Sabril

Common name: vigabatrin tablets

Product name: Sabril

All names: Vigabatrin, Vigabatrin, Sabril, Vigabatrin, Sabrilex, Vigadrone

Indications:

Adjunctive treatment against epilepsy.

Vigabatrin can be used as an auxiliary treatment for partial seizures in refractory complex epilepsy.

Vigabatrin can also be used to treat infantile spasms and Lennox-Gastaut syndrome.

Vigabatrin is used in tardive dyskinesia.

Usage and dosage:

Adults:

The recommended dose is 3g per day, taken in divided doses. The dose should be increased according to the clinical effect at a rate of 0.5-1g per day to 4g per day (or 50mg/kg per day), which is effective for complex partial seizures of epilepsy (with or without generalized tonic-clonic seizures).

Children:

General usage: For children aged 3-9 years, the recommended dose is 1g per day, taken in 2 times; for older children, 2g per day, taken in 2 times.

West syndrome: The average oral dose is 100mg/kg daily (range 50-150mg/kg).

Adverse reactions:

Common ones are fatigue, drowsiness, headache, dizziness, confusion and depression.

Occasional aggressive behavior and psychosis (more common in patients with a history of mental illness and behavioral problems), memory loss, diplopia, weight gain, gastrointestinal disorders, edema and hair loss.

Nystagmus, nervousness, irritability, ataxia, paresthesia, and tremor may also occur.

Some patients develop irreversible visual field defects, retinal lesions such as peripheral retinal atrophy, and more rarely, optic neuritis and atrophy.

Mental agitation, aggressive behavior, and paranoia may occur in people with or without a history of mental illness.

Mania or psychosis is also rare.

Hemoglobin and transaminase values ​​may be reduced.

Children may experience excitement and anxiety.

Taboo:

It is prohibited for those who are allergic to Vigabatrin, pregnant women, and breast-feeding people.

Notes:

Anemia: associated with decreased hemoglobin and hematocrit; cases of significant decreases in hemoglobin (<8 g/dL) or hematocrit (<24%) have been reported.

Central Nervous System Depression: May cause central nervous system depression, which may impair physical or mental abilities; patients must be cautioned not to perform tasks that require mental alertness (such as operating machinery or driving).

Neurotoxicity: Intramyelin edema has been (rarely) reported in infants. Patients must be closely monitored for potential neurotoxicity (observed in animal models but not in adults).

Peripheral neuropathy: Peripheral neuropathy occurs in adult patients and is manifested by numbness or tingling in the toes or feet, diminished vibration or position sensation in the distal lower limbs, or a gradual loss of reflexes.

Suicidal ideation: Patients taking antiepileptic drugs are at increased risk for suicidal ideation/behavior. Monitor changes in the patient's behavior and notify the doctor immediately if suicidal thoughts or symptoms of depression occur.

Visual Reduction: Vigabatrin can cause permanent vision loss in infants, children, and adults.

Weight gain: The average weight gain for adults is 3.5 kg, and the average weight gain for pediatric patients is more than 7%.

Psychotic behavior: Psychotic/anxiety reactions may occur more frequently in patients with a history of psychosis/psychosis.

Renal impairment: Use with caution in patients with renal insufficiency; adjust the dose in children and adults with renal insufficiency (CrCl <80 ml/min).

Seizures: May cause increased seizure frequency in some patients; use with caution in patients with myoclonic epilepsy.

Fetal Toxicity: Neonatal defects reported after use during pregnancy include: heart defects, limb defects, male genital malformations, fetal anticonvulsant syndrome, and renal and ear malformations.

Store:

Aminohepatic acid should be stored in a dry place at 20-25°C, shielded from light and sealed. Keep medicines out of reach of children.

Mechanism of action:

This drug is a synthetic derivative of gamma-aminobutyric acid (GABA), which increases the concentration of the inhibitory neurotransmitter GABA in the brain by irreversibly inhibiting GABA aminotransferase. It can increase the level of GABA in the human brain as the activity of GABA aminotransferase continues to decrease rapidly, and there is an obvious dose-effect relationship.

Safety and efficacy:

On August 21, 2009, the US FDA approved Sabril as a monotherapy for pediatric patients aged 1 month to 2 years old, where the potential benefits of infantile spasms outweigh the potential risk of vision loss, and as an adjuvant (additional) treatment for adult patients with refractory complex partial epilepsy (CPS).

On January 16, 2019, the FDA approved the launch of a generic version of Sabril (vigabatrin). Vigabatrin is sold under the brand name Sabril in Canada, Mexico, and the United Kingdom. The Danish brand name is Sabrilex.

In the past two years, more and more children with TSC have effectively controlled epilepsy by using Vigabatrin. Western countries even use Vigabatrin for early prevention of EEG abnormalities in children with TSC who have not yet developed the disease!