morphine sulfate injection, USP 50 MG/ML VIAL Highlights

Morphine Sulfate Injection is an opioid agonist indicated in adult and pediatric patients 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 Morphine Sulfate Injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):

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Have not been tolerated or are not expected to be tolerated

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Have not provided adequate analgesia or are not expected to provide adequate analgesia

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.‎

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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)‎

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Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher ‎doses of 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. (2.1, 5)‎

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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)‎

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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)‎

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Respiratory depression can occur at any time during opioid therapy, ‎especially when initiating and following dosage increases with ‎Morphine ‎Sulfate Injection. Consider this risk when selecting an initial ‎dose and when making dose adjustments. (2.1, 5.2)‎

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Do not inject directly. Morphine Sulfate Injection is intended for continuous intravenous infusion only, after dilution in large volume parenteral solutions. (2.1, 2.5)

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Initial and maintenance dosage in adults: See full prescribing information for recommended dosages in adult patients. (2.2, 2.3)

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Initial and maintenance dosage in pediatric patients: See full prescribing information for recommended dosage in pediatric patients. (2.2, 2.3)

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Do not abruptly discontinue Morphine Sulfate Injection in a physically‑dependent patient. (2.4)

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See full prescribing information for preparation and storage instructions. (2.5)

Morphine Sulfate Injection, USP is available in 1,000 mg/20 mL (50 mg/mL) and 2,500 mg/50 mL (50 mg/mL) single-dose flip top vials. (3)

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Significant respiratory depression. (4)

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Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)

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Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. (4)

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Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)

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Hypersensitivity to morphine. (4)

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Cardiovascular Instability: High doses are excitatory. Have naloxone injection and resuscitative equipment immediately available. (5.5)

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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. ‎‎(5.6)‎

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Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.7)

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Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.9)

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Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. (5.10)

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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. (5.11)

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, constipation, and diaphoresis. (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.

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Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Morphine Sulfate Injection if serotonin syndrome is suspected. (7)

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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)

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Pregnancy: May cause fetal harm. (8.1)

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