Oramorph SR

OramorphSR

Oramorph SR (morphine sulfate) Sustained Release Tablets are indicated for the relief of pain in adult patients who require opioid analgesics for more than a few days.

OramorphSR-full-prescribing-information.pdf

Important Safety Information:

  • Oramorph SR is a sustained release dosage form. Patients must be instructed to swallow the tablet whole; the tablet should not be broken in half, nor should it be crushed or chewed. The sustained release of morphine from Oramorph SR should be taken into consideration in the event of adverse reactions or overdosage.
  • Serious adverse reactions caused by morphine, which can be fatal, include respiratory depression, circulatory depression, apnea, shock, and cardiac arrest.
  • Oramorph SR should be used with extreme caution in any patient who may have decreased respiratory reserve. Respiratory depression is the chief hazard of all morphine preparations.
  • The most common adverse reactions reported with administration of Oramorph SR include constipation, nausea, vomiting, lightheadedness, dizziness, sedation, dysphoria, euphoria, and sweating.
  • Oramorph SR is contraindicated in patients with respiratory depression in the absence of resuscitative equipment, in patients with acute or severe bronchial asthma and in patients with known hypersensitivity to morphine. Oramorph SR is also contraindicated in any patient who has or is suspected of having a paralytic ileus.
  • Morphine sulfate is a Schedule II controlled substance. Morphine is the most commonly cited prototype for narcotic substances that possess an addiction-forming or addiction-sustaining liability. A patient may be at risk for developing dependence to morphine if used improperly or for overly long periods of time. Oramorph SR should be used with caution in individuals with a prior history of substance abuse or dependence.
  • Oramorph SR should be used with extreme caution in patients with increased intracranial pressure or those with a head injury.
  • The clearance of morphine or its metabolites may be reduced in patients with hepatic or renal dysfunction. Pharmacodynamic changes in these patients should be considered when adjusting the dose and dosing intervals.
  • The depressant effects of morphine are potentiated by the presence of other CNS depressants such as alcohol, sedatives, antihistamines, or psychotropic drugs. Opioid receptor agonist/antagonist analgesics should NOT be administered to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic.
  • There has been no systematic evaluation of Oramorph SR as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using a sustained release morphine, it is ordinarily advisable to begin treatment using an immediate release formulation.
  • For additional Important Safety Information, please see full Prescribing Information