Topiramate Tablet 25mg (Topiramate)

Adult dose

It is advisable 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 dose of this medicine. The recommended dose of this medicine applies to all adults and children, including elderly patients, provided they do not have renal disease. It may be taken regardless of meals. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs to use topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, taper and discontinue the other antiepileptic drugs gradually, 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 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 intervals of 1-2 weeks and administer in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, the intervals between dose increases should be lengthened. The dose and rate of titration should be determined according to clinical response. The recommended dose for monotherapy in adults is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated doses of up to 1,000㎎ daily when taking topiramate as monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg daily, and the usual dose is 200-400mg daily in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg daily. Start treatment with 25-50mg in the evening during the first week; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks and administer in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, smaller dose increments may be used or the intervals 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 during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, the intervals between dose increases should be lengthened. The recommended dose is 100mg daily, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. The dose may be increased to 200mg daily; the dose and rate of titration should be determined according to clinical response. 3. Patients with renal impairment - In 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. - Hemodialysis patients: Because this medicine is removed from plasma by hemodialysis, the dose on dialysis days should be increased by approximately 1/2. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis system, and the patient's residual renal clearance, and administer the dose in divided portions at the start and end of hemodialysis. 4. Patients with hepatic impairment Use this medicine with caution in patients with hepatic impairment, as its clearance may be reduced.

Child dose

Pediatric patients (6–16 years) monotherapy: During the first week, begin treatment with 0.5-1㎎/㎏ in the evening. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks, dividing the dose into 2 daily doses. If the patient has difficulty tolerating dose increases, reduce the increments or extend the intervals between increases. The dose and extent of dose increase should be determined according to clinical response. The recommended dose for pediatric monotherapy is 3-6mg/kg per day. Doses of up to 500㎎ per day have been used in pediatric patients diagnosed with partial seizures. Pediatric patients (2–16 years) adjunctive therapy: The recommended daily dose is approximately 5-9mg/kg, divided into 2 doses. During the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening. Thereafter, increase the dose by 1-3mg/kg per day at intervals of 1-2 weeks, divided into 2 daily doses, until an appropriate clinical effect is achieved. Dose titration should be determined according to clinical effect. Doses of 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; therefore, if mood changes or symptoms of depression occur during treatment, healthcare professionals should be notified immediately. Severe skin reactions such as sudden skin rashes, blisters, or mucous membrane damage may occur while taking this medication; if these symptoms appear, discontinue use immediately and visit a hospital. Taking this medication during pregnancy may harm the fetus, so women who are pregnant or planning to become pregnant should consult their doctor and use effective contraception. Patients with reduced kidney function may have increased serum levels of this medication, requiring dose adjustments and regular monitoring. This medication can affect the central nervous system, causing symptoms such as drowsiness, dizziness, or blurred vision; thus, caution should be exercised while driving or operating machinery during the initial phase of treatment. Adequate hydration is important; a lack of hydration may increase the risk of kidney stones or related kidney problems, so water should be consumed frequently. Discontinuing this medication abruptly may worsen seizures, so if treatment needs to be stopped, it should be tapered off according to a doctor's instructions. This medication may interact with other drugs, so it is essential to inform healthcare professionals of any other medications being taken. Rarely, side effects such as weight loss, loss of appetite, depression, and memory impairment may occur; if these symptoms persist, consult healthcare professionals.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to store it in a cool, dry place below 25 degrees Celsius. Doing so will help maintain the medication's efficacy for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle