Important Safety Information

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

Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering DILAUDID Oral Solution. Dosing errors due to confusion between mg and mL can result in accidental overdose and death [see Dosage and Administration (2.1), Warnings and Precautions (5.1)].

Addiction, Abuse, and Misuse
DILAUDID Oral Solution and DILAUDID 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 DILAUDID Oral Solution or DILAUDID Tablets, 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 DILAUDID Oral Solution and DILAUDID Tablets.  Monitor for respiratory depression, especially during initiation of DILAUDID Oral Solution or DILAUDID Tablets or following a dose increase [see Warnings and Precautions (5.3)].

Accidental Ingestion
Accidental ingestion of even one dose of DILAUDID Oral Solution or DILAUDID Tablets, especially by children, can result in a fatal overdose of hydromorphone [see Warnings and Precautions (5.3)].

Neonatal Opioid Withdrawal Syndrome
Prolonged use of DILAUDID Oral Solution or DILAUDID 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 [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 DILAUDID Oral Solution OR DILAUDID Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Dilaudid® (hydromorphone HCl) Oral Solution CII

Dilaudid® (hydromorphone HCl) Tablets CII

Please read the Full Prescribing Information, including Boxed Warning, for information about Dilaudid Oral Solution and Tablets.

 

Important Safety Information

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

Risk of Medication Errors:
DILAUDID-HP INJECTION is a more concentrated solution of hydromorphone than DILAUDID INJECTION, and is for use in opioid-tolerant patients only. Do not confuse DILAUDID-HP INJECTION with standard parenteral formulations of DILAUDID INJECTION or other opioids, as overdose and death could result [see Warnings and Precautions (5.1)].

Addiction, Abuse, and Misuse
DILAUDID INJECTION and DILAUDID-HP INJECTION 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 DILAUDID INJECTION and DILAUDID-HP INJECTION 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 DILAUDID INJECTION or DILAUDID-HP INJECTION.  Monitor for respiratory depression, especially during initiation of DILAUDID INJECTION or DILAUDID-HP INJECTION or following a dose increase [see Warnings and Precautions (5.3)]

Neonatal Opioid Withdrawal Syndrome
Prolonged use of DILAUDID INJECTION or DILAUDID-HP INJECTION 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 DILAUDID or DILAUDID-HP Injection 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.

Dilaudid® Injection (hydromorphone HCl) CII

Dilaudid-HP® Injection (hydromorphone HCl) CII

Please read the Full Prescribing Information, including Boxed Warning, for information about Dilaudid Injectable products.

The Safety Data Sheet for

    • Dilaudid Oral Solution is here.
    • Dilaudid Tablets is here.
    • Dilaudid 1, 2, and 4 mg/mL Injectable is here.

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