البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)
Lake Erie Medical DBA Quality Care Products LLC
PHENYTOIN SODIUM
PHENYTOIN SODIUM 100 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
DILANTIN- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- DILANTIN (EXTENDED PHENYTOIN SODIUM CAPSULES, USP) DESCRIPTION Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2, 4-imidazolidinedione, having the following structural formula: Each 30 mg Dilantin- (_extended phenytoin sodium capsule_, USP)-contains 30 mg phenytoin sodium, USP. Also contains lactose monohydrate, NF; confectioner's sugar, NF; talc, USP; and magnesium stearate, NF. The capsule shell cap and body components contain titanium dioxide (cap and body); gelatin (cap and body); D&C yellow No. 10 (cap); FD&C red No. 3 (cap). 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_, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. Each 100 mg Dilantin- 100 mg _(extended phenytoin sodium capsule, USP)_ -contains 100 mg phenytoin sodium. Also contains lactose monohydrate, NF; confectioner's sugar, NF; talc, USP; and magnesium stearate, NF. The capsule body contains titanium dioxide, USP and gelatin, NF. The capsule cap contains FD&C red No. 28; FD&C yellow No. 6; and gelatin NF. 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_, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Phenytoin is an antiepileptic drug which can be useful in the treatment of epilepsy. The primary site of action appears to be the _motor cortex_ where spread of seizure activity is inhibited. Possibly by promoting sodium efflux from neurons, phenytoin tends to _stabilize_ the threshold against hyperexcitability caused by e اقرأ الوثيقة كاملة