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Basic Drug Info
Drug Name:Dilantin Kapseals
Manufacturer:Parke-Davis
Other Info:Rx onlyLAB-0375-1.0September 2007



Clinical Trials:


Indications and Usage
Dilantin is 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).
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 judgment 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, 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 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.

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