国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)
Cardinal Health
PHENYTOIN SODIUM
PHENYTOIN SODIUM 100 mg
ORAL
PRESCRIPTION DRUG
Extended phenytoin sodium capsules, USP are indicated for the control of generalized tonic-clonic (grand mal) and 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 with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins. Coadministration of phenytoin is contraindicated with delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.
Extended Phenytoin Sodium Capsules, USP are available containing 100 mg of phenytoin sodium, 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: Overbagged with 10 capsules per bag, NDC 55154-5496-0. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE Cardinal Health ---------- MEDICATION GUIDE EXTENDED PHENYTOIN SODIUM CAPSULES, USP (fen′ i toin soe′ dee um) 100 mg Read this Medication Guide before you start taking extended phenytoin sodium capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about extended phenytoin sodium capsules, ask your healthcare provider or pharmacist. What is the most important information I should know about extended phenytoin sodium capsules? Do not stop taking extended phenytoin sodium capsules without first talking to your healthcare provider. Stopping extended phenytoin sodium capsules suddenly can cause serious problems. Extended phenytoin sodium capsules can cause serious side effects including: • Like other antiepileptic drugs, extended phenytoin sodium capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. • Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry or violent • acting on dangerous impulses • an extreme increase activity and talking (mania) • other unusual changes in behavior or mood • How can I watch for early symptoms of suicidal thoughts and actions? • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. • Keep all follow-up visits with your healthcare provider as scheduled. • Call your healthcare provider between visits as needed, especially if you are worried about symptoms. • Do not stop taking extended phenytoin sodium capsules without first 阅读完整的文件
PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE CARDINAL HEALTH ---------- DESCRIPTION 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: 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 1½ to 3 hours. Extended phenytoin sodium capsules USP, 100 mg meet _USP Dissolution Test 2._ 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 excessive stimulation or environmental changes capable of reducing membrane sodium gradient. This includes the reduction of post tetanic potentiation at synapses. Loss of post tetanic potentiation prevents cortical seizure foci from 阅读完整的文件