IMPORTANT RISK INFORMATION
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, andACCIDENTAL EXPOSURE
Morphine sulfate extended-release tablets contain morphine, an opioid agonist and Schedule IIcontrolled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient's risk for opioid abuse or addiction prior to prescribing morphine sulfate extended-release tablets. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving morphine sulfate extended-release tablets for signs of misuse, abuse, and addiction during treatment.
Life-Threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of morphine sulfate extended release tablets, even when the drug has been used as recommended and not misused or abused. Proper dosing and titration are essential and morphine sulfate extended-release tablets should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. 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, dissolving, or chewing the tablet can cause rapid release and absorption of a potentially fatal dose of morphine.
Accidental ingestion of morphine sulfate extended-release tablets, especially in children, can result in a fatal overdose of morphine.
- 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
- Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients.
- Monitor 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 for respiratory depression, particularly when initiating therapy and titrating with morphine sulfate extended-release tablets, as in these patients, even usual therapeutic doses of morphine sulfate may decrease respiratory drive to the point of apnea.
- 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 may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients.Avoid the use of morphine sulfate extended-release tablets in patients with circulatory shock.
- Use with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or in patients with preexisting respiratory depression.
- Morphine is an opioid agonist and is sought by drug abusers and people with addiction disorders and is subject to criminal diversion.
- Morphine sulfate 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 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.
- Use of a mixed opioid agonist/antagonist analgesics in patients who have received or are receiving morphine sulfate as they may precipitate withdrawal symptoms.
- Morphine sulfate may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
- Serious adverse reactions may include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension tachycardia, bradycardia, seizures, shock and anaphylaxis.
- The most common adverse effects are constipation, dizziness, sedation, nausea, vomiting, sweating, dysphoria and euphoric mood.
USE IN SPECIFIC POPULATIONS
- 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 extended-release 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.
Gray, Round Convex Shaped Tablet
Debossed M in a box on one side and debossed "100" on the other side
100 U.D. ten 2x5 blister cards
For additional information on Morphine Sulfate Extended-Release Tablets, CII 100 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.