Label: FOSPHENYTOIN SODIUM injection, solution

  • NDC Code(s): 25021-798-02, 25021-798-10
  • Packager: Sagent Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 18, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use FOSPHENYTOIN SODIUM INJECTION safely and effectively. See full prescribing information for FOSPHENYTOIN SODIUM ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES

    The rate of intravenous fosphenytoin sodium injection administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute in adults and 2 mg PE/kg/min (or 150 mg PE/min, 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 fosphenytoin 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 (2.3, 2.4) and Warnings and Precautions (5.2)].

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  • 1 INDICATIONS AND USAGE
    Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions to Avoid Dosing Errors - Use caution when administering fosphenytoin sodium injection because of the risk of dosing errors [see Warnings and Precautions ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Fosphenytoin sodium Injection, USP is a clear, colorless to pale yellow solution available as 50 mg phenytoin sodium equivalents (PE) per mL in: 10 mL single-dose injection vials, each ...
  • 4 CONTRAINDICATIONS
    Fosphenytoin sodium is contraindicated in patients with: A history of hypersensitivity to fosphenytoin sodium injection or its inactive ingredients, or to phenytoin or other hydantoins [see ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Dosing Errors - Phenytoin Sodium Equivalents (PE) Do not confuse the amount of drug to be given in PE with the concentration of the drug in the vial. Doses of fosphenytoin sodium are ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described elsewhere in the labeling: Cardiovascular Risk Associated with Rapid Infusion [see Warnings and Precautions (5.2)] Withdrawal Precipitated ...
  • 7 DRUG INTERACTIONS
    Fosphenytoin is extensively bound to human plasma proteins. Drugs highly bound to albumin could increase the unbound fraction of fosphenytoin. Although, it is unknown whether this could result in ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as fosphenytoin ...
  • 10 OVERDOSAGE
    Nausea, vomiting, lethargy, tachycardia, bradycardia, asystole, cardiac arrest, hypotension, syncope, hypocalcemia, metabolic acidosis, and death have been reported in cases of overdosage with ...
  • 11 DESCRIPTION
    Fosphenytoin sodium injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium USP is equivalent to 1 mg phenytoin ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Fosphenytoin is a prodrug of phenytoin and accordingly, its anticonvulsant effects are attributable to phenytoin. The precise mechanism by which phenytoin exerts its ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - [see Warnings and Precautions (5.9)] The carcinogenic potential of fosphenytoin has not been assessed. In ...
  • 14 CLINICAL STUDIES
    Infusion tolerance was evaluated in clinical studies. One double-blind study assessed infusion-site tolerance of equivalent loading doses (15 to 20 mg PE/kg) of fosphenytoin sodium infused at 150 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Fosphenytoin Sodium Injection, USP is a clear, colorless to pale yellow solution supplied as follows: NDCFosphenytoin Sodium Injection, USPPackage Factor - (50 mg PE ...
  • 17 PATIENT COUNSELING INFORMATION
    Cardiovascular Risk Associated with Rapid Infusion - Inform patients that rapid intravenous administration of fosphenytoin sodium increases the risk of adverse cardiovascular reactions ...
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
    NDC 25021-798-02 - Rx only - Fosphenytoin Sodium Injection, USP - 100 mg PE per 2 mL - (50 mg PE per mL) (PE=phenytoin sodium equivalents) For Intramuscular or Intravenous Use - 2 mL Single-Dose ...
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
    NDC 25021-798-10 - Rx only - Fosphenytoin Sodium Injection, USP - 500 mg PE per 10 mL - (50 mg PE per mL) (PE=phenytoin sodium equivalents) For Intramuscular or Intravenous Use - 10 mL Single-Dose ...
  • INGREDIENTS AND APPEARANCE
    Product Information