Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)
Proficient Rx LP
PHENYTOIN SODIUM
PHENYTOIN SODIUM 100 mg
ORAL
PRESCRIPTION DRUG
Phenytoin is indicated for the control of 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 ADMINISTRATIONand CLINICAL PHARMACOLOGYsections). Phenytoin is contraindicated in those patients with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins. Coadministration of phenytoin sodium 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, 100 mg are supplied as follows: Transparent # 3 capsule filled with white to off-white powder, with the code '402' imprinted on the cap and body. Bottles of 30: NDC 63187-891-30 Bottles of 60: NDC 63187-891-60 Bottles of 90 NDC 63187-891-90 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE Proficient Rx LP ---------- MEDICATION GUIDE EXTENDED PHENYTOIN (FEN-i-toyn) SODIUM CAPSULES, USP 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: 1. 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 talking to a healthcare provider. • Přečtěte si celý dokument
PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE PROFICIENT RX LP ---------- 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 Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains lactitol monohydrate, sodium lauryl sulfate, talc and magnesium stearate. The capsule shell contains gelatin, and black printing ink, which contains black iron oxide, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1, D&C Yellow No. 10, shellac glaze and SDA 3A alcohol or N-butyl alcohol and propylene glycol. 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 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 detonating adjacent cortical areas. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonic-clonic (grand mal) seizures. PHARMACOKINETICS AND DRUG METABOLISM 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 to 7 half- Přečtěte si celý dokument