Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
Phenytoin Sodium (UNII: 4182431BJH) (Phenytoin - UNII:6158TKW0C5)
Contract Pharmacy Services-PA
Phenytoin Sodium
Phenytoin Sodium 100 mg
ORAL
PRESCRIPTION DRUG
Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY ). Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.
Extended Phenytoin Sodium Capsules USP, 100 mg are hard gelatin capsules No. 3 with an opaque orange body and cap, imprinted "TARO PHN 100" in black ink. They are available in: Blisters of 30…………..…NDC 67046-585-30 Blisters of 60……….….....NDC 67046-585-60 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.
Abbreviated New Drug Application
PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE CONTRACT PHARMACY SERVICES-PA ---------- EXTENDED PHENYTOIN SODIUM CAPSULES USP, 100 MG RX ONLY DESCRIPTION Phenytoin sodium is an antiepileptic drug. 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 Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product _in vivo_ performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours. CLINICAL PHARMACOLOGY Phenytoin is an antiepileptic drug which can be used 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 excessive stimulation or environmental changes capable of reducing membrane sodium gradient. This includes the reduction of posttetanic potentiation at synapses. Loss of posttetanic potentiation prevents cortical seizure foci from detonating adjacent cortical areas. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonic-clonic (grand mal) seizures. The plasma half-life in man after oral administration of phenytoin averages 22 hours, with a range of 7 to 42 hours. Steady-state therapeutic levels are achieved at least 7 to 10 days (5-7 half-lives) after initiation of therapy with recommended doses of 300 mg/day. When serum level determinations are necessary, they should be o Đọc toàn bộ tài liệu