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Basic Drug Info
Drug Name:Phenytoin Sodium
Manufacturer:Taro Pharmaceuticals U.S.A., Inc.
Other Info:

Mfd.

by: Taro Pharmaceutical Industries Ltd.Haifa Bay, Israel 26110Dist.

by: Taro Pharmaceuticals U.S.A., Inc.Hawthorne, NY 10532Issued: May, 200671074-0506-0



Clinical Trials:


Indications and Usage
Extended Phenytoin Sodium Capsules USP, 100 mg 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).
Widespread Disease --

Contraindications
Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Abrupt withdrawal of phenytoin in epileptic patients may precipitate status epilepticus.

When, in the judgement of the clinician, the need for dosage reduction, discontinuation, or substitution of alternative antiepileptic medication arises, this should be done gradually.

However, in the event of an allergic or hypersensitivity reaction, rapid substitution of alternative therapy may be necessary.

In this case, alternative therapy should be an antiepileptic drug not belonging to the hydantoin chemical class.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, eg, 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 alcohol use may decrease serum levels.In view of isolated reports associating phenytoin with exacerbation of porphyria, caution should be exercised in using this medication in patients suffering from this disease.
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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