If clinically advisable, patients receiving morphine sulfate extended-release tablets or their caregivers should be given the following information by the physician, nurse, or pharmacist:

  1. Patients should be advised that morphine sulfate extended-release tablets contain morphine and should be taken only as directed.
  2. Patients should be advised that morphine sulfate extended-release tablets were designed to work properly only if swallowed whole. Morphine sulfate extended-release tablets will release all of their morphine if split, divided, broken, chewed, dissolved, or crushed resulting in the risk of a fatal overdose.
  3. Patients should be advised not to change the dose of morphine sulfate extended-release tablets without consulting their physician.
  4. Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.
  5. Morphine sulfate extended-release tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients started on morphine sulfate extended-release tablets or whose dose has been changed should refrain from dangerous activity until it is established that they are not adversely affected.
  6. Morphine sulfate extended-release tablets should not be taken with alcohol or other CNS depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician because dangerous additive effects may occur resulting in serious injury or death.
  7. Women of childbearing potential who become or are planning to become pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.
  8. Patients should be advised that if they have been receiving treatment with morphine sulfate extended-release tablets for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the morphine sulfate extended-release tablets dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.
  9. Morphine sulfate extended-release 100 mg and 200 mg tablets are for use only in opioid-tolerant patients requiring daily morphine equivalent dosages of 200 mg or more for the 100 mg tablet and 400 mg or more for the 200 mg tablet. Special care must be taken to avoid accidental ingestion or the use by individuals (including children) other than the patient for whom it was originally prescribed, as such unsupervised use may have severe, even fatal, consequences.
  10. Patients should be advised that morphine sulfate extended-release tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
  11. Patients should be advised that they may pass empty matrix "ghosts" (tablets) via colostomy or in the stool, and that this is of no concern since the active medication has already been absorbed.
  12. Patients should be instructed to keep morphine sulfate extended-release tablets in a secure place out of the reach of children. When morphine sulfate extended-release tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet.