Saturday, May 24, 2008

DepoDur Warnings

I was preparing to submit a pharmacy request to add DepoDur (liposomally encapsulated epidural morphine) to our formulary what I ran across this nugget:

FDA Warns of Settings That Increase Risk for Respiratory Depression From Morphine Sulfate Extended-Release Liposome Injection (DepoDur)

On December 14, 2007, the FDA approved safety labeling revisions for morphine sulfate extended-release liposome epidural injection (DepoDur; Skye Pharma Inc) to warn of settings associated with an increased risk for respiratory depression.

Although the formulation is intended for administration by the epidural route only, postmarketing reports have included cases of intrathecal use. In all cases, signs of prolonged respiratory depression required use of a narcotic antagonist (naloxone) or ventilatory support.

Because a breached dural membrane can lead to intrathecal leakage, particularly when the epidural drug is administered in a bolus, vigilant monitoring of respiratory function for a prolonged period (48 hours) is advised when extended-release morphine sulfate liposome injection is administered after a recent dural puncture. Provision should be made for emergency ventilation to minimize the risk for serious respiratory depression.

Subarachnoid puncture during epidural administration of the product has also been linked to cases of prolonged and serious respiratory depression or apnea, occurring within 12 hours of injection and after apparent recovery from anesthesia. Respiratory depression can be successfully treated with a naloxone bolus or, more commonly, a naloxone infusion; intubation and mechanical ventilation may be necessary in some cases.

Morphine sulfate extended-release liposome injection is indicated for single-dose epidural administration at the lumbar level to treat postoperative pain; it is given before surgery or after clamping the umbilical cord during cesarean delivery. The injection is not intended for intrathecal, intravenous, or intramuscular administration.

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