morphine sulfate injection, USP NEXJECT, CARPUJECT Dosage and Administration

2.1 Important Dosage and Administration Instructions

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Morphine Sulfate Injection is for intravenous administration.

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Morphine Sulfate Injection is available in five concentrations as Carpuject™ cartridges for use with the Carpuject Holder ONLY, and in four concentrations as NexJect™ syringes for intravenous administration. Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with morphine injections of different concentrations when prescribing, dispensing, and administering Morphine Sulfate Injection. Ensure that the dose is communicated and dispensed accurately.

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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.

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Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5)].Because the risk of overdose increases as opioid doses ‎increase, 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.‎

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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.‎

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There is variability in the opioid analgesic dose and duration needed to ‎adequately manage pain due both to the cause of pain and to ‎individual patient factors. 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 [see Warnings and Precautions (5.1)].

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Respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases with Morphine Sulfate Injection and adjust the dosage accordingly [see Warnings and Precautions (5.2)].

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Morphine must be injected slowly; rapid intravenous administration may result in chest wall rigidity.

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Inspect Morphine Sulfate Injection for particulate matter and discoloration prior to administration. Do not use if color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate.

2.2 Initial Dosage

2.3 Titration and Maintenance of Therapy

Titrate the dose based upon the individual patient’s response to their initial dose ‎of Morphine Sulfate Injection.‎ Individually titrate Morphine Sulfate Injection to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Morphine Sulfate Injection to assess the maintenance of pain control, signs and symptoms of opioid withdrawal,‎ and other adverse reactions, as well as to reassess for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1, 5.14)]. If after increasing the dosage, unacceptable opioid-related adverse reactions are observed, (including an increase in pain after dosage increase)‎,‎ consider reducing the dosage [see Warnings and Precautions (5)]‎. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

2.4 Discontinuation of Morphine Sulfate Injection

When a patient who has been taking Morphine Sulfate Injection regularly and may be physically dependent no longer requires therapy with Morphine Sulfate Injection, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Morphine Sulfate Injection in a physically-dependent patient [see Warnings and Precautions (5.14), Drug Abuse and Dependence (9.3)].