PEGANONE Tablet Ref.[10224] Active ingredients: Ethotoin

Source: FDA, National Drug Code (US)  Revision Year: 2017 

3. Indications and Usage

PEGANONE (ethotoin tablets, USP) is indicated for the control of tonic-clonic (grand mal) and complex partial (psychomotor) seizures.

10. Dosage and Administration

PEGANONE (ethotoin tablets, USP) is administered orally in 4 to 6 divided doses daily. The drug should be taken after food, and doses should be spaced as evenly as practicable. Initial dosage should be conservative. For adults, the initial daily dose should be 1 g or less, with subsequent gradual dosage increases over a period of several days. The optimum dosage must be determined on the basis of individual response. The usual adult maintenance dose is 2 to 3 g daily. Less than 2 g daily has been found ineffective in most adults.

Pediatric dosage depends upon the age and weight of the patient. The initial dose should not exceed 750 mg daily. The usual maintenance dose in children ranges from 500 mg to 1 g daily, although occasionally 2 or (rarely) 3 g daily may be necessary.

If a patient is receiving another antiepileptic drug, it should not be discontinued when PEGANONE therapy is begun. The dosage of the other drug should be reduced gradually as that of PEGANONE is increased. PEGANONE may eventually replace the other drug or the optimal dosage of both antiepileptics may be established.

In tonic-clonic (grand mal) seizures, use of the drug with phenobarbital may be beneficial.

9. Overdosage

Symptoms of acute overdosage include drowsiness, visual disturbance, nausea and ataxia. Coma is possible at very high dosage.

Treatment should be begun by inducing emesis; gastric lavage may be considered as an alternative. General supportive measures will be necessary. A careful evaluation of blood-forming organs should be made following recovery.

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