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

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.

PEGANONE (ethotoin tablets, USP) 250 mg grooved, white tablets bearing the letters OV on one side and the number 61 on the other and are supplied in bottles of 100 (NDC 67386-601-01).

Recommended storage: Store below 77°F (25°C).

Dispense in a tight light-resistant container, as defined in the USP, with a child-resistant cap.

Manufactured by: Abbott Laboratories, North Chicago, IL 60064 U.S.A. OVATION PHARMACEUTICALS. INC. Deerfield. IL 60015. U.S A. Revised: January, 2007. FDA Rev date: 2/2/2007

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