Black Box Warning
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION The rate of intravenous Phenytoin Sodium Injection administration should not exceed 50 mg per minute in adults and 1 to 3 mg/kg/min (or 50 mg per minute, whichever is slower) in pediatric patients because of the risk of severe hypotension and cardiac arrhythmias. Careful cardiac monitoring is needed during and after administering intravenous Phenytoin Sodium Injection. Although the risk of cardiovascular toxicity increases with infusion rates above the recommended infusion rate, these events have also been reported at or below the recommended infusion rate. Reduction in rate of administration or discontinuation of dosing may be needed [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ] . W ARN ING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION S ee full prescribing information for complete boxed warning . The rate of intravenous Phenytoin Sodium Injection administration should not exceed 50 mg per minute in adults and 1 to 3 mg/kg/min (or 50 mg per minute, whichever is slower) in pediatric patients because of the risk of severe hypotension and cardiac arrhythmias. Careful cardiac monitoring is needed during and after administering intravenous Phenytoin Sodium Injection. Reduction in rate of administration or discontinuation of dosing may be needed ( 2.1 , 5.1 ).
What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Phenytoin Sodium.