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Morphine sulfate extended-release tablets, CII 200 mg

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.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of 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.

IMPORTANT RISK INFORMATION

WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORYDEPRESSION; ACCIDENTAL INGESTION; and NEONATAL OPIOID WITHDRAWAL SYNDROME 

Addiction, Abuse, and Misuse 

Morphine sulfate extended-release tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing morphine sulfate extended-release tablets, and monitor all patients regularly for the development of these behaviors or conditions. 

Life-Threatening Respiratory Depression 

Serious, life-threatening, or fatal respiratory depression may occur with use of morphine sulfate extended-release tablets. Monitor for respiratory depression, especially during initiation of morphine sulfate extended-release tablets or following a dose increase. Instruct patients to swallow morphine sulfate extended-release tablets whole; crushing, chewing, or dissolving morphine sulfate extended-release tablets can cause rapid release and absorption of a potentially fatal dose of morphine. 

Accidental Ingestion 

Accidental ingestion of even one dose of morphine sulfate extended-release tablets, especially by children, can result in a fatal overdose of morphine. 

Neonatal Opioid Withdrawal Syndrome 

Prolonged use of morphine sulfate extended-release tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

CONTRAINDICATIONS

  • Morphine sulfate extended-release 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

    WARNINGS AND PRECAUTIONS

    • Morphine sulfate extended-release tablets contain morphine, a Schedule II controlled substance. As an opioid, morphine sulfate extended-release tablets expose users to the risks of addiction, abuse, and misuse. As modified-release products such as morphine sulfate extended-release tablets deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of morphine present.
    • Serious, life-threatening, or fatal respiratory depression has been reported with the use of modified-release opioids, even when used as recommended. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of morphine sulfate extended-release tablets, the risk is greatest during the initiation of therapy or following a dose increase. Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. In patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression, morphine sulfate extended-release tablets may decrease respiratory drive to the point of apnea, particularly when initiating therapy and titrating with morphine sulfate extended-release tablets, even at usual therapeutic doses.
    • Hypotension, and profound sedation, coma or respiratory depression may result if morphine sulfate extended-release tablets are used concomitantly with other CNS depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, muscle relaxants, other opioids).
    • Morphine sulfate extended-release tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised.
    • Patients with brain tumors or increased intracranial pressure are susceptible to the intracranial effects of CO2 retention. Morphine sulfate extended-release tablets may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of morphine sulfate extended-release tablets in patients with impaired consciousness or coma.
    • Avoid the use of morphine sulfate extended-release tablets in patients with GI obstruction. Morphine sulfate extended-release tablets may cause spasm of the sphincter of Oddi.  Opioids may cause increases in the serum amylase.
    • Morphine may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings.
    • Avoid use of  mixed opioid agonist/antagonist analgesics in patients who have received or are receiving  morphine sulfate extended-release tablets, as they may precipitate withdrawal symptoms.
    • Morphine sulfate extended-release tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. 

    ADVERSE REACTIONS

    • Serious adverse reactions may include addiction, abuse, and misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, interactions with other CNS depressants, hypotensive effect, gastrointestinal effects, seizures, apnea, respiratory arrest, circulatory depression, hypotension tachycardia, bradycardia, shock and anaphylaxis.
    • The most common adverse effects are constipation, dizziness, sedation, nausea, vomiting, sweating, dysphoria and euphoric mood.

    USE IN SPECIFIC POPULATIONS

    • Pregnancy: Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome, which can be life-threatening. Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. 
    • Breastfeeding: Morphine is excreted in breast milk. Withdrawal signs can occur in breastfeeding infants when maternal administration of morphine is stopped.
    • Pediatrics: The safety and effectiveness in pediatric patients below the age of 18 have not been established
    • Elderly: 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.

      Description Green, capsule shaped convex tablet
      Dosage Strength 200 mg
      Compares To MS Contin®
      Identification Code Debossed M in a box on one side and debossed "200" on the other side
      Rating AB

      Order Information

      NDC # Package Size Case Quantity
      0406-8320-01 100's 12

      For additional information on Morphine sulfate extended-release tablets, CII 200 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.

      MS Contin is a registered trademark of Purdue Pharma L.P.