HYDROMORPHONE (NEXJECT) Boxed Warning

(hydromorphone hydrochloride injection, USP)

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ‎HYDROMORPHONE ‎HYDROCHLORIDE INJECTION

Addiction, Abuse, and Misuse

Because use ofHydromorphone Hydrochloride Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assesseach patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Hydromorphone Hydrochloride Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of ‎Hydromorphone ‎Hydrochloride Injection are essential[see Warnings and Precautions (5.2)].

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 Hydrochloride Injection and benzodiazepines or other ‎CNS ‎depressants for use in patients for whom alternative treatment options are ‎inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)].

Neonatal Opioid Withdrawal Syndrome (NOWS)

If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4)].

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Boxed Warning

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ‎HYDROMORPHONE ‎HYDROCHLORIDE INJECTION

Addiction, Abuse, and Misuse

Because use ofHydromorphone Hydrochloride Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assesseach patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Hydromorphone Hydrochloride Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of ‎Hydromorphone ‎Hydrochloride Injection are essential[see Warnings and Precautions (5.2)].

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 Hydrochloride Injection and benzodiazepines or other ‎CNS ‎depressants for use in patients for whom alternative treatment options are ‎inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)].

Neonatal Opioid Withdrawal Syndrome (NOWS)

If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4)].

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