morphine sulfate injection, USP VIAL Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PRESERVATIVE-FREE MORPHINE SULFATE INJECTION, USP safely and effectively. See full prescribing information for PRESERVATIVE-FREE MORPHINE SULFATE INJECTION.

PRESERVATIVE-FREE MORPHINE SULFATE INJECTION for intravenous, epidural, or intrathecal use, CII
Initial U.S. Approval: 1941

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF PRESERVATIVE-FREE MORPHINE SULFATE INJECTION

See full prescribing information for complete boxed warning.

Single-dose neuraxial administration may result in acute or delayed respiratory depression up to 24 hours. Because of the risk of severe adverse reactions when preservative-free morphine sulfate injection is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose. (5.1)
Preservative-free morphine sulfate injection exposes users to risks of opioid 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. (5.2)
Serious, life-threatening, or fatal respiratory depression may occur with use of preservative-free morphine sulfate injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Preservative-free morphine sulfate injection are essential. (5.3)
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. (5.4, 7)
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. (5.5)

RECENT MAJOR CHANGES

Boxed Warning

12/2023

Indications and Usage (1)

12/2023

Dosage and Administration (2.2, 2.3)

12/2023

Warnings and Precautions (5.8)

12/2023

INDICATIONS AND USAGE

Preservative-free morphine sulfate injection is an opioid agonist, indicated for:

1.
the management of pain severe enough to require use of an opioid analgesic by intravenous administration and for which alternative treatments are not expected to be adequate.
2.
the epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function. (1)

Limitations of Use (1)

Preservative-free morphine sulfate injection is not for use in Continuous Microinfusion Devices.

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (5.2), reserve preservative-free morphine sulfate 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

Preservative-free morphine sulfate 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

Preservative-free morphine sulfate 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)
Should be administered by or under the direction of a physician experienced in the techniques of epidural or intrathecal administration. (2.1)
Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of preservative-free morphine sulfate 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. (2.2, 5)
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. (2.1,5.2)
Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with preservative-free morphine sulfate injection. Consider this risk when selecting an initial dose and when making dose adjustments. (2, 5.3)
Dosage for Intravenous Administration: 2 mg to 10 mg/70 kg of body weight. (2.3)
Dosage for Epidural Administration: Initial injection of 5 mg in the lumbar region may provide satisfactory pain relief for up to 24 hours. If adequate pain relief is not achieved within one hour, carefully administer incremental doses of 1 to 2 mg at intervals sufficient to assess effectiveness. Administer no more than 10 mg/24 hr. (2.4)
Dosage for Intrathecal Administration: A single injection of 0.2 to 1 mg may provide satisfactory pain relief for up to 24 hours. Repeated intrathecal injections of preservative-free morphine sulfate injection are not recommended. (2.5)
Do not abruptly discontinue preservative-free morphine sulfate injection abruptly in a physically-dependent patient. (2.6, 5.16)

DOSAGE FORMS AND STRENGTHS

Injection: 5 mg/10 mL (0.5 mg/mL) Preservative-free fliptop vials

Injection: 10 mg/10 mL (1 mg/mL) Preservative-free fliptop vials (3)

CONTRAINDICATIONS

Preservative-free morphine sulfate injection is contraindicated in patients with:

Significant respiratory depression (4)
Acute or severe bronchial asthma in an unmonitored setting in absence of resuscitative equipment (4)
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days (4)
Known or suspected gastrointestinal obstruction, including paralytic ileus (4)
Hypersensitivity or intolerance to morphine (4)

Neuraxial administration of preservative-free morphine sulfate injection is contraindicated in patients with:

Infection at the injection microinfusion site (4)
Concomitant anticoagulant therapy (4)
Uncontrolled bleeding diathesis (4)
The presence of any other concomitant therapy or medical condition which would render epidural or intrathecal administration of medication especially hazardous. (4)

WARNINGS AND PRECAUTIONS

Risk of Tolerance and Myoclonic Activity: Monitor patients for unusual acceleration of neuraxial morphine, which may cause myoclonic-like spasm of lower extremities. Detoxification may be required. (5.6)
Chest Wall Rigidity: Rapid intravenous administration may result in chest wall rigidity. (5.7)
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 a patient is suspected to be experiencing OIH, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation (safely switching the patient to a different opioid moiety). (5.8)
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.9)
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.11)
Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of preservative-free morphine sulfate injection in patients with circulatory shock. (5.12)
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 preservative-free morphine sulfate injection in patients with impaired consciousness or coma. (5.13)

ADVERSE REACTIONS

Most serious adverse reactions were respiratory depression and/or respiratory 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 preservative-free morphine sulfate injection if serotonin syndrome is suspected. (7)
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with preservative-free morphine sulfate injection because they may reduce the analgesic effect of preservative-free morphine sulfate injection or precipitate withdrawal symptoms. (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2024

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PRESERVATIVE-FREE MORPHINE SULFATE INJECTION, USP safely and effectively. See full prescribing information for PRESERVATIVE-FREE MORPHINE SULFATE INJECTION.

