Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Status
Approved
Full Title
Phenytoin Sodium 100 mg Injection, USP 2 mL VialThese highlights do not include all the information needed to use PHENYTOIN SODIUM INJECTION safely and effectively. See full prescribing information for PHENYTOIN SODIUM INJECTION. PHENYTOIN Sodium Injection for intravenous or intramuscular use. Initial U.S. Approval: 1953WARNING: CARIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSIONSEE 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)
United States
Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.
