Topiramate Tablet 100mg

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, who do not have renal disease. This medicine may be taken with or without food. Swallow the tablet whole; do not crush it. 1. Epilepsy 1) Monotherapy When discontinuing other concomitant antiepileptic drugs in order to use topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, gradually reduce and discontinue the other antiepileptic drugs by approximately 1/3 every 2 weeks (see Precautions for Use, “5. General Precautions”). When an enzyme-inducing drug is discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentration occurs, the dose of this medicine may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening during the first week. Thereafter, increase by 25 or 50㎎ per day at 1-2 week intervals, divided into 2 daily doses. If the patient has difficulty tolerating this titration schedule, lengthen the titration interval. The dose and rate of increase should be determined according to 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 up to 1,000㎎ per day of topiramate monotherapy. 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, doses up to the maximum recommended dose of 800mg per day may be used. Start treatment with 25-50mg in the evening during the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at 1-2 week intervals, divided into 2 daily doses. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this medicine in the evening during the first week. Thereafter, increase by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, lengthen the titration interval. The recommended dose is 100mg per day, divided into 2 doses. Some patients may respond to a dose of 50mg per day. Doses of up to 200mg per day may be used; 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), reduction of the starting and maintenance doses to approximately 1/2 is recommended. - Hemodialysis patients: Because this medicine is removed from plasma by hemodialysis, increase the dose by approximately 1/2 on dialysis days. Adjust the dose taking into account dialysis duration, dialyzer clearance, and the patient's renal clearance, and divide the dose between the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors in patients taking it, so patients and caregivers should inform healthcare professionals immediately if such symptoms arise. Additionally, during treatment with this medication, serious rashes or blisters may develop on the skin; if such symptoms occur, it is essential to discontinue the medication and consult a physician. This medication may alter blood levels in patients with impaired kidney function; therefore, dosages should be adjusted according to kidney function. Women planning a pregnancy or who may become pregnant must take a pregnancy test before taking this medication and use effective contraception during treatment. Taking this medication during pregnancy may pose risks of congenital malformations or growth delays in the fetus, so it should be administered with caution based on medical judgment during pregnancy. This medication may affect the central nervous system causing symptoms such as drowsiness, dizziness, and blurred vision, so caution is advised when driving or operating machinery during the initial phase of dosing. It is crucial to ensure adequate hydration during treatment to reduce the risk of kidney stones, paying particular attention to hydration before and after physical activity or in hot weather. Abruptly discontinuing this medication may lead to seizures; therefore, it must be tapered off gradually under the direction of a physician when stopping treatment. Additionally, this medication may interact with other drugs, so any other medications being taken must be reported to the physician or pharmacist. Lastly, during treatment, unusual symptoms such as weight changes, mood changes, or appetite changes may occur; if these symptoms persist or worsen, consult healthcare professionals.

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

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is best stored at room temperature between 1 to 30 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle