in opioid-tolerant patients only. Do not confuse Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] with standard parenteral formulations of hydromorphone, as overdose and death could result [see Warnings and Precautions (5.1)].

Addiction, Abuse, and Misuse

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] 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 Hydrochloride Injection [high potency formulation (HPF)] and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.2)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Monitor for respiratory depression, especially during initiation of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] or following a dose increase [see Warnings and Precautions (5.3)].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] 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 [see Warnings and Precautions (5.4)].

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 and Precautions (5.5), Drug Interactions (7)].

  • Reserve concomitant prescribing of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] 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.

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