phenytoin sodium

FDA Drug Profile — Phenytek, phenytoin sodium, PHENYTOIN SODIUM

phenytoin sodium is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including Phenytek, phenytoin sodium, PHENYTOIN SODIUM. Available dosage forms: capsule, extended release, injection.

Drug Details

Generic Name
phenytoin sodium
Brand Names
Phenytek, phenytoin sodium, PHENYTOIN SODIUM
Application Number
ANDA040298
Sponsor
Mylan Pharmaceuticals Inc.
NDC Codes
4
Dosage Forms
CAPSULE, EXTENDED RELEASE, INJECTION
Routes
ORAL, INTRAMUSCULAR, INTRAVENOUS
Active Ingredients
PHENYTOIN 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.