Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)
NCS HealthCare of KY, Inc dba Vangard Labs
PHENYTOIN SODIUM
PHENYTOIN SODIUM 100 mg
ORAL
PRESCRIPTION DRUG
Extended phenytoin sodium capsules 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). Extended phenytoin sodium capsules are contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.
Extended Phenytoin Sodium Capsules, USP are available containing phenytoin sodium equivalent to 100 mg of phenytoin, USP. The 100 mg capsule is a hard-shell gelatin capsule with a light lavender opaque cap and white opaque body filled with one white to off-white capsule-shaped tablet. The capsule is axially printed with MYLAN over 1560 in black ink on both the cap and body. They are available as follows: NDC 0615-1343-39 blistercards of 30 capsules NDC 0615-1343-31 blistercards of 31 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. U.S. Patent No. 6,274,168 U.S. Patent No. 6,620,432 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED NOVEMBER 2009 PHNY:R10
Abbreviated New Drug Application
PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- EXTENDED PHENYTOIN SODIUM CAPS 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 5,5-Diphenylhydantoin sodium salt, having a molecular weight of 274.25 and having the following structural formula and molecular formula: C H N NaO Each extended phenytoin sodium capsule, USP, for oral administration, contains 100 mg phenytoin sodium, USP. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, hydroxyethyl cellulose, magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. In addition, each of the empty gelatin capsules contains the following: D&C Red No. 28, D&C Red No. 33, FD&C Blue No. 1, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains the following: 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, USP with a rapid rate of absorption with peak blood concentration expected in 11⁄2 to 3 hours. Extended phenytoin sodium capsules, USP 100 mg meet _USP Dissolution Test 2._ 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 poten Perskaitykite visą dokumentą