Detailed analysis of the instructions for use of Vigabatrin (vigabatrin)

Drug name

Generic name: vigabatrin

English name:Vigabatrin

Trade name: Vigabatrin (Sabril)

Ingredients

The active ingredient of this product is vigabatrin. Excipients include microcrystalline cellulose, hydroxypropyl methylcellulose, lactose, magnesium stearate, etc.

Indications

Vigabatrin is mainly suitable for two types of patients:

First-line treatment for infantile spasms (West syndrome), usually in infants younger than two years old.

It is used as an auxiliary treatment drug for adult and pediatric epilepsy patients with complex partial seizures who are refractory to other drug treatments.

Usage and dosage

When using Vigabatrin, the dose needs to be individually adjusted based on the patient's age, weight and severity of the disease.

Adult patients with epilepsy: The recommended starting dose is 500mg to 1g, taken in two divided doses, and the dose can be increased weekly based on clinical response, with the maximum daily dose not exceeding 3g.

Infantile spasms: The recommended starting dose is 50mg/kg per day, taken in two doses, which can be adjusted according to the condition. The maximum dose generally does not exceed 150mg/kg/day.

All doses should be taken as a whole tablet, with food or on an empty stomach, with water. The granular dosage form can be dissolved in a small amount of water and taken orally.

Contraindications

Contraindicated in patients with known hypersensitivity to vigabatrin or other components of this product.

It should be used with caution or disabled in patients with severe visual field defects.

Things to note

Risk of visual field defect: Vigabatrin can cause permanent visual field reduction or even blindness. A baseline visual inspection should be performed before taking the drug, and visual field changes need to be monitored regularly during the medication.

Psychiatric symptoms: Some patients may develop mental abnormalities such as depression, anxiety, and aggressive behavior, which require close observation and treatment adjustments if necessary.

Central nervous system depression: This product may cause drowsiness and dizziness. You should avoid driving or operating dangerous machinery while taking the drug.

Gradually discontinue the drug: The drug should be gradually reduced and discontinued under the guidance of a doctor to avoid aggravation of epileptic seizures caused by sudden drug withdrawal.

Renal Function Abnormalities: Dosage adjustments may be required in patients with reduced renal function, as vigabatrin is primarily excreted by the kidneys.

adverse reactions

Common adverse reactions include:

Visual impairment: such as decreased peripheral vision and constricted visual field.

Central nervous system reactions: such as fatigue, headache, drowsiness, and dizziness.

Psychiatric symptoms: such as depression, hallucinations, agitation, and irritability.

Digestive system reactions: such as nausea, vomiting, and weight gain.

Serious but rare adverse reactions include severe vision loss, severe depression, or suicidal ideation, which should require immediate medical attention.

drug interactions

Enhanced sedation may occur when vigabatrin is combined with other CNS depressants such as benzodiazepines.

When this product is used simultaneously with other anti-epileptic drugs (such as phenobarbital, phenytoin), there will generally be no clinically significant pharmacokinetic interactions, but it is still recommended to closely observe the efficacy and adverse reactions during combined treatment.

Pharmacokinetics

Vigabatrin is well absorbed after oral administration, and peak plasma concentration is generally reached within 2 hours after taking the drug. High bioavailability, about 60% to 80%. This product is not metabolized by the liver and is mainly excreted unchanged through the kidneys. The half-life is about 5 to 8 hours. However, the duration of the drug effect is not completely related to the plasma concentration because vigabatrin acts through irreversible inhibition of GABA transaminase.

storage

Should be stored in a cool and dry place (it is recommended that the temperature does not exceed 25°C) and avoid direct sunlight. Keep out of reach of children.

Packaging specifications

The common specifications of Vigabatrin are500mg tablet packaging, and there are also soluble granules. The quantity per box varies according to different markets and specifications.

Approval number and marketing authorization holder

The approval number differs according to different countries and regions. The marketing authorization holder is usually Sanofi SA or its subsidiaries.

Other things to note

During medication, it is recommended that patients and family members understand the importance of vision monitoring and ensure regular examinations.

When used in infants and young children, weight gain, motor development, and changes in seizure frequency should be closely monitored.

If patients experience abnormal behavioral changes during treatment, they should notify their doctor immediately and evaluate the risks and benefits of continuing to take the medication.

Reference materials:https://www.sabril.net/