hydromorphone hydrochloride injection, USP Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION.

HYDROMORPHONE HYDROCHLORIDE injection, for intravenous, intramuscular, or subcutaneous use, CII
Initial U.S. Approval: 1984

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

See full prescribing information for complete boxed warning.

Hydromorphone Hydrochloride Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. (5.1)
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. (5.2)
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 for use in patients for whom alternative treatment options are inadequate. (5.3, 7)
If opioid use is required for 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. (5.4)

RECENT MAJOR CHANGES

Boxed Warning

12/2023

Indications and Usage (1)‎

12/2023

Dosage and Administration (2.1, 2.2, 2.5)‎

12/2023

Warnings and Precautions (5.5)

12/2023

INDICATIONS AND USAGE

Hydromorphone Hydrochloride Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)

Limitations of Use: (1)

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (5.1), reserve Hydromorphone Hydrochloride Injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):

Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Hydromorphone Hydrochloride Injection should not be used for an extended ‎period of time unless the pain remains severe enough to require an opioid ‎analgesic and for which alternative treatment options continue to be inadequate.

DOSAGE AND ADMINISTRATION

Hydromorphone Hydrochloride Injection should be ‎prescribed only by healthcare professionals who are ‎knowledgeable about the use of opioids and how to ‎mitigate the associated risks. (2.1)‎
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Reserve titration to higher doses of Hydromorphone ‎Hydrochloride Injection for patients in whom lower doses are insufficiently ‎effective and in whom the expected benefits of using a higher dose opioid ‎clearly outweigh the substantial risks. (2.1, 5)
Many acute pain conditions (e.g., the pain that occurs with ‎a number of surgical procedures or acute ‎musculoskeletal injuries) require no more than a few ‎days of an opioid analgesic. Clinical guidelines on ‎opioid prescribing for some acute pain conditions are ‎available. (2.1)‎
Initiate the dosing regimen for each patient individually, ‎taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and ‎response, and risk factors for addiction, abuse, and misuse. (2.1, 5.1)
Respiratory depression can occur at any time during opioid ‎therapy, especially when initiating and following dosage ‎increases with Hydromorphone Hydrochloride Injection. ‎Consider this risk when selecting an initial dose and when ‎making dose adjustments. (2.1, 5.2)‎
Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1)
Intramuscular and Subcutaneous Use: The usual starting dose is 1 mg to 2 mg every 2 to 3 hours as necessary. (2.2)
Intravenous Use: The usual starting dose is 0.2 mg to 1 mg every 2 to 3 hours. The injection should be given slowly, over at least 2 to 3 minutes. (2.2)
Hepatic Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of hepatic impairment. (2.3)
Renal Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of renal impairment. (2.4)
Do not abruptly discontinue Hydromorphone Hydrochloride Injection in a physically-dependent patient. (2.6)

DOSAGE FORMS AND STRENGTHS

Injection: 0.5 mg/0.5 mL, 1 mg/mL, 2 mg/mL and 4 mg/mL is available in single-dose ampuls, single-dose Carpuject™ cartridges with Luer Lock for use with the Carpuject™ Syringe System‎, single-dose iSecure™ prefilled syringes with Luer Lock, and single-dose vials for parenteral administration. (3)

CONTRAINDICATIONS

Significant respiratory depression. (4)
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)
Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)
Known hypersensitivity to hydromorphone. (4)

WARNINGS AND PRECAUTIONS

Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced ‎Hyperalgesia (OIH) occurs when an opioid analgesic ‎paradoxically causes an increase in pain, or an increase in ‎sensitivity to pain. If OIH is suspected, carefully consider appropriately ‎decreasing the dose of the current opioid analgesic or ‎opioid rotation. (5.5)‎
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.6)
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.7)
Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Hydromorphone Hydrochloride Injection in patients with circulatory shock. (5.8)
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Hydromorphone Hydrochloride Injection in patients with impaired consciousness or coma. (5.9)

ADVERSE REACTIONS

Most common adverse reactions are light-headedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.

Serious adverse reactions include respiratory depression and apnea, circulatory depression, respiratory arrest, shock and cardiac arrest. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov.medwatch.

DRUG INTERACTIONS

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Hydromorphone Hydrochloride Injection if serotonin syndrome is suspected. (7)
Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of hydromorphone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI. (7)
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Hydromorphone Hydrochloride Injection because they may reduce analgesic effect of Hydromorphone Hydrochloride Injection or precipitate withdrawal symptoms. (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. (8.1)
Geriatric Patients: Use caution during dose selection, starting at the low ‎end of the dosing range while carefully monitoring for side effects. ‎‎(8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION.

HYDROMORPHONE HYDROCHLORIDE injection, for intravenous, intramuscular, or subcutaneous use, CII
Initial U.S. Approval: 1984

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

See full prescribing information for complete boxed warning.

Hydromorphone Hydrochloride Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. (5.1)
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. (5.2)
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 for use in patients for whom alternative treatment options are inadequate. (5.3, 7)
If opioid use is required for 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. (5.4)

RECENT MAJOR CHANGES

Boxed Warning

12/2023

Indications and Usage (1)‎

12/2023

Dosage and Administration (2.1, 2.2, 2.5)‎

12/2023

Warnings and Precautions (5.5)

12/2023

INDICATIONS AND USAGE

Hydromorphone Hydrochloride Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)

Limitations of Use: (1)

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (5.1), reserve Hydromorphone Hydrochloride Injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):

Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Hydromorphone Hydrochloride Injection should not be used for an extended ‎period of time unless the pain remains severe enough to require an opioid ‎analgesic and for which alternative treatment options continue to be inadequate.

DOSAGE AND ADMINISTRATION

Hydromorphone Hydrochloride Injection should be ‎prescribed only by healthcare professionals who are ‎knowledgeable about the use of opioids and how to ‎mitigate the associated risks. (2.1)‎
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Reserve titration to higher doses of Hydromorphone ‎Hydrochloride Injection for patients in whom lower doses are insufficiently ‎effective and in whom the expected benefits of using a higher dose opioid ‎clearly outweigh the substantial risks. (2.1, 5)
Many acute pain conditions (e.g., the pain that occurs with ‎a number of surgical procedures or acute ‎musculoskeletal injuries) require no more than a few ‎days of an opioid analgesic. Clinical guidelines on ‎opioid prescribing for some acute pain conditions are ‎available. (2.1)‎
Initiate the dosing regimen for each patient individually, ‎taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and ‎response, and risk factors for addiction, abuse, and misuse. (2.1, 5.1)
Respiratory depression can occur at any time during opioid ‎therapy, especially when initiating and following dosage ‎increases with Hydromorphone Hydrochloride Injection. ‎Consider this risk when selecting an initial dose and when ‎making dose adjustments. (2.1, 5.2)‎
Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1)
Intramuscular and Subcutaneous Use: The usual starting dose is 1 mg to 2 mg every 2 to 3 hours as necessary. (2.2)
Intravenous Use: The usual starting dose is 0.2 mg to 1 mg every 2 to 3 hours. The injection should be given slowly, over at least 2 to 3 minutes. (2.2)
Hepatic Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of hepatic impairment. (2.3)
Renal Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of renal impairment. (2.4)
Do not abruptly discontinue Hydromorphone Hydrochloride Injection in a physically-dependent patient. (2.6)

DOSAGE FORMS AND STRENGTHS

Injection: 0.5 mg/0.5 mL, 1 mg/mL, 2 mg/mL and 4 mg/mL is available in single-dose ampuls, single-dose Carpuject™ cartridges with Luer Lock for use with the Carpuject™ Syringe System‎, single-dose iSecure™ prefilled syringes with Luer Lock, and single-dose vials for parenteral administration. (3)

CONTRAINDICATIONS

Significant respiratory depression. (4)
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)
Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)
Known hypersensitivity to hydromorphone. (4)

WARNINGS AND PRECAUTIONS

Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced ‎Hyperalgesia (OIH) occurs when an opioid analgesic ‎paradoxically causes an increase in pain, or an increase in ‎sensitivity to pain. If OIH is suspected, carefully consider appropriately ‎decreasing the dose of the current opioid analgesic or ‎opioid rotation. (5.5)‎
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.6)
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.7)
Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Hydromorphone Hydrochloride Injection in patients with circulatory shock. (5.8)
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Hydromorphone Hydrochloride Injection in patients with impaired consciousness or coma. (5.9)

ADVERSE REACTIONS

Most common adverse reactions are light-headedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.

Serious adverse reactions include respiratory depression and apnea, circulatory depression, respiratory arrest, shock and cardiac arrest. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov.medwatch.

DRUG INTERACTIONS

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Hydromorphone Hydrochloride Injection if serotonin syndrome is suspected. (7)
Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of hydromorphone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI. (7)
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Hydromorphone Hydrochloride Injection because they may reduce analgesic effect of Hydromorphone Hydrochloride Injection or precipitate withdrawal symptoms. (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. (8.1)
Geriatric Patients: Use caution during dose selection, starting at the low ‎end of the dosing range while carefully monitoring for side effects. ‎‎(8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2023

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