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

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.

Tablets can be taken orally directly, while the powder dosage form requires reconstitution first.

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

Administration Frequency

All patients should receive the medication twice daily (once in the morning and once in the evening) to maintain stable blood concentrations.

Solution Reconstitution Method

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

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 appropriate measuring tools.

The concentration of the reconstituted solution should be 50 mg/mL. Discard the solution if it is not clear or colorless.

Each dose should be reconstituted immediately before use. Any unused portion should be discarded after administration.

Dosage Adjustments for Sabril (Vigabatrin)

Refractory Complex Partial Seizures

For adult patients (17 years and older): The initial dose is 1000 mg/day (500 mg twice daily), followed by weekly increments of 500 mg/day until the recommended maintenance dose of 3000 mg/day (1500 mg twice daily) is reached.

The recommended dose for pediatric patients (2 to 16 years old) is weight-based, administered in two divided doses.

Pediatric patients weighing more than 60 kg should receive the adult recommended dose.

Patients weighing 10–15 kg: Initial dose 350 mg/day; maintenance dose 1050 mg/day.

Patients weighing 15–20 kg: Initial dose 450 mg/day; maintenance dose 1300 mg/day.

Patients weighing 20–25 kg: Initial dose 500 mg/day; maintenance dose 1500 mg/day.

Patients weighing 25–60 kg: Initial dose 500 mg/day; maintenance dose 2000 mg/day.

Infantile Spasms

The initial daily dose is 50 mg/kg/day (25 mg/kg twice daily), which can be increased by 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 tapered gradually to avoid withdrawal seizures.

In controlled clinical studies of adult complex partial seizures, Sabril was tapered at a rate of 1000 mg/day per week until complete discontinuation.

Use in Special Populations

Patients with Renal Impairment

Sabril is primarily excreted via the kidneys, so dose adjustments are required for patients with renal impairment.

Dosage adjustment plan for adults and pediatric patients aged 2 years and older:

Mild renal impairment (creatinine clearance >50 to 80 mL/min): Reduce dose by 25%.

Moderate renal impairment (creatinine clearance >30 to 50 mL/min): Reduce dose by 50%.

Severe renal impairment (creatinine clearance >10 to 30 mL/min): Reduce dose by 75%.

Dosage adjustment information for infants with renal impairment is not available.

Pregnancy and Lactation

Based on animal data, Sabril may cause fetal harm.

Sabril is excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment.