Seti Tablet 25 Milligrams (Topiramate)

Adult dose

It is preferable to start this drug at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize treatment with this drug. The recommended dose of this drug applies to all adults and children, including elderly patients, in the absence of renal disease. This drug may be administered without regard to meals. Tablets should be swallowed whole and not crushed. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to use topiramate as monotherapy, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually reduced and discontinued by approximately 1/3 every 2 weeks (see “5. General precautions” under Precautions for use). When enzyme-inducing drugs are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentration occurs, the dose of this drug may need to be reduced. Adults (17 years or older): Start with 25 mg in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50 mg at 1- to 2-week intervals, divided into 2 doses per day. If the patient has difficulty tolerating this titration schedule, extend the titration interval. The dose and titration rate should be determined according to clinical response. The recommended dose for adult monotherapy is 100–200 mg per day. The maximum recommended dose is 500 mg per day. Some patients with recurrent epilepsy have tolerated doses of up to 1,000 mg per day of topiramate monotherapy. 2) Adjunctive therapy Adults (17 years or older) The minimum effective dose is 200 mg per day, and the usual dose is 200-400 mg per day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800 mg per day. Start treatment with 25-50 mg in the evening for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50 mg at 1- to 2-week intervals, administered in 2 divided doses per day. If the patient has difficulty tolerating the increased dose, the dose increment may be reduced or the titration interval extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25 mg of this drug in the evening for the first week. Thereafter, increase the dose by 25 mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, extend the titration interval. The recommended dose is 100 mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50 mg per day. Doses of up to 200 mg per day may be administered; the dose and titration rate 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 drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on the day of dialysis. Adjust the dose considering the duration of dialysis, the clearance of the dialysis apparatus, and the patient's renal clearance, and administer in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment because clearance of this drug may be reduced.

Child dose

1. Epilepsy 1) Monotherapy Children (6-16 years) Start with 0.5-1 mg/kg in the evening for the first week. Thereafter, increase the dose by 0.5-1 mg/kg per day at 1- to 2-week intervals and administer in 2 divided doses per day. If the patient has difficulty tolerating the increase, reduce the increment or extend the titration interval. The dose and titration amount should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6 mg/kg per day. Doses of up to 500 mg per day have been used in children diagnosed with partial seizures. 2) Adjunctive therapy Children (2-16 years) The recommended dose is approximately 5-9 mg/kg per day, administered in 2 divided doses. Administer 25 mg (or less, based on 1-3 mg/kg per day) in the evening for the first week; thereafter, increase the dose by 1-3 mg/kg per day at 1- to 2-week intervals until an appropriate clinical effect is achieved, in 2 divided doses per day. Dose titration should be determined according to clinical effect. Doses of up to 30 mg/kg per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behavior, so careful observation for mood changes or depressive symptoms is necessary during treatment. Additionally, there is a risk of sudden death in patients with epilepsy, so regular health assessments are required. This medication can cause serious skin reactions, so if a rash or blisters appear on the skin, discontinue use immediately and consult a doctor. Those allergic to the ingredients should not take this medication, and caution is necessary for patients with lactose intolerance. Pregnant women or those planning to become pregnant should consult a doctor before taking this medication, especially for migraine prevention purposes, it is not administered to women who may become pregnant. Patients with impaired kidney or liver function need to adjust the dosage according to the doctor's instructions, as drug concentration may change. It is important to maintain adequate hydration during treatment, and to drink plenty of water to reduce the risk of kidney stones. Symptoms such as drowsiness, dizziness, or blurred vision may occur during treatment, so caution is advised when driving or operating machinery. Abrupt discontinuation of this medication may increase the risk of seizures, so the dosage should be gradually reduced according to the doctor's instructions. Additionally, there may be interactions with other medications, so it is essential to inform the doctor of any other medications being taken. This medication may cause malformations or growth delays in a fetus, so it should be used with full awareness of the risks when taken during pregnancy. If symptoms of weight changes, mood changes, or memory decline appear during treatment, consultation with healthcare professionals is necessary.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• paresthesia
• hyperreflexia
• ataxia

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle