Risk of severe tissue injury spurs FDA warning regarding injectable promethazine

FDA is alerting clinicians of labeling updates intended to further reduce risk of severe chemical irritation and tissue damage from IV administration of promethazine HCl injection. The agency recommends deep IM administration of the drug instead of IV. If IM injection isn’t possible, promethazine HCl can be given IV only after dilution, as recommended, through an IV catheter inserted in a large vein, preferably a central venous catheter. The drug shouldn’t be mixed with other drugs or diluted with solutions other than 0.9% NaCl and is contraindicated for IV use at concentrations >1 mg/mL.