Fosphenytoin sodium

FDA Drug Profile — Fosphenytoin sodium

Drug Details

Generic Name
Fosphenytoin sodium
Brand Names
Fosphenytoin sodium
Application Number
ANDA214926
Sponsor
GLENMARK PHARMACEUTICALS INC., USA
NDC Codes
6
Dosage Forms
INJECTION, SOLUTION, POWDER
Routes
INTRAMUSCULAR, INTRAVENOUS
Active Ingredients
FOSPHENYTOIN SODIUM

Indications and Usage

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 sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ] . Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, as short-term use, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible.