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MORPHINE SULFATE (NEXTJECT) Highlights (morphine sulfate injection, USP)

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

MORPHINE SULFATE INJECTION, PRESERVATIVE-FREE, Solution for Intravenous Use, CII

Initial U.S. Approval: 1941

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

See full prescribing information for complete boxed warning.

  • 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. (5.1)
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.2)
  • Prolonged use of 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. (5.3)
  • 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; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.4, 7)

INDICATIONS AND USAGE

Morphine Sulfate 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, even at recommended doses, reserve 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

DOSAGE AND ADMINISTRATION

  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (2.1)
  • Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1)
  • Direct Intravenous Injection: The usual starting dose in adults is 0.1 mg to 0.2 mg per kg every 4 hours as needed for pain management. (2.2)
  • Do not stop Morphine Sulfate Injection abruptly in a physically dependent patient. (2.4)

DOSAGE FORMS AND STRENGTHS

  • Morphine Sulfate Injection, USP, 2 mg/mL, 4 mg/mL, 8 mg/mL, and 10 mg/mL available in NexJect™ Single-dose Prefilled Syringe for intravenous administration. (3)

CONTRAINDICATIONS

  • Significant respiratory depression. (4)
  • Acute or severe bronchial asthma in an unmonitored setting or 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 to morphine. (4)

WARNINGS AND PRECAUTIONS

  • Cardiovascular Instability: High doses are excitatory. Have naloxone injection and resuscitative equipment immediately available. (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. (5.8)
  • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. (5. 9)
  • 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 Morphine Sulfate Injection in patients with impaired consciousness or coma. (5.10)

ADVERSE REACTIONS

The most serious adverse reactions encountered are respiratory depression, apnea, circulatory depression, respiratory arrest, shock, and cardiac arrest. Other common frequently observed adverse reactions include: sedation, lightheadedness, dizziness, nausea, vomiting, and constipation. (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 Morphine Sulfate Injection if serotonin syndrome is suspected. (7)
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Morphine Sulfate Injection because they may reduce analgesic effect of 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: 2/2021

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