A Timely Transformation for Pralidoxime Antidote

Pralidoxime (Protopam, Wyeth, Baxter), an antidote for organophosphate poisoning from insecticides, is also a potential antidote in the event of mass casualties resulting from nerve agents. The IV form, which is easy to administer and titrate, is preferable in emergency departments and intensive care units. Researchers from Ohio State University tested a method to convert the intramuscular (IM) formulation to an IV form.

The researchers were concerned to find only 36 g of IV pralidoxime available for the 1.1 million people of Franklin County, Ohio—less than 4 g per hospital. They say that a national purchasing restriction of Protopam, the only formulation marketed for IV use, is partly responsible for the low stockpile. However, the study also revealed the availability of a large supply of supply of IM pralidoxime (4,398 g), mostly outside of hospital settings.

The authors injected five autoinjectors, each containing 2 ml of a 300-mg/L solution of pralidoxime, into sterile empty, vented 30-ml vials. The resulting 3-g (10-ml) pralidoxime contents of each vented vial were used to prepare two concentrations diluted for IV administration. The solution was found to be stable under various conditions at temperatures ranging from -20° to 50°C for up to 28 days.
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For many years, Wyeth had been the sole manufacturer of Protopam. In November 2003, Wyeth stated that the product was out of stock. This product line had been sold to Baxter, Inc., in August 2003.