INFUMORPH (Preservative-free Morphine Sulfate Sterile Solution): US FDA label indications

Indications and usage (label excerpt)

INDICATIONS AND USAGE INFUMORPH (Preservative-free Morphine Sulfate Sterile Solution) is indicated only for intrathecal or epidural infusion in the treatment of intractable chronic pain. It was developed for use in continuous microinfusion devices and may require dilution before use as dictated by the characteristics of the device and the dosage requirements of the individual patient. INFUMORPH IS NOT RECOMMENDED FOR SINGLE-DOSE INTRAVENOUS, INTRAMUSCULAR OR SUBCUTANEOUS ADMINISTRATION DUE TO THE VERY LARGE AMOUNT OF MORPHINE IN THE AMPUL AND THE ASSOCIATED RISK OF OVERDOSAGE.

Warnings (label excerpt)

WARNINGS Morphine sulfate may be habit forming. Overdoses may cause respiratory depression, coma, and death. THIS PRODUCT WAS DEVELOPED FOR USE (AFTER APPROPRIATE DILUTION, IF NECESSARY) IN CONTINUOUS MICROINFUSION DEVICES FOR INTRATHECAL OR EPIDURAL INFUSION OF NARCOTICS TO CONTROL SEVERE CANCER PAIN. CHRONIC NEURAXIAL OPIOID ANALGESIA IS APPROPRIATE ONLY WHEN LESS INVASIVE MEANS OF CONTROLLING PAIN HAVE FAILED AND SHOULD ONLY BE UNDERTAKEN BY THOSE WHO ARE EXPERIENCED IN APPLYING THIS TREATMENT IN A SETTING WHERE ITS COMPLICATIONS CAN BE ADEQUATELY MANAGED. BECAUSE OF THE RISK OF SEVERE ADVERSE EFFECTS, PATIENTS MUST BE OBSERVED IN A FULLY EQUIPPED AND STAFFED ENVIRONMENT FOR AT LEAST 24 HOURS AFTER THE INITIAL (SINGLE) TEST DOSE AND, AS APPROPRIATE, FOR THE FIRST SEVERAL DAYS AFTER CATHETER IMPLANTATION. THE FACILITY MUST BE EQUIPPED TO RESUSCITATE PATIENTS WITH SEVERE OPIATE OVERDOSAGE, AND THE PERSONNEL MUST BE FAMILIAR WITH THE USE AND LIMITATIONS OF SPECIFIC NARCOTIC ANTAGONISTS…

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