DepoDur found to be innovative option for postoperative p...( Dur TM into the thoracic epidural spac...),Health

The FDA approval of DepoDur^TM was based on clinical data showing significantly improved outcomes in 876 patients undergoing major surgical procedures such as hip replacement, lower abdominal surgery and elective Caesarean section. In clinical trials, patients given DepoDur^TM demonstrated lower pain intensity scores and reduced need for rescue medication. In these trials, efficacy was assessed for at least 48 hours and safety was assessed for up to 30 days after DepoDur^TM administration.

As with all opioids, the chief hazard of morphine sulfate is respiratory depression, especially in elderly and debilitated patients and in those with compromised respiratory function; therefore, patients must be monitored for a least 48 hours and the facility must be equipped to resuscitate patients. No other medication should be administered in the epidural space for at least 48 hours. DepoDur^TM is contraindicated in patients with known hypersensitivity to morphine or the product's components, and in those patients with respiratory depression, acute or severe bronchial asthma, upper airway obstruction, those who have or are suspected of having paralytic ileus, head injury or increased intracranial pressure and those who are in circulatory shock. Any contraindications for an epidural injection preclude the administration of DepoDur^TM. Patients with depleted blood volume receiving DepoDur^TM may experience severe hypotension. The most common adverse events reported in clinical studies (>10%) were: decreased oxygen saturation, hypotension, urinary retention, vomiting, constipation, nausea, pruritus, pyrexia, anemia, headache, and dizziness. DepoDur^TM is a Schedule II controlled substance and is subject to abuse and diversion.

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Contact: Wendy Lu
wendy_lu@nyc.cohnwolfe.com
212-798-9839
Cohn & Wolfe
26-Oct-2004</sup>