Sabril (Vigabatrin) is an antiepileptic drug used to treat specific types of epileptic seizures, with its main active ingredient being vigabatrin.

How to Use Sabril (Vigabatrin)

Administration Route and Dosage Forms

Sabril is available in two oral dosage forms: 500 mg film-coated tablets and 500 mg powder for oral solution.

The tablets can be taken orally directly, while the powder dosage form needs to be reconstituted first.

Both dosage forms can be taken with or without food and are bioequivalent.

Administration Frequency

All patients should receive the medication in two divided doses per day, once in the morning and once in the evening, to maintain stable blood drug concentrations.

Method for Reconstituting the Solution

When using the powder for oral solution, empty the entire contents of one 500 mg sachet into a clean cup, and add 10 mL of cold or room-temperature water to each sachet for dissolution.

A 3 mL or 10 mL oral syringe provided by the pharmacy must be used for accurate measurement and administration; household teaspoons or tablespoons are not suitable measuring tools.

The concentration of the reconstituted solution should be 50 mg/mL. If the solution is not clear or colorless, it should be discarded.

Each dose should be reconstituted immediately before use, and any unused portion should be discarded after administration.

Dosage Adjustment of Sabril (Vigabatrin)

Refractory Complex Partial Seizures

For adult patients (17 years of age and older), the initial dose is 1000 mg/day (500 mg, twice daily), followed by a weekly increase of 500 mg/day until reaching the recommended dose of 3000 mg/day (1500 mg, twice daily).

The recommended dose for pediatric patients (2 to 16 years of age) is based on body weight and administered in two divided doses.

Pediatric patients with a body weight exceeding 60 kg should receive the recommended adult dose.

Pediatric patients weighing 10–15 kg: initial dose of 350 mg/day, maintenance dose of 1050 mg/day.

Pediatric patients weighing 15–20 kg: initial dose of 450 mg/day, maintenance dose of 1300 mg/day.

Pediatric patients weighing 20–25 kg: initial dose of 500 mg/day, maintenance dose of 1500 mg/day.

Pediatric patients weighing 25–60 kg: initial dose of 500 mg/day, maintenance dose of 2000 mg/day.

Infantile Spasms

The initial daily dose is 50 mg/kg/day (25 mg/kg, twice daily), followed by an increase of 25–50 mg/kg/day every 3 days, up to a maximum of 150 mg/kg/day (75 mg/kg, twice daily).

Precautions for Discontinuation

For all indications, if Sabril needs to be discontinued, the dose should be reduced gradually to avoid withdrawal seizures.

In controlled clinical studies of adult complex partial seizures, Sabril was discontinued by reducing the dose by 1000 mg/day each week until the medication was stopped.

Medication Use in Special Populations for Sabril (Vigabatrin)

Patients with Renal Impairment

Sabril is mainly excreted through the kidneys, so dose adjustment is required for patients with renal impairment.

The adjustment plan for adult patients and pediatric patients aged 2 years and older is as follows:

For mild renal impairment (creatinine clearance > 50 to 80 mL/minute): the dose should be reduced by 25%.

For moderate renal impairment (creatinine clearance > 30 to 50 mL/minute): the dose should be reduced by 50%.

For severe renal impairment (creatinine clearance > 10 to 30 mL/minute): the dose should be reduced by 75%.

Information on dose adjustment for infants with renal impairment is not yet available.