INDICATIONS AND USAGE

Refractory Complex Partial Seizures (CPS)

SABRIL is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. SABRIL is not indicated as a first line agent for complex partial seizures.

Infantile Spasms (IS)

SABRIL is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

DOSAGE

Refractory Complex Partial Seizures

Adults (Patients 17 Years of Age and Older)

Treatment should be initiated at 1000 mg/day (500 mg twice daily). Total daily dose may be increased in 500 mg increments at weekly intervals depending on response. The recommended dose of SABRIL in adults is 3000 mg/day (1500 mg twice daily).  A 6000 mg/day dose has not been shown to confer additional benefit compared to the 3000 mg/day dose and is associated with an increased incidence of adverse events.

Pediatric (Patients 2 to 16 Years of Age)

The recommended dosage is based on body weight and administered as two divided doses. The dosage may be increased in weekly intervals to the total daily maintenance dosage, depending on response.

Infantile Spasms

The initial daily dosing is 50 mg/kg/day given in two divided doses (25 mg/kg twice daily); subsequent dosing can be titrated by 25 mg/kg/day to 50 mg/kg/day increments every 3 days, up to a maximum of 150 mg/kg/day given in 2 divided doses (75 mg/kg twice daily).

ADVERSE REACTIONS

Permanent Vision Loss

Magnetic Resonance Imaging (MRI) Abnormalities in Infants

Neurotoxicity

Suicidal Behavior and Ideation

Withdrawal of Antiepileptic Drugs (AEDs)

Anemia

Somnolence and Fatigue

Peripheral Neuropathy

Weight Gain

Edema

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/a5d389d2-d0e1-4395-a2a2-b552808e7f98/spl-doc?hl=Sabril

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