morphine sulfate injection, USP VIAL Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Do Not Use Preservative-free morphine sulfate injection in Continuous Microinfusion Devices.

Preservative-free morphine sulfate injection should be administered by or under the direction of a physician experienced in the techniques of epidural or intrathecal administration and familiar with the patient management problems associated with epidural or intrathecal drug administration and the labeling, and should take place only in settings where adequate patient monitoring is possible.

•
Preservative-free 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.
•
Because of the risk of delayed respiratory depression, patients should be observed in a fully equipped and staffed environment for at least 24 hours. Respiratory depression (both early and late onset) has occurred more frequently following intrathecal administration than epidural administration.
•
Because epidural administration has been associated with less potential for immediate or late adverse effects than intrathecal administration, the epidural route should be used whenever possible.
•
For safety reasons, it is recommended that administration of preservative-free morphine sulfate injection by the epidural or intrathecal routes be limited to the lumbar area.
•
Have resuscitative equipment and a specific antagonist (naloxone injection) immediately available for the management of respiratory depression as well as complications which might result from inadvertent intrathecal or intravascular injection (note: intrathecal dosage is usually 1/10 that of epidural dosage).

Epidural Administration

Verify proper placement of a needle or catheter in the epidural space before preservative-free morphine sulfate injection is injected.

Acceptable techniques for verifying proper placement include: a) aspiration to check for absence of blood or cerebrospinal fluid, or b) administration of 5 mL (3 mL in obstetric patients) of 1.5% PRESERVATIVE-FREE Lidocaine and Epinephrine (1:200,000) Injection and then observe the patient for lack of tachycardia (this indicates that vascular injection has not been made) and lack of sudden onset of segmental anesthesia (this indicates that intrathecal injection has not been made).

Safety and Handling Instructions

Preservative-free morphine sulfate injection is supplied in sealed vials. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.

Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and vial permit. Do not use if color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate.

Preservative-free morphine sulfate injection is intended for single dose only. Protect from light, discard any unused portion. Do not heat-sterilize.

2.2 Initial Dosage

The starting dose of preservative-free morphine sulfate injection must be individualized.

•
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 preservative-free 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.
•
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.
•
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 (5.2)].
•
Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with preservative-free morphine sulfate injection. Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions (5)].

2.3 Dosage for Intravenous Administration

Adult Dosage: The initial dose of morphine should be 2 mg to 10 mg/70 kg of body weight, and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of preservative-free morphine sulfate injection.

2.4 Dosage for Epidural Administration

Adult Dosage: Initial injection of 5 mg in the lumbar region may provide satisfactory pain relief for up to 24 hours. If adequate pain relief is not achieved within one hour, careful administration of incremental doses of 1 to 2 mg at intervals sufficient to assess effectiveness may be given. Do not administer more than 10 mg per 24 hours.

2.5 Dosage for Intrathecal Administration

Adult Dosage: Intrathecal dosage is usually 1/10 that of epidural dosage. A single injection of 0.2 to 1 mg may provide satisfactory pain relief for up to 24 hours. (Caution: this is only 0.4 to 2 mL of the 5 mg/10 mL vial or 0.2 to 1 mL of the 10 mg/10 mL vial of preservative-free morphine sulfate injection).

•
Do not inject intrathecally more than 2 mL of the 5 mg/10 mL vial or 1 mL of the 10 mg/10 mL vial.
•
Repeated intrathecal injections of preservative-free morphine sulfate injection are not recommended. If pain recurs, consider alternative routes of administration.
•
A constant intravenous infusion of naloxone, 0.6 mg/hr, for 24 hours after intrathecal injection may be used to reduce the incidence of potential side effects.

2.6 Discontinuation of Preservative-Free Morphine Sulfate Injection

When a patient who has been treated with a regimen of opioid analgesics including preservative-free morphine sulfate injection regularly and may be physically-dependent or no longer requires therapy with preservative-free morphine sulfate injection, taper the dose gradually 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 preservative-free morphine sulfate injection in a physically-dependent patient [see Warnings and Precautions (5.16), Drug Abuse and Dependence (9.3)].

