Sabril is an antiepileptic drug that belongs to the gamma aminobutyric acid (GABA) aminotransferase inhibitor. It irreversibly inhibits GABA metabolizing enzymes, increases GABA concentration in the brain, enhances GABAergic neurotransmission, and exerts antiepileptic effects.

1、 Drug name:

1. Product Name: Sabril

2. Common name: Vigabatrin

2、 Indications:

1. Used to treat adult and pediatric patients aged 2 years and older with refractory complex partial seizures (CPS) who have poor response to multiple alternative treatment options and whose potential benefits outweigh the risk of vision loss.

2. Used to treat infantile spasms (IS) in infants aged 1 month to 2 years, as a monotherapy, when the potential benefits outweigh the risk of vision loss.

3、 Specifications

Tablets: 500mg.

4、 Main components:

Active ingredient: vigabatrin

5、 Usage and dosage:

1. Adult complex partial seizures: The initial dose is 1000mg/day (taken in two doses), with an increase of 500mg/day per week until the recommended dose of 3000mg/day (taken in two doses) is reached.

2. Pediatric complex partial seizures: The dosage is based on body weight and taken in two doses. The specific dosage is shown in the instruction manual table.

3. Infantile spasms: The initial dose is 50mg/kg/day (taken in two doses), and the maximum dose can reach 150mg/kg/day (taken in two doses).

6、 Dose adjustment:

Patients with renal insufficiency need to adjust the dosage: mild renal insufficiency (CLcr>50 to 80mL/min) should be reduced by 25%, moderate renal insufficiency (CLcr>30 to 50mL/min) should be reduced by 50%, and severe renal insufficiency (CLcr>10 to 30mL/min) should be reduced by 75%.

7、 Medication precautions:

1. Before and after meals: can be taken with food or on an empty stomach.

2. Missed dose: If missed, it should be taken as soon as possible, but if it is close to the next dose, skip the missed dose and do not double the dose.

3. Vomiting: If vomiting occurs after taking medication, do not repeat the administration and continue with the next dose at the normal time.

8、 Medication for special populations:

1. Pregnant women: Based on animal data, it may cause harm to the fetus, and the pros and cons need to be weighed.

2. Breastfeeding women: Medications can be excreted into breast milk, breastfeeding is not recommended.

3. Children: The safety and efficacy of treating infantile spasms in children aged 2 to 16 have been established, while the safety and efficacy of treating infantile spasms in children under 2 years old have not been established.

4. Elderly individuals: Renal function may decline, caution should be exercised in selecting dosage and monitoring renal function.

9、 Adverse reactions:

1. Permanent loss of vision: may cause permanent bilateral concentric field of view reduction, including tunnel field of view, and in severe cases may affect visual acuity.

2. Other common adverse reactions in adults include blurred vision, drowsiness, dizziness, abnormal coordination, tremors, and fatigue; Children, including weight gain.

3. Serious adverse reactions: MRI abnormal signal changes, neurotoxicity, suicidal behavior and ideation, anemia, peripheral neuropathy, edema, etc.

10、 Contraindications:

There are no specific contraindications.

11、 Drug interactions:

1. Phenytoin Sodium: May lower plasma levels of phenytoin Sodium, and dosage needs to be monitored and adjusted.

2. Other antiepileptic drugs: There is no significant pharmacokinetic interaction with phenobarbital or sodium valproate.

3. Oral contraceptives: may not affect the efficacy of hormonal oral contraceptives.

12、 Storage method:

Store at controlled room temperature of 20 ° C to 25 ° C (68 ° F to 77 ° F).

Sabrilinformation