Morphine Sulfate (Extended Release)


Morphine Sulfate (Extended Release)


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What is Morphine sulfate (Extended release)?

Morphine sulfate (Extended release) 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.


Morphine sulfate  tablets are indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Morphine sulfate extended-release 100 mg and 200 mg tablets are only for patients in whom tolerance to an opioid of comparable potency is established.


  • Morphine sulfate  tablets are contraindicated in patients with:
    • Significant respiratory depression.
    • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
    • Known or suspected paralytic ileus.
    • Hypersensitivity (e.g., anaphylaxis) to morphine.

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 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  tablets are not indicated as an as-needed (prn) analgesic.

Dosage and administration OF Morphine Sulfate (Extended Release)

Initial Dosing
Morphine sulfate  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. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with 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.

Use Of Morphine Sulfate  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 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 extendedrelease 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 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 Tablets
When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to morphine sulfate  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.


  • Pregnancy and breast feeding: Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Chronic maternal use of morphine during pregnancy can affect the fetus with subsequent withdrawal signs.
  • Opioids cross the placenta. Morphine sulfate  tablets are not recommended for use in women during and immediately prior to labor. Infants born to mothers who have taken opioids chronically may exhibit neonatal withdrawal syndrome.
  • Breast Feeding: Morphine is excreted in breast milk. Withdrawal signs can occur in breast-feeding infants when maternal administration of morphine is stopped.
  • The safety and effectiveness in pediatric patients below the age of 18 have not been established
  • Morphine Sulfate dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Side Effect of Morphine Sulfate (Extended Release)

The following serious adverse reactions are described elsewhere in the labeling:

Addiction, Abuse, and Misuse
Life-Threatening Respiratory Depression
Neonatal Opioid Withdrawal Syndrome
Interactions with Other CNS Depressants
Hypotensive Effect
Gastrointestinal Effects

Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Morphine sulfate  tablets may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock.

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