MORPHINE SULFATE- morphine sulfate solution
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering morphine sulfate oral solution. Dosing errors due to confusion between mg and mL, and other morphine solutions of different concentrations can result in accidental overdose and death [see Dosage and Administration (2.1), Warnings and Precautions (5.1)].
Addiction, Abuse, and Misuse
Morphine sulfate oral solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing morphine sulfate oral solution, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.2) ].
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautions (5.3) ]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to
- complete a REMS-compliant education program,
- counsel patients and/or their caregivers , with every prescription, on safe use, serious risks , storage, and disposal of these products ,
- emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
- consider other tools to improve patient, household, and community safety.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of morphine sulfate oral solution. Monitor for respiratory depression, especially during initiation of morphine sulfate oral solution or following a dose increase [see Warnings and Precautions (5.4) ].
Accidental ingestion of even one dose of morphine sulfate oral solution, especially by children, can result in a fatal overdose of morphine [see Warnings and Precautions (5.4) ].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of morphine sulfate oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.5) ].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
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 [see Warnings and
Precautions (5.6), Drug Interactions (7) ].
- Reserve concomitant prescribing of morphine sulfate oral solution and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
Morphine sulfate oral solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve morphine sulfate oral solution 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
Morphine sulfate oral solution is available in 20 mg/mL concentration. [see Dosage Forms and Strengths (3)].
- Morphine sulfate oral solution 20 mg/mL is only indicated for use in opioid-tolerant adult patients who have already been receiving opioid therapy. This concentration is to be used only in adult patients who have already been titrated to a stable analgesic regimen using lower concentrations of morphine sulfate and who can benefit from use of a higher concentration (smaller volume) of oral solution.
- Adult patients considered to be opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
- Always use the enclosed calibrated oral syringe when administering morphine sulfate oral solution 20 mg/mL to ensure the dose is measured and administered accurately.
- Ensure accuracy when prescribing, dispensing, and administering morphine sulfate oral solution to avoid dosing errors due to confusion between mg and mL, and with other morphine solutions of different concentrations, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose (in mg) and the total dose in volume (mL).
- Instruct patients on how to accurately measure and take the correct dose of morphine sulfate oral solution.
- Instruct patients to never use household teaspoons or tablespoons to measure morphine sulfate oral solution.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ].
- Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.2) ].
- Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with morphine sulfate oral solution and adjust the dosage accordingly [see Warnings and Precautions (5.4).
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