SPL Set ID: 2cdc1905-8f45-1275-e063-6394a90a2ab7

Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-Diphenylhydantoin sodium salt, having the following structural formula: Each 200 mg or 300 mg PHENYTEK ® capsule (extended phenytoin sodium capsule, USP) for oral administration contains 200 mg or 300 mg phenytoin sodium, USP. Also contains colloidal silicon dioxide, FD&C Blue No. 1, gelatin, hydroxyethyl cellulose, magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and titanium dioxide. In addition, the imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to prompt phenytoin sodium capsules with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. Meets USP Dissolution Test 3.