Topiramate 25 mg Tablets (Topiramate)

Adult dosage

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 the elderly, in the absence of renal disease. This medicine may be taken with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic drugs must be stopped 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 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 treatment with 25㎎ in the evening during the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at 1-2-week intervals, divided into 2 doses per day. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and titration rate should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated doses of up to 1,000㎎ per day as 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, the dose may be increased to the maximum recommended dose of 800mg per day. Begin treatment with 25-50mg in the evening during the first week; a lower starting dose may also be used. Thereafter, increase the dose by 25-50mg at 1-2-week intervals, divided into 2 doses per day. If the patient has difficulty tolerating dose increases, smaller 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 these increases, extend the interval between dose increases. The recommended dose is 100mg per day, divided into 2 doses. Some patients may respond to a dose of 50mg per day. The dose may be increased to 200mg per day, with the dose and rate of titration 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 starting and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Because this medicine is removed from plasma by hemodialysis, the dose of this medicine should be increased by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's residual clearance, and administer the dose in divided portions at the beginning 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.

Children's dosage

Children (6-16 years): Start treatment with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1-2-week intervals, administered in 2 doses per day. If the patient has difficulty tolerating the increase, use smaller increments or extend the intervals between increases. The dose and degree of titration should be determined according to clinical response. The recommended dose for pediatric monotherapy is 3-6mg/kg per day. In children diagnosed with partial seizures, doses of up to 500㎎ per day have been used. Children (2-16 years): The recommended dose is approximately 5-9mg/kg per day, administered in 2 divided doses. During the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening. Thereafter, increase the total daily dose by 1-3mg/kg at 1-2-week intervals until an appropriate clinical effect is achieved, divided into 2 doses per day. 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 drug is an anticonvulsant used for epilepsy and migraine prevention, and it may increase the risk of suicidal thoughts or actions. Therefore, patients and guardians should immediately inform healthcare providers if symptoms such as depression, mood changes, or suicidal impulses appear. Furthermore, this drug can cause severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if skin rashes or abnormal symptoms occur, the medication should be stopped immediately and discussions with a doctor should occur. During pregnancy, it may cause harm to the fetus, so women of childbearing age should confirm their pregnancy status before taking this medication and should use effective contraceptive methods during treatment. Careful judgment is necessary when considering the use of this drug during pregnancy, as it may increase risks of fetal growth restriction or congenital malformations. This drug requires monitoring of blood concentration in patients with impaired renal function, and dosage adjustments are needed during hemodialysis. Since there is a risk of kidney stones, adequate fluid intake is important. While taking this drug, central nervous system side effects such as drowsiness, dizziness, and visual disturbances may occur, so caution is advised when driving or operating machinery. This drug may interact with other antiepileptic drugs or various medications; therefore, if there are other medications being taken, it is essential to inform a doctor or pharmacist. Discontinuing this drug abruptly may worsen seizures; thus, when stopping the medication, it must be reduced gradually according to the healthcare provider's instructions. Moreover, various side effects such as weight loss, anorexia, fatigue, depression, and memory impairment may occur while taking this drug, so it is crucial to consult healthcare providers if any unusual symptoms arise. Finally, this drug may increase body temperature due to decreased sweating, thus special care should be taken to manage body temperature, especially in children or when exposed to hot environments.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. Additionally, it is safest to store it at room temperature between 1°C to 30°C, avoiding excessively hot or cold places.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle