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Basic Drug Info
Drug Name:Phenytoin Sodium
Manufacturer:HOSPIRA, INC.
Other Info:



Clinical Trials:


Indications and Usage
Parenteral phenytoin is indicated for the control of status epilepticus of the grand mal type, and prevention and treatment of seizures occurring during neurosurgery.
Status Epilepticus -- A prolonged seizure or seizures repeated frequently enough to prevent recovery between episodes occurring over a period of 20-30 minutes. The most common subtype is generalized tonic-clonic status epilepticus, a potentially fatal condition associated with neuronal injury and respiratory and metabolic dysfunction. Nonconvulsive forms include petit mal status and complex partial status, which may manifest as behavioral disturbances. Simple partial status epilepticus consists of persistent motor, sensory, or autonomic seizures that do not impair cognition (see also EPILEPSIA PARTIALIS CONTINUA). Subclinical status epilepticus generally refers to seizures occurring in an unresponsive or comatose individual in the absence of overt signs of seizure activity. (From N Engl J Med 1998 Apr 2;338(14):970-6; Neurologia 1997 Dec;12 Suppl 6:25-30)

Tonic - clonic seizures -- A generalized tonic-clinic seizure, characterized by loss of consciousness. This type of seizure may be preceded by an aura and is frequently followed by a period of confusion and lethargy (post-ictal state).

SPONDYLOMETAEPIPHYSEAL DYSPLASIA, SHORT LIMB-HAND TYPE --

Tonic-Clonic Epilepsy -- A generalized seizure disorder characterized by recurrent major motor seizures. The initial brief tonic phase is marked by trunk flexion followed by diffuse extension of the trunk and extremities. The clonic phase features rhythmic flexor contractions of the trunk and limbs, pupillary dilation, elevations of blood pressure and pulse, urinary incontinence, and tongue biting. This is followed by a profound state of depressed consciousness (post-ictal state) which gradually improves over minutes to hours. The disorder may be cryptogenic, familial, or symptomatic (caused by an identified disease process). (From Adams et al., Principles of Neurology, 6th ed, p329)

Contraindications
Phenytoin is contraindicated in patients with a history of hypersensitivity to hydantoin products.Because of its effect on ventricular automaticity, phenytoin is contraindicated in sinus bradycardia, sino-atrial block, second and third degree A-V block, and patients with Adams-Stokes syndrome.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Sinus bradycardia -- A heart rate of less than 60 beats per minute, with its origin in the sinus node. (NCI)

Adams-Stokes Syndrome -- A condition of fainting spells caused by heart block, often an atrioventricular block, that leads to BRADYCARDIA and drop in CARDIAC OUTPUT. When the cardiac output becomes too low, the patient faints (SYNCOPE). In some cases, the syncope attacks are transient and in others cases repetitive and persistent.

Warnings

Intravenous administration should not exceed 50 mg per minute in adults.In neonates, the drug should be administered at a rate not exceeding 1 mg/kg/min to 3 mg/kg/min.Severe cardiotoxic reactions and fatalities have been reported with atrial and ventricular conduction depression and ventricular fibrillation.

Severe complications are most commonly encountered in elderly or gravely ill patients.Phenytoin should be used with caution in patients with hypotension and severe myocardial insufficiency.Hypotension usually occurs when the drug is administered rapidly by the intravenous route.The intramuscular route is not recommended for the treatment of status epilepticus since blood levels of phenytoin in the therapeutic range cannot be readily achieved with doses and methods of administration ordinarily employed.There have been a number of reports suggesting a relationship between phenytoin and the development of lymphadenopathy (local or generalized) including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin’s disease. Although a cause and effect relationship has not been established, the occurrence of lymphadenopathy indicates the need to differentiate such a condition from other types of lymph node pathology.

Lymph node involvement may occur with or without symptoms and signs resembling serum sickness e.g., fever, rash, and liver involvement.In all cases of lymphadenopathy, follow-up observation for an extended period is indicated and every effort should be made to achieve seizure control using alternative antiepileptic drugs.Acute alcoholic intake may increase phenytoin serum levels while chronic alcoholic use may decrease serum levels.
Branded Drugs
The following US Branded drugs contain Phenytoin Sodium


DILANTIN -- PARKE DAVIS DIV WARNER LAMBERT CO

DIPHENYLAN SODIUM -- LANNETT CO INC

EXTENDED PHENYTOIN SODIUM -- AMNEAL PHARMACEUTICALS NY LLC

EXTENDED PHENYTOIN SODIUM -- BARR LABORATORIES INC

EXTENDED PHENYTOIN SODIUM -- MYLAN PHARMACEUTICALS INC

EXTENDED PHENYTOIN SODIUM -- PLIVA INC

EXTENDED PHENYTOIN SODIUM -- SUN PHARMACEUTICAL INDUSTRIES LTD

EXTENDED PHENYTOIN SODIUM -- TARO PHARMACEUTICAL INDUSTRIES LTD

EXTENDED PHENYTOIN SODIUM -- WOCKHARDT LTD

EXTENDED PHENYTOIN SODIUM -- WOCKHARDT USA INC

PHENYTEK -- MYLAN PHARMACEUTICALS INC

PHENYTEX -- WATSON LABORATORIES INC

PROMPT PHENYTOIN SODIUM -- IVAX PHARMACEUTICALS INC

PROMPT PHENYTOIN SODIUM -- WATSON LABORATORIES INC

DILANTIN -- PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO


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