Oramorph : Oramorph SR

The Oramorph SR Difference
Innovative hydrophilic matrix provides predictable release of morphine¹

Smooth Plasma Levels
Oramorph SR offers smooth, predictable levels of morphine

Up to 12-hour duration of action²

Hydrophilic matrix release delivers predictable plasma concentration levels of morphine³

Fewer peaks and troughs in plasma morphine levels may have a therapeutic advantage in controlling pain²

Reduced fluctuations between maximum and minimum morphine levels

Multiple-dose, two-way crossover study in healthy men (N=24) comparing sustained-release morphine tablets (SR) with immediate-release morphine oral solution (IR). Patients were dosed for 3 days with 30 mg SR q12h or 10 mg IR q4h. Data represent plasma morphine levels from 48-60 hours.

Ongoing Relief
Oramorph SR delivers proven efficacy, consistent pain control⁴
In a double-blind study in 34 patients with moderate-to-severe cancer pain:

No patients stopped therapy due to inadequate pain control

<20% of patients experienced breakthrough pain during dosing

Equivalent efficacy to IR oral morphine

91% of patients stayed on Oramorph SR after study completion

Equivalent efficacy to immediate-release oral morphine

Double-blind, multiple-dose, placebo-controlled crossover study in patients with moderate-to-severe cancer pain (N=34). Patients currently receiving at least 60 mg/day morphine were randomized to SR morphine q12h or IR morphine q4h for 2 days. Patients then crossed over to the alternative therapy for 3 days. Data represent pain scores on days 2 and 5.

References: 1. Amabile CM, Bowman BJ. Overview of oral modified-release opioid products for the management of chronic pain. Ann Pharmacother. 2006;40:1327-1335. 2. Oramorph SR (morphine sulfate) package insert. Rev. 02-2006. 3. Schobelock MJ, et al. Multiple-dose pharmacokinetic evaluation of two formulations of sustained-release morphine sulfate tablets. Curr Ther Res. 1995;56:1009-1021. 4. Finn JW, et al. Placebo-blinded study of morphine sulfate sustained-release tablets and immediate-release morphine sulfate solution in outpatients with chronic pain due to advanced cancer. J Clin Oncol. 1993;11:967-972.

Important Safety Information

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.

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.

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