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Morphine (Morphine Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 

Limitations of Use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.

DOSAGE AND ADMINISTRATION

Initial Dosing

Morphine sulfate extended-release tablets should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions].  Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with morphine sulfate extended-release tablets [see Warnings and Precautions ].

Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions].

Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

Initiate treatment with morphine sulfate extended-release tablets with 15 mg tablets orally every 8 or 12 hours.

Use of Morphine Sulfate Extended-Release Tablets in Patients who are not Opioid Tolerant

The starting dose for patients, who are not opioid-tolerant, is morphine sulfate extended-release tablets 15 mg orally every 12 hours. Patients who are opioid-tolerant are those 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, or an equianalgesic dose of another opioid.

Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

Conversion from Other Oral Morphine to Morphine Sulfate Extended-Release Tablets

Patients receiving other oral morphine formulations may be converted to morphine sulfate extended-release tablets by administering one-half of the patient's 24-hour requirement as morphine sulfate extended-release tablets on an every-12-hour schedule or by administering one-third of the patient's daily requirement as morphine sulfate extended-release tablets on an every-8-hour schedule.

Conversion from Other Opioids to Morphine Sulfate Extended-Release Tablets

There are no established conversion ratios for conversion from other opioids to morphine sulfate extended-release tablets defined by clinical trials. Discontinue all other around-the-clock opioid drugs when morphine sulfate extended-release tablets therapy is initiated and initiate dosing using morphine sulfate extended-release tablets 15 mg orally every 8 to 12 hours.

It is safer to underestimate a patient’s 24-hour oral morphine requirements and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine requirements and manage an adverse reaction. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.

Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to morphine sulfate extended-release tablets, consider the following general points:

  • Parenteral to oral morphine ratio: Between 2 to 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of morphine that is approximately three times the previous daily parenteral morphine requirement is sufficient.
  • Other parenteral or oral non-morphine opioids to oral morphine sulfate: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.

Conversion from Methadone to Morphine Sulfate Extended-Release Tablets

Close monitoring is of particular importance when converting methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

Titration and Maintenance of Therapy

Individually titrate morphine sulfate extended-release tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving morphine sulfate extended-release tablets 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. 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. During chronic therapy periodically reassess the continued need for the use of opioid analgesics.

Patients who experience breakthrough pain may require a dose increase of morphine sulfate extended-release tablets, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the morphine sulfate extended-release tablets dose. Because steady-state plasma concentrations are approximated in 1 day, morphine sulfate extended-release tablets dosage adjustments may be done every 1 to 2 days.

If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of Morphine Sulfate Extended-Release Tablets

When the patient no longer requires therapy with morphine sulfate extended-release tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient.  Do not abruptly discontinue morphine sulfate extended-release tablets.

Administration of Morphine Sulfate Extended-Release Tablets

Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions ].

DOSAGE FORMS AND STRENGTHS

  • Morphine sulfate extended-release tablets 15 mg
    Round, blue-colored, film-coated tablets bearing the symbol ABG on one side and 15 on the other
  • Morphine sulfate extended-release tablets 30 mg
    Round, lavender-colored, film-coated tablets bearing the symbol ABG on one side and 30 on the other
  • Morphine sulfate extended-release tablets 60 mg
    Round, orange-colored, film-coated tablets bearing the symbol ABG on one side and 60 on the other
  • Morphine sulfate extended-release tablets 100 mg*
    Round, gray-colored, film-coated tablets bearing the symbol ABG on one side and 100 on the other
  • Morphine sulfate extended-release tablets 200 mg*
    Capsule-shaped, green-colored, film-coated tablets bearing the symbol ABG on one side and 200 on the other

*100 mg and 200 mg tablets are for use in opioid-tolerant patients only

HOW SUPPLIED/STORAGE AND HANDLING

Morphine Sulfate Extended-Release Tablets 15 mg are round, blue-colored, film-coated tablets bearing the symbol ABG on one side and 15 on the other. They are supplied as follows:

NDC 42858-801-01: opaque plastic bottles containing 100 tablets

Morphine Sulfate Extended-Release Tablets 30 mg are round, lavender-colored, film-coated tablets bearing the symbol ABG on one side and 30 on the other. They are supplied as follows:

NDC 42858-802-01: opaque plastic bottles containing 100 tablets

Morphine Sulfate Extended-Release Tablets 60 mg are round, orange-colored, film-coated tablets bearing the symbol ABG on one side and 60 on the other. They are supplied as follows:

NDC 42858-803-01: opaque plastic bottles containing 100 tablets

Morphine Sulfate Extended-Release Tablets 100 mg are round, gray-colored, film-coated tablets bearing the symbol ABG on one side and 100 on the other. They are supplied as follows:

NDC 42858-804-01: opaque plastic bottles containing 100 tablets

Morphine Sulfate Extended-Release Tablets 200 mg are capsule-shaped, green-colored, film-coated tablets bearing the symbol ABG on one side and 200 on the other. They are supplied as follows:

NDC 42858-805-01: opaque plastic bottles containing 100 tablets

Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F).

Dispense in a tight, light-resistant container.

CAUTION

DEA FORM REQUIRED

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