Country: United States
Language: English
Source: NLM (National Library of Medicine)
PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)
Wockhardt USA LLC.
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 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 sections). Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.
Extended phenytoin sodium capsules, USP 100 mg are available in orange/orange size '3' hard gelatin capsules imprinted on body 'W720' in black ink containing white to off white granular powder: 100's (NDC 64679-720-01) 1,000's (NDC 64679-720-02) Store at 20°-25°C (68°-77°F) (See USP controlled room temperature). Preserve in tight, light-resistant containers. Protect from moisture. Rx only Moban® is a registered trademark of Endo Pharmaceuticals, Inc. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Rev.030412
Abbreviated New Drug Application
EXTENDED PHENYTOIN SODIUM- EXTENDED PHENYTOIN SODIUM CAPSULE Wockhardt USA LLC. ---------- MEDICATION GUIDE Extended Phenytoin Sodium Capsules, USP 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, USP? 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 health-care 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. • Read the complete document
EXTENDED PHENYTOIN SODIUM- EXTENDED PHENYTOIN SODIUM CAPSULE WOCKHARDT USA LLC. ---------- 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 magnesium oxide light USP, hypromellose USP, colloidal silicon dioxide NF, talc USP, magnesium stearate NF. The capsule shell contains gelatin, titanium dioxide, D&C yellow # 10, FD&C blue # 1, FD&C red # 40 and black edible ink. 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 complies with USP Test 1 dissolution requirements. 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 Read the complete document