Topiramate 25 mg Tablets

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize the dose of this medicine. The recommended dose of this medicine is the same for all adults and children, including elderly patients, in the absence of 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 administer topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic drugs must be stopped immediately for safety reasons, gradually reduce and discontinue them by approximately 1/3 at 2-week intervals (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. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and titration rate are 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 topiramate monotherapy at doses up to 1,000㎎ per day. 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 administered. 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 intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller dose increases may be made 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 increase, extend the interval between dose increases. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. Doses up to 200mg per day may be administered; the dose and titration rate 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 initial and maintenance doses be reduced to approximately 1/2. - Hemodialysis patients: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, dialyzer clearance, 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 Administer this medicine with caution to 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 intervals of 1-2 weeks and administer twice daily. If the patient has difficulty tolerating the increase, reduce the size of the dose increments or extend the intervals between increases. The dose and degree of titration are 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 daily dose is approximately 5-9mg/kg, 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 by 1-3mg/kg per day at intervals of 1-2 weeks until an appropriate clinical effect is achieved, administered in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg per day have been administered and were generally well tolerated.

This drug is used as an anticonvulsant for the prevention of epilepsy and migraines. During treatment, there may be an increased risk of suicidal thoughts or behaviors, so patients and caregivers should notify healthcare professionals immediately if any mood changes or unusual behaviors occur. Abrupt discontinuation of this medication may lead to seizures or an increase in seizure frequency, so it is important to gradually reduce the dosage. Furthermore, this medication may affect the central nervous system, causing symptoms such as drowsiness, dizziness, and blurred vision; therefore, it is advisable to avoid driving or operating machinery during the initial stages of treatment. This drug can cause serious skin reactions, including Stevens-Johnson syndrome or toxic epidermal necrolysis; therefore, if symptoms such as skin rash, blisters, or mucosal damage occur, it must be discontinued immediately. Patients with decreased kidney function may experience delayed excretion of this medication, necessitating dosage adjustments, and there is a risk of kidney stones, making adequate hydration important. Additionally, patients with compromised liver function should also use this medication with caution. Use during pregnancy may pose risks such as birth defects or growth restrictions in the fetus; therefore, women of childbearing age should take a pregnancy test before use and employ effective birth control methods, especially during pregnancy, where the administration of this medication should only be determined after careful consideration. This drug can interact with other anticonvulsants; thus, it is essential to inform healthcare professionals of any other medications being taken, particularly as its concentration may change when used in combination with phenytoin or carbamazepine, possibly requiring dosage adjustments. While taking this medication, various side effects such as weight loss, fatigue, dizziness, memory impairment, mood changes, loss of appetite, nausea, diarrhea, etc., may occur. If any symptoms are severe or persistent, consultation with healthcare professionals is advised. Finally, it is important to maintain adequate hydration and have regular medical check-ups during the course of treatment to closely monitor for any unusual symptoms or side effects arising from this medication.

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

This medication should be stored in a sealed container, as it may be sensitive to air or humidity. Additionally, it should be kept in a cool, dry place below 25 degrees Celsius to maintain its effectiveness.

Appearance

Yellow round film-coated tablets

Package unit

300 tablets/bottle, 30 tablets/bottle