Detailed Chinese instructions for Vigabatrin (Okeda)

1. Overview of Drugs

Vigabatrin (Vigabatrin) is a new anti-epileptic drug that is a gamma-aminobutyric acid (GABA) metabolism inhibitor. Its main mechanism of action is to irreversibly inhibit GABA aminotransferase (GABA-T) in the brain and reduce < span>GABA is degraded, thereby increasing the level of the inhibitory neurotransmitter GABA in the brain, enhancing neuron inhibitory signal conduction and reducing abnormal neural discharges. Due to its unique mechanism of action, Vigabatrin has shown significant efficacy in some refractory epilepsy and infantile spasms (West syndrome).

Vigabatrin is available as an oral tablet or oral solution, usually as a 500 mg tablet or liquid dose based on body weight. The drug is absorbed quickly in the body, and the blood concentration reaches its peak in 2-3 hours after oral administration, and can be excreted through the kidneys. When using, the dosage needs to be adjusted according to the patient's age, weight and disease type under the guidance of a doctor.

2. Indications

1.Infantile spasms (West syndrome)

Vibatrin is one of the first-line drugs for the treatment of infantile spasms and can be used to control spasms in children under 2 years old. Clinical studies show early use improves neurodevelopmental outcomes.

2.Refractory partial epilepsy

For adults or children with partial epilepsy who are ineffective with other anti-epileptic drugs, Vigabatrin can be used as an auxiliary drug, alone or in combination with other anti-epileptic drugs, to reduce the frequency and severity of seizures.

3.Combined treatment

Vigabatrin can be used in combination with other anti-epileptic drugs, especially in patients with refractory epilepsy, to improve the efficacy. During use, the dosage and dosage regimen need to be adjusted according to the condition and tolerance.

3. Usage and dosage

1.Dosage for infants and young children

The recommended starting dose is 50 mg/kg taken orally in two divided doses per day.

The dose can be gradually increased based on efficacy and tolerability, but the total daily dose usually does not exceed150 mg/kg.

Clinical response and plasma concentrations need to be monitored regularly to avoid overdose.

2.Dosage for children and adults

The usual starting dose is 25 mg/kg daily given in two divided doses.

Based on clinical efficacy and tolerability, it can be gradually increased to 100 mg/kg per day.

When taken orally, it can be taken with food to reduce gastrointestinal discomfort. Swallow the tablet whole or dissolve it in water.

3.Principles of dose adjustment

Patients with renal insufficiency need to reduce the dose and monitor plasma concentrations.

If serious adverse reactions occur, such as visual impairment or mental symptoms, the dose should be suspended or reduced.

4. Main side effects

Adverse reactions of Vigabatrin are relatively common and mainly include:

1.Central nervous system response

Drowsiness, dizziness, abnormal behavior, irritability, or decreased concentration.

Some children may experience mood swings and cognitive decline.

2.Visual damage

Long-term use may cause peripheral vision loss (shrinkage of peripheral vision), which is an irreversible side effect.

It is recommended to conduct visual field and retinal function tests before and regularly during medication.

3.Gastrointestinal reactions

Nausea, vomiting, diarrhea, or loss of appetite, usually mild to moderate, can be relieved by eating small amounts in divided doses.

4.Other reactions

Rare side effects include hematological abnormalities, weight changes, and mild increases in liver function parameters.

If serious side effects occur, you should seek medical advice promptly and adjust the dosage or discontinue the drug under the guidance of a doctor.

5. Medication precautions

1.Vision monitoring

Because Vigabatrin may cause irreversible visual field damage, patients need to undergo a baseline vision examination before taking the drug and have regular follow-up visits.

For long-term use, the visual field should be rechecked at least every 6 months. Children and patients who are unable to cooperate with vision examinations need to consider other objective examination methods.

2.Combined medication

It can be used in combination with other anti-epileptic drugs, but attention must be paid to drug interactions to avoid overdose or abnormal blood drug concentrations.

3.Kidney function monitoring

Vigabatrin is mainly excreted through the kidneys. Patients with renal insufficiency need to reduce the dose and regularly monitor blood concentration and renal function indicators.

4.Pregnancy and Breastfeeding

Use during pregnancy requires weighing the pros and cons and should be avoided in principle.

Use should be avoided during breastfeeding, or breastfeeding should be suspended to prevent the drug from affecting the baby through milk.

5.Life and daily management

Avoid driving and high-risk operations, especially if you are drowsy or dizzy.

Maintain a regular schedule, pay attention to nutritional intake and hydration, and improve tolerance.

6. Patient management and follow-up recommendations

Regular review: blood drug concentration, renal function and vision examination.

Record attacks: Record the number and type of attacks daily so that doctors can adjust the dosage.

Side effect management: promptly report symptoms of discomfort, such as drowsiness, abnormal behavior or vision loss.

Combination therapy evaluation: Evaluate whether to use it in combination with other anti-epileptic drugs based on efficacy and tolerability.

Vigabatrin (Vigabatrin), as a GABA-T inhibitor, has significant efficacy in patients with infantile spasms and refractory partial epilepsy. Rational use of medication, strict compliance with medical advice, regular monitoring of blood drug concentration and vision, and attention to kidney function and life management are the keys to ensuring efficacy and safety. In long-term management, patients and their families should closely cooperate with doctors and adjust treatment plans in a timely manner to achieve the goals of optimal seizure control and quality of life.

Reference materials:https://www.drugs.com/