Topiramate Tablet 25 Milligrams (Topiramate)

Adult dose

It is preferable to start this drug at a low dose and increase it to the effective dose. There is no need to monitor blood levels to optimize treatment with this drug. The recommended dose of this drug applies to all adults and children, including older adults, who do not have renal disease. This drug may be administered 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, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually reduced and discontinued by approximately one-third 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 drug may need to be reduced. Adults (17 years and older): Begin treatment with 25㎎ in the evening during the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at intervals of 1–2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating this rate of dose escalation, extend the interval between increases. The dose and rate of increase should be determined according to clinical response. The recommended dose for adult monotherapy is 100–200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000㎎ daily. 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. Begin 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. If the patient has difficulty tolerating the increased dose, the dose increase may be smaller or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Begin treatment with 25mg of this drug in the evening during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating the increases, extend the interval between increases. 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, and 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), it is recommended that the initial and maintenance doses be reduced to approximately 1/2. - Patients undergoing hemodialysis: Because this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis device, and the patient's residual clearance, and administer the increased dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as the clearance of this drug may be reduced.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors, so report any changes in mood or depressive symptoms to healthcare providers immediately during treatment. Patients taking this drug may be at higher risk of sudden death than the general population, but this is common within the range observed in epilepsy patients. It can cause serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis; if you develop a rash or blisters, stop taking the drug immediately and consult a doctor. Do not use if allergic to any component of this medication or if you have specific hereditary lactose intolerance. Women who are pregnant or planning to become pregnant should perform a pregnancy test before taking this medication and use effective contraception, as taking this medication during pregnancy can harm the fetus and should be done with caution. Patients with reduced kidney function may have slower drug clearance, increasing the risk of side effects, so dosage adjustments may be necessary. This drug may increase the risk of kidney stones, so adequate fