Phenytoin

FDA Drug Profile — Phenytoin, Phenytoin Infatabs, Dilantin-125, Dilantin Infatabs

Drug Details

Generic Name
Phenytoin
Brand Names
Phenytoin, Phenytoin Infatabs, Dilantin-125, Dilantin Infatabs
Application Number
NDA008762
Sponsor
RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA
NDC Codes
21
Dosage Forms
POWDER, SUSPENSION, TABLET, CHEWABLE
Routes
ORAL
Active Ingredients
PHENYTOIN

Indications and Usage

1 INDICATIONS AND USAGE Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous phenytoin can also be substituted, as short-term use, for oral phenytoin. Parenteral phenytoin should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.1, 2.3) and Warnings and Precautions (5.1)]. Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Intravenous phenytoin can also be substituted, as short-term use, for oral phenytoin. Parenteral phenytoin should be used only when oral phenytoin administration is not possible. (1)