Sabril

Common name: Vigabatrin tablets

Trade name: Sabril

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

Indications:

Adjuvant treatment of anti-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 include 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, agitation, 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, and 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 become excited and anxious.

Contraindications:

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

Notes:

Anemia: associated with reduced hemoglobin and hematocrit; cases of significantly reduced hemoglobin (<8 g/dL) or reduced 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).

Edema: Peripheral edema and oedema have been reported to be associated with hypertension, heart failure, weight gain, and renal or hepatic insufficiency.

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

Peripheral neuropathy: Peripheral neuropathy occurs in adults and is characterized by numbness or tingling in the toes or feet, diminished vibration or position sensation in the distal lower extremities, or a progressive 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 loss: Vigabatrin can cause permanent vision loss in infants, children, and adults.

Weight gain: The average weight gain of adults is 3.5 kg, and the average weight gain of 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 dosage for 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.

Storage:

Put amine in a dry place at 20-25°C and keep it sealed and shielded from light. Keep medicines out of reach of children.

Mechanism of action:

This drug is a synthetic derivative of γ-aminobutyric acid (GABA). It increases the concentration of the inhibitory meridian medium 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. Its potential benefits for 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!