phenytoin sodium

FDA Drug Profile — Phenytek, PHENYTOIN SODIUM, phenytoin sodium

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 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)