Seti Tablet (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring of blood concentrations is not necessary to optimize the administration of this medicine. The recommended dose of this medicine applies to all adults and children, including the elderly, in the absence of renal disease. May be administered with or without food. Swallow tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy Adults (17 years and older): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase by 25 or 50㎎ per day at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating this rate of dose escalation, lengthen the interval between increases. The dose and rate of increase are determined by clinical response. The recommended dose for monotherapy in adults is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000㎎ per day. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg per day, and the usual dose is 200-400mg per day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg per day. Start treatment with 25-50mg in the evening for the first week; treatment may also be started at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, the dose may be increased by a smaller amount or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start treatment with 25mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, lengthen the interval between increases. The recommended dose is 100mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. Doses of up to 200mg per day may be administered; the dose and rate of increase should be determined according to clinical response. 3. Patients with renal impairment - For patients with moderate or severe renal impairment (CLcr < 70 mL/min/1.73 m2), it is recommended that the initial and maintenance doses be reduced to approximately 1/2. - Hemodialysis patients: Since this medicine is removed from plasma by hemodialysis, the dose on the day of dialysis should be increased by approximately 1/2. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis device, and the patient's renal clearance, and administer the dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

Pediatric patients (6-16 years), monotherapy: Start treatment with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase by 0.5-1㎎/㎏ per day at 1-2 week intervals and administer twice daily. If the patient has difficulty tolerating the increase, reduce the size of the dose increments or extend the interval between increases. The dose and extent of dose escalation should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Experience is available with doses of up to 500㎎ per day in children diagnosed with partial-onset seizures. Pediatric patients (2-16 years), adjunctive therapy: The recommended dose is approximately 5-9mg/kg per day, administered in 2 divided doses. For the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening; thereafter, increase by 1-3mg/kg per day at 1-2 week intervals until an appropriate clinical effect is achieved, administering the dose in 2 divided doses daily. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication is an anticonvulsant used for the prevention of epilepsy and migraines. During treatment, there may be an increased risk of suicidal thoughts or behaviors, so any changes in mood or unusual behavior should be reported to healthcare professionals immediately. Sudden skin rashes or severe skin reactions may occur during the use of this medication; if these symptoms appear, discontinue use and visit a hospital promptly. This medication may harm the fetus during pregnancy, so women of childbearing potential should take a pregnancy test before use and employ effective contraception. Patients with poor kidney or liver function may require careful monitoring and dosage adjustments due to changing drug concentrations. This medication may increase the risk of kidney stones, so it is important to stay hydrated by drinking enough water. Drowsiness, dizziness, and blurred vision may occur during treatment, so caution is advised when driving or operating machinery. Additionally, abruptly stopping this medication may worsen seizures, so it should be tapered off gradually. Drug interactions may occur if taken with other medications, so it is essential to inform healthcare providers of any current medications being taken. In particular, concomitant use with Valproate may lead to hyperammonemia.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• perceptual disturbances
• myoclonus
• ataxia

This medication should be stored in a tightly sealed container to protect it from air and moisture, ideally at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication’s effectiveness and prevent degradation.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle