Topiramate 100 mg Tablet (Topiramate)

Adult dose

It is preferable to start this medication at a low dose and increase it to the effective dose. There is no need to monitor serum concentrations to optimize the dose of this medication. The recommended dose of this medication applies to all adults and children, including older adults, without renal disease. This medication may be taken with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy Adults (17 years and older): Start with 25 mg in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50 mg every 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and rate of titration should be determined based on clinical response. The recommended dose for monotherapy in adults is 100～200 mg/day. The maximum recommended dose is 500 mg/day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000 mg/day. 2) Adjunctive therapy Adults (17 years and older): The minimum effective dose is 200 mg/day; the usual dose is 200-400 mg/day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800 mg/day. Start treatment with 25-50 mg in the evening for the first week; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50 mg every 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller dose increments may be used or the interval between dose increases may be extended. The dose should be determined based on clinical effect. 2. Prevention of migraine Adults: Start with 25 mg of this medication 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 these increases, extend the interval between dose increases. The recommended dose is 100 mg/day, administered in 2 divided doses. Some patients may respond to a dose of 50 mg/day. Doses of up to 200 mg/day may be administered; the dose and rate of titration should be determined based on 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 starting and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Because this medication is removed from plasma by hemodialysis, patients on hemodialysis should increase their dose of this medication by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis equipment, 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 Use this medication with caution in patients with hepatic impairment, as its clearance may be reduced.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors during use, so patients and caregivers should alert healthcare professionals immediately if such symptoms occur. Patients taking this medication may have a slightly increased risk of sudden death, so regular monitoring and management are necessary. This medication can cause severe skin reactions, so if any abnormal symptoms like rashes or blisters appear, take it off immediately and consult a doctor. Patients with allergies to the included ingredients should not take this medication, nor should patients with lactose intolerance. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication and need to be cautious as it may harm the fetus if taken during pregnancy. This medication requires dosage adjustments for patients with reduced kidney function, and patients undergoing dialysis should adjust the dosage according to dialysis conditions. It is important to maintain adequate hydration while taking this medication, and drinking plenty of water is recommended to reduce the risk of kidney stones. This medication affects the central nervous system and can cause symptoms like drowsiness, dizziness, and blurred vision, so it is safe to avoid driving or operating machinery during the initial dose. During use, various neuropsychiatric side effects such as weight loss, depression, memory impairment, and decreased concentration may occur, so if symptoms are severe, consult healthcare professionals. This medication may interact with other drugs, so inform your doctor or pharmacist of any other medications you are taking. In particular, caution is needed if taken with other antiepileptic drugs, certain diabetes medications, contraceptives, or lithium preparations, as the medication's effects or side effects may vary. Sudden discontinuation of this medication may worsen seizures, so follow the doctor's instructions to taper off slowly.

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

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is also important to keep it in a cool, dry place at or below 25 degrees Celsius. Proper storage helps maintain the medication's effectiveness and safety.

Appearance

Yellow round film-coated tablets

Package unit

Domestic use - 30 tablets/bottle, Domestic use - 100 tablets/bottle, Export use - 30 tablets/box [10 tablets/PTP × 3]