PRESERVATIVE-FREE MORPHINE SULFATE INJECTION for intravenous, epidural, or intrathecal use, CII
Initial U.S. Approval: 1941

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF PRESERVATIVE-FREE MORPHINE SULFATE INJECTION

See full prescribing information for complete boxed warning.

Single-dose neuraxial administration may result in acute or delayed respiratory depression up to 24 hours. Because of the risk of severe adverse reactions when preservative-free morphine sulfate injection is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose. (5.1)
Preservative-free morphine sulfate injection exposes users to risks of opioid 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. (5.2)
Serious, life-threatening, or fatal respiratory depression may occur with use of preservative-free morphine sulfate injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Preservative-free morphine sulfate injection are essential. (5.3)
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. (5.4, 7)
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. (5.5)

RECENT MAJOR CHANGES

Boxed Warning

12/2023

Indications and Usage (1)

12/2023

Dosage and Administration (2.2, 2.3)

12/2023

Warnings and Precautions (5.8)

12/2023

INDICATIONS AND USAGE

Preservative-free morphine sulfate injection is an opioid agonist, indicated for:

1.
the management of pain severe enough to require use of an opioid analgesic by intravenous administration and for which alternative treatments are not expected to be adequate.
2.
the epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function. (1)

Limitations of Use (1)

Preservative-free morphine sulfate injection is not for use in Continuous Microinfusion Devices.

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (5.2), reserve preservative-free morphine sulfate 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

Preservative-free morphine sulfate 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

Preservative-free morphine sulfate 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)
Should be administered by or under the direction of a physician experienced in the techniques of epidural or intrathecal administration. (2.1)
Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of preservative-free morphine sulfate 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. (2.2, 5)
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. (2.1,5.2)
Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with preservative-free morphine sulfate injection. Consider this risk when selecting an initial dose and when making dose adjustments. (2, 5.3)
Dosage for Intravenous Administration: 2 mg to 10 mg/70 kg of body weight. (2.3)
Dosage for Epidural Administration: Initial injection of 5 mg in the lumbar region may provide satisfactory pain relief for up to 24 hours. If adequate pain relief is not achieved within one hour, carefully administer incremental doses of 1 to 2 mg at intervals sufficient to assess effectiveness. Administer no more than 10 mg/24 hr. (2.4)
Dosage for Intrathecal Administration: A single injection of 0.2 to 1 mg may provide satisfactory pain relief for up to 24 hours. Repeated intrathecal injections of preservative-free morphine sulfate injection are not recommended. (2.5)
Do not abruptly discontinue preservative-free morphine sulfate injection abruptly in a physically-dependent patient. (2.6, 5.16)

DOSAGE FORMS AND STRENGTHS

Injection: 5 mg/10 mL (0.5 mg/mL) Preservative-free fliptop vials

Injection: 10 mg/10 mL (1 mg/mL) Preservative-free fliptop vials (3)

CONTRAINDICATIONS

Preservative-free morphine sulfate injection is contraindicated in patients with:

Significant respiratory depression (4)
Acute or severe bronchial asthma in an unmonitored setting in absence of resuscitative equipment (4)
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days (4)
Known or suspected gastrointestinal obstruction, including paralytic ileus (4)
Hypersensitivity or intolerance to morphine (4)

Neuraxial administration of preservative-free morphine sulfate injection is contraindicated in patients with:

Infection at the injection microinfusion site (4)
Concomitant anticoagulant therapy (4)
Uncontrolled bleeding diathesis (4)
The presence of any other concomitant therapy or medical condition which would render epidural or intrathecal administration of medication especially hazardous. (4)

WARNINGS AND PRECAUTIONS

Risk of Tolerance and Myoclonic Activity: Monitor patients for unusual acceleration of neuraxial morphine, which may cause myoclonic-like spasm of lower extremities. Detoxification may be required. (5.6)
Chest Wall Rigidity: Rapid intravenous administration may result in chest wall rigidity. (5.7)
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 a patient is suspected to be experiencing OIH, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation (safely switching the patient to a different opioid moiety). (5.8)
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.9)
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.11)
Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of preservative-free morphine sulfate injection in patients with circulatory shock. (5.12)
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 preservative-free morphine sulfate injection in patients with impaired consciousness or coma. (5.13)

ADVERSE REACTIONS

Most serious adverse reactions were respiratory depression and/or respiratory 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 preservative-free morphine sulfate injection if serotonin syndrome is suspected. (7)
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with preservative-free morphine sulfate injection because they may reduce the analgesic effect of preservative-free morphine sulfate injection or precipitate withdrawal symptoms. (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2024

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