Boxed Warning about Tissue Injury with IV Promethazine

FDA is requiring that promethazine hydrochloride injection products carry a boxed warning to communicate more strongly about the danger of giving the drug intravenously. The warning states that intra-arterial and subcutaneous administration of promethazine are contraindicated.

Promethazine is used as an antihistamine, a sedative and an antiemetic. Giving promethazine intravenously can result in severe tissue injury, including gangrene, which may require amputation. Because of this risk, the preferred route of administration is deep intramuscular injection.

If IV administration of promethazine is required, a maximum concentration of 25 mg/mL should be administered at a maximum rate of 25 mg/minute, through the tubing of an infusion set known to be functioning properly. The 50 mg/mL concentration should be used only for deep intramuscular injection.

Healthcare professionals should be alert to signs and symptoms of potential tissue injury, such as burning or pain at the administration site, phlebitis, swelling, and blistering. They should stop giving the drug immediately if a patient complains of pain. They should also tell patients receiving IV promethazine that side effects may occur immediately or develop hours to days after administration of the drug.

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