Sabril (vigabatrin) is an oral antiepileptic drug primarily indicated for the treatment of specific types of epileptic seizures. It demonstrates significant clinical efficacy, yet is associated with severe potential risks, particularly permanent vision loss. Therefore, this medication must be used under strict risk assessment and management.

What are the indications for Sabril (vigabatrin)?

Refractory Complex Partial Seizures (CPS)

Patient Population: Suitable for pediatric and adult patients aged 2 years and above.

Treatment Position: Served as an adjunctive therapy (used in combination with other antiepileptic drugs).

Usage Premise: Patients must have an inadequate response to multiple alternative treatment options. Its use should only be considered when the potential therapeutic benefits clearly outweigh the risk of vision loss.

Efficacy Evaluation: If no significant clinical benefit is observed within 3 months of initiating treatment, discontinuation of the drug should be considered.

Infantile Spasms (IS)

Patient Population: Suitable for infants and young children aged 1 month to 2 years.

Treatment Position: Served as monotherapy.

Usage Premise: The use must be decided after a comprehensive evaluation by a physician, confirming that the potential therapeutic benefits significantly outweigh the potential risk of vision loss.

Efficacy Evaluation: If spasms are not significantly improved within 2 to 4 weeks of initiating treatment, discontinuation of the drug should be considered.

Dosage Forms and Characteristics of Sabril (vigabatrin)

Tablets

Specification: Each tablet contains 500 mg of vigabatrin.

Characteristics: White, oval, film-coated tablets, biconvex, with a score line on one side and the marking "OV111" engraved on the other side.

Application: Mainly intended for use by adults and older children who can swallow tablets.

Powder for Oral Solution

Specification: Each sachet contains 500 mg of vigabatrin.

Characteristics: White to off-white granular powder, which needs to be dissolved in water before administration.

Application: Specially designed for infants and young children, patients with swallowing difficulties, or situations requiring precise dose adjustment.

Storage Methods for Sabril (vigabatrin)

Storage Conditions

Environmental Requirements: Store at room temperature between 20°C and 25°C (68°F and 77°F).

Precautions: Avoid storing the medication in humid places such as bathrooms or beside kitchen sinks, or in locations that may be exposed to high temperatures or direct sunlight, such as inside cars or on windowsills.

Medication Handling

Solution Preparation: The powder for oral solution must be dissolved immediately before administration using the specified amount of cold or room-temperature water. The prepared solution should be clear and colorless. If the solution is turbid or contains particles, it should be discarded.

Validity Period: The prepared solution should be administered immediately and must not be stored for future use. Any remaining solution should be discarded after each dose.

Safe Storage: All medications should be kept out of the reach and sight of children to prevent accidental ingestion.