Continuous Intravenous Infusion
Use the lowest dose necessary to achieve adequate analgesia.
Adults
Adults: Initiate treatment in a dosing range of 0.02 mg/kg/hour to 0.1 mg/kg/hour as needed. The dosage should be titrated according to the patient's response [see Dosage and Administration (2.3)].
For opioid-naïve patients, a maximum dosing rate should not exceed 10 mg/hour.
For opioid-tolerant patients, including patients who, because of their condition, have a high analgesic requirement (e.g., terminal cancer pain), dosing rates as high as 30 mg/hour or higher may be required to manage pain.
Pediatric patients
Patients 1 to less than 17 years old:
Initiate intravenous infusion in patients 1 to less than 17 years old is as follows:
Patients less than 1 year old, including neonates:
The dosage should be titrated according to the patient's response [see Dosage and Administration (2.3)]. For opioid-tolerant patients, including patients with a high analgesic requirement (e.g., terminal cancer pain, sickle-cell disease crisis), higher initial doses may be required.
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 dosage 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 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.
Pediatric patients
Patients 1 to less than 17 years old:
Recommended maintenance dosage for patients 1 to less than 17 years old is as follows:
The maintenance dosage in pediatric patients should be adjusted based on individual patient's needs to obtain an appropriate balance between effective pain management and opioid-related adverse reactions.
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)].
Morphine Sulfate Injection is incompatible with admixtures of soluble barbiturates, chlorothiazide, aminophylline, heparin, meperidine, methicillin, phenytoin, sodium bicarbonate, iodide, sulfadiazine and sulfisoxazole.
Single-dose Flip Top Vial
Morphine Sulfate Injection USP, 1,000 mg/20 mL (50 mg/mL), and 2,500 mg/50 mL (50 mg/mL) single-dose vials are for the preparation of large volume parenteral solutions and are not for direct injection.
Dilute Morphine Sulfate Injection in either Dextrose 5% injection or Sodium Chloride 0.9% injection to a final concentration of 0.1 mg/mL to 5 mg/mL, as determined by the patient's needs, prior to administration (see Table 1 for instructions regarding dilution). Preparations in Sodium Chloride 0.9% injection are stable for 14 days at room temperature [20°C to 25°C (68°F to 77°F)] or under refrigerated conditions [2°C to 8°C (36°F to 46°F)]. Preparations in Dextrose 5% injection are stable for up to 72 hours at room temperature [20°C to 25°C (68°F to 77°F)] or for 14 days under refrigerated conditions [2°C to 8°C (36°F to 46°F)].
| Concentration | Diluent | Final Concentration Morphine Sulfate |
|---|---|---|
Morphine 50 mg/mL | 5% Dextrose or 0.9% NaCl | |
20 mL vial | 980 mL | 1 mg/mL |
50 mL vial | 950 mL | 2.5 mg/mL |
Continuous Intravenous Infusion
Use the lowest dose necessary to achieve adequate analgesia.
Adults
Adults: Initiate treatment in a dosing range of 0.02 mg/kg/hour to 0.1 mg/kg/hour as needed. The dosage should be titrated according to the patient's response [see Dosage and Administration (2.3)].
For opioid-naïve patients, a maximum dosing rate should not exceed 10 mg/hour.
For opioid-tolerant patients, including patients who, because of their condition, have a high analgesic requirement (e.g., terminal cancer pain), dosing rates as high as 30 mg/hour or higher may be required to manage pain.
Pediatric patients
Patients 1 to less than 17 years old:
Initiate intravenous infusion in patients 1 to less than 17 years old is as follows:
Patients less than 1 year old, including neonates:
The dosage should be titrated according to the patient's response [see Dosage and Administration (2.3)]. For opioid-tolerant patients, including patients with a high analgesic requirement (e.g., terminal cancer pain, sickle-cell disease crisis), higher initial doses may be required.
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 dosage 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 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.
Pediatric patients
Patients 1 to less than 17 years old:
Recommended maintenance dosage for patients 1 to less than 17 years old is as follows:
The maintenance dosage in pediatric patients should be adjusted based on individual patient's needs to obtain an appropriate balance between effective pain management and opioid-related adverse reactions.
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)].
Morphine Sulfate Injection is incompatible with admixtures of soluble barbiturates, chlorothiazide, aminophylline, heparin, meperidine, methicillin, phenytoin, sodium bicarbonate, iodide, sulfadiazine and sulfisoxazole.
Single-dose Flip Top Vial
Morphine Sulfate Injection USP, 1,000 mg/20 mL (50 mg/mL), and 2,500 mg/50 mL (50 mg/mL) single-dose vials are for the preparation of large volume parenteral solutions and are not for direct injection.
Dilute Morphine Sulfate Injection in either Dextrose 5% injection or Sodium Chloride 0.9% injection to a final concentration of 0.1 mg/mL to 5 mg/mL, as determined by the patient's needs, prior to administration (see Table 1 for instructions regarding dilution). Preparations in Sodium Chloride 0.9% injection are stable for 14 days at room temperature [20°C to 25°C (68°F to 77°F)] or under refrigerated conditions [2°C to 8°C (36°F to 46°F)]. Preparations in Dextrose 5% injection are stable for up to 72 hours at room temperature [20°C to 25°C (68°F to 77°F)] or for 14 days under refrigerated conditions [2°C to 8°C (36°F to 46°F)].
| Concentration | Diluent | Final Concentration Morphine Sulfate |
|---|---|---|
Morphine 50 mg/mL | 5% Dextrose or 0.9% NaCl | |
20 mL vial | 980 mL | 1 mg/mL |
50 mL vial | 950 mL | 2.5 mg/mL |
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