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

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)
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Because of delay in maximum CNS effect with intravenously administered drug (30 min), rapid IV administration may result in overdosing. (5.2)
  • Preservative-free morphine sulfate injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. (5.3)
  • Prolonged use of preservative-free morphine sulfate injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.4)
  • 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; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.5, 7)

RECENT MAJOR CHANGES

Warnings and Precautions (5.2)10/2019

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)

Limitation of Use (1)

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

DOSAGE AND ADMINISTRATION

  • Administration should be limited to use by those familiar with the management of respiratory depression. (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 dose for the shortest duration consistent with individual patient treatment goals. (2.2)
  • Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.2)
  • Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases. (2.2)
  • 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 stop preservative-free morphine sulfate injection abruptly in a physically dependent patient. (2.6)

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)
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.8)
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.10)
  • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of preservative-free morphine sulfate injection in patients with circulatory shock. (5.11)
  • 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. (5.12)

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: 12/2019

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

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)
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Because of delay in maximum CNS effect with intravenously administered drug (30 min), rapid IV administration may result in overdosing. (5.2)
  • Preservative-free morphine sulfate injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. (5.3)
  • Prolonged use of preservative-free morphine sulfate injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.4)
  • 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; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.5, 7)

RECENT MAJOR CHANGES

Warnings and Precautions (5.2)10/2019

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)

Limitation of Use (1)

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

DOSAGE AND ADMINISTRATION

  • Administration should be limited to use by those familiar with the management of respiratory depression. (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 dose for the shortest duration consistent with individual patient treatment goals. (2.2)
  • Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.2)
  • Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases. (2.2)
  • 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 stop preservative-free morphine sulfate injection abruptly in a physically dependent patient. (2.6)

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)
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.8)
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.10)
  • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of preservative-free morphine sulfate injection in patients with circulatory shock. (5.11)
  • 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. (5.12)

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: 12/2019
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