PHENYLEX-100 Injection

PHENYLEX-100 Injection contains Phenytoin Sodium USP, an anticonvulsant formulation intended for parenteral administration. The product is presented in 5 × 2 mL ampoules, with the product artwork specifying IV/IM use.

Phenytoin is a hydantoin anticonvulsant that helps control abnormal electrical activity in the brain. Phenytoin formulations are used in the management of tonic-clonic seizures and focal/psychomotor seizures, and parenteral phenytoin has an established role in hospital settings where intravenous anticonvulsant therapy is required.

Injectable phenytoin may be used for loading or maintenance therapy in selected clinical situations, including seizure management associated with neurosurgical care. Treatment decisions depend on the patient's seizure type, clinical condition, previous anticonvulsant therapy and serum phenytoin concentrations where monitoring is appropriate.

Because intravenous phenytoin can produce significant cardiovascular and respiratory adverse effects, administration requires appropriate clinical monitoring. Official labeling recommends controlled administration rates and careful cardiac and respiratory monitoring during and after IV administration.