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Do Not Use Preservative-free morphine sulfate injection in Continuous Microinfusion Devices.

Preservative-free morphine sulfate injection should be administered by or under the direction of a physician experienced in the techniques of epidural or intrathecal administration and familiar with the patient management problems associated with epidural or intrathecal drug administration and the labeling, and should take place only in settings where adequate patient monitoring is possible.

•
Preservative-free 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.
•
Because of the risk of delayed respiratory depression, patients should be observed in a fully equipped and staffed environment for at least 24 hours. Respiratory depression (both early and late onset) has occurred more frequently following intrathecal administration than epidural administration.
•
Because epidural administration has been associated with less potential for immediate or late adverse effects than intrathecal administration, the epidural route should be used whenever possible.
•
For safety reasons, it is recommended that administration of preservative-free morphine sulfate injection by the epidural or intrathecal routes be limited to the lumbar area.
•
Have resuscitative equipment and a specific antagonist (naloxone injection) immediately available for the management of respiratory depression as well as complications which might result from inadvertent intrathecal or intravascular injection (note: intrathecal dosage is usually 1/10 that of epidural dosage).

Epidural Administration

Verify proper placement of a needle or catheter in the epidural space before preservative-free morphine sulfate injection is injected.

Acceptable techniques for verifying proper placement include: a) aspiration to check for absence of blood or cerebrospinal fluid, or b) administration of 5 mL (3 mL in obstetric patients) of 1.5% PRESERVATIVE-FREE Lidocaine and Epinephrine (1:200,000) Injection and then observe the patient for lack of tachycardia (this indicates that vascular injection has not been made) and lack of sudden onset of segmental anesthesia (this indicates that intrathecal injection has not been made).

Safety and Handling Instructions

Preservative-free morphine sulfate injection is supplied in sealed vials. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.

Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and vial permit. Do not use if color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate.

Preservative-free morphine sulfate injection is intended for single dose only. Protect from light, discard any unused portion. Do not heat-sterilize.

2.2 Initial Dosage

The starting dose of preservative-free morphine sulfate injection must be individualized.

•
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 preservative-free 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.
•
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.
•
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 (5.2)].
•
Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with preservative-free morphine sulfate injection. Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions (5)].

2.3 Dosage for Intravenous Administration

Adult Dosage: The initial dose of morphine should be 2 mg to 10 mg/70 kg of body weight, and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of preservative-free morphine sulfate injection.

2.4 Dosage for Epidural Administration

Adult Dosage: Initial injection of 5 mg in the lumbar region may provide satisfactory pain relief for up to 24 hours. If adequate pain relief is not achieved within one hour, careful administration of incremental doses of 1 to 2 mg at intervals sufficient to assess effectiveness may be given. Do not administer more than 10 mg per 24 hours.

2.5 Dosage for Intrathecal Administration

Adult Dosage: Intrathecal dosage is usually 1/10 that of epidural dosage. A single injection of 0.2 to 1 mg may provide satisfactory pain relief for up to 24 hours. (Caution: this is only 0.4 to 2 mL of the 5 mg/10 mL vial or 0.2 to 1 mL of the 10 mg/10 mL vial of preservative-free morphine sulfate injection).

•
Do not inject intrathecally more than 2 mL of the 5 mg/10 mL vial or 1 mL of the 10 mg/10 mL vial.
•
Repeated intrathecal injections of preservative-free morphine sulfate injection are not recommended. If pain recurs, consider alternative routes of administration.
•
A constant intravenous infusion of naloxone, 0.6 mg/hr, for 24 hours after intrathecal injection may be used to reduce the incidence of potential side effects.

2.6 Discontinuation of Preservative-Free Morphine Sulfate Injection

When a patient who has been treated with a regimen of opioid analgesics including preservative-free morphine sulfate injection regularly and may be physically-dependent or no longer requires therapy with preservative-free morphine sulfate injection, taper the dose gradually 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 preservative-free morphine sulfate injection in a physically-dependent patient [see Warnings and Precautions (5.16), Drug Abuse and Dependence (9.3)].
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