Morphine Sulfate

MORPHINE SULFATE- morphine sulfate suppository
Padagis US LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

1 INDICATIONS AND USAGE

Morphine sulfate suppositories are indicated for the management of acute and chronic pain severe enough to require and opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve morphine sulfate suppositories 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

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Morphine sulfate suppositories are available in four strengths: 5 mg per suppository, 10 mg per suppository, 20 mg per suppository, and 30 mg per suppository.

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 (5.1)].

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with morphine sulfate suppositories and adjust the dosage accordingly [see Warnings and Precautions (5.2) ].

2.2 Initial Dosage

Initiating Treatment with Morphine Sulfate Suppositories

Initiate treatment with morphine sulfate suppositories in a dosing range of 10 – 20 mg, rectally, every 4 hours.

Conversion from Other Opioids to Morphine Sulfate Suppositories

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised with determining the total daily dosage of morphine sulfate suppositories. It is safer to underestimate a patient’s 24-hour morphine sulfate dosage than to overestimate the 24-hour dosage and manage and adverse reaction due to overdose.

Conversion from Morphine Sulfate Suppositories to Extended-Release Morphine

The relative bioavailability of morphine sulfate suppositories compared to extended-release morphine is unknown, so conversion to extended-release drug product must be accompanied by close observation for signs of excessive sedation and respiratory depression.

2.3 Titration and Maintenance of Therapy

Individually titrate morphine sulfate suppositories to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving morphine sulfate suppositories to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the morphine sulfate suppositories dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

2.4 Discontinuation of Morphine Sulfate Suppositories

When a patient who has been taking morphine sulfate suppositories regularly and may be physically dependent no longer requires therapy with morphine sulfate suppositories, 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 suppositories in a physically-dependent patient [see Warnings and Precautions (5.12), Drug Abuse and Dependence (9.3)].

3 DOSAGE FORMS AND STRENGTHS

Morphine Sulfate Suppositories are available in four strengths:

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5 mg per suppository

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10 mg per suppository

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20 mg per suppository

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30 mg per suppository

4 CONTRAINDICATIONS

Morphine sulfate suppositories are contraindicated in patients with:

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Significant respiratory depression [see Warnings and Precautions (5.2)]

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Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.5)]

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Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.6), Drug Interactions (7)]

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Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.10)]

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Hypersensitivity to morphine (e.g., anaphylaxis) [see Adverse Reactions (6)]