Sabril Tablet 500 Milligrams (Vigabatrin)

Adult dose

1. Adults: Administer orally once or twice daily before or after meals. As the initial treatment dose, add 1g to the currently administered medication. If necessary, the dose may be increased by 0.5g at intervals of 1 week or longer according to clinical response and tolerability. The highest response rate is observed at a daily dose of 2g‐3g. The maximum recommended daily dose is 3g. 2. Patients with renal impairment and elderly patients: Because this medicine is excreted through the kidneys, use caution when administering it to elderly patients and especially to patients with creatinine clearance below 60mL/min. Initiate treatment at a lower dose in these patients and monitor closely for sedation or confusion.

Child dose

3. Children: The recommended initial treatment dose is 40mg per kg of body weight daily, and the recommended maintenance dose according to body weight is as follows. 10‐15kg: 0.5‐1g/day 15‐30kg: 1‐1.5g/day 30‐50kg: 1.5‐3g/day >50kg: 2‐3g/day The maximum recommended daily dose for each body weight range should not exceed the amounts in the table above. 4. Infantile spasms (West syndrome): The recommended initial treatment dose is 50mg per kg of body weight daily. If necessary, the dose may be increased at 1-week intervals up to a maximum of 150mg per kg of body weight daily. A response generally occurs within 2 weeks.

This medication may cause visual disturbances, so regular visual examinations should be performed during treatment. Men are at a higher risk of visual disturbances compared to women, thus caution is necessary. Visual disturbance may not recover even after discontinuation of the drug and may appear months to years after treatment. It should not be taken with other drugs that have retinal toxicity, and patients with visual disturbances should use this drug cautiously. It is important to consult with an ophthalmologist and undergo visual testing before starting treatment and every six months during treatment. Infants receiving this drug should be closely monitored for neurological side effects and mental health status should also be checked periodically. This medication may increase the risk of depression, suicidal thoughts, and behavioral changes, so patients and caregivers should be aware of these symptoms and report them to healthcare professionals immediately. Elderly patients or those with impaired kidney function, as well as those with a history of psychiatric illness or depression, should use this drug with extra caution. Drowsiness, fatigue, decreased concentration, and other symptoms may occur during medication, so caution is advised when driving or operating machinery. When discontinuing the drug, it should not be stopped suddenly, but gradually reduced over 2-4 weeks to lower the risk of seizures. Women who are pregnant or planning to become pregnant should consult a specialist about the use of this drug, and breastfeeding women should consider whether to discontinue breastfeeding based on the drug's effects.

• Visual impairment
• tunnel vision
• retinal disorders
• blurred vision
• optic nerve atrophy
• optic neuritis
• edema within the myelin sheath
• sedation
• drowsiness
• fatigue

This drug should be stored in a tightly closed container to prevent air or moisture from entering, and it is best to store it at room temperature, not too hot or too cold. Storing it this way will help maintain the drug's effectiveness and prevent degradation.

Appearance

White to off-white oval-shaped film-coated tablets with a division line on one side

Package unit

100 tablets (10 tablets/PTP*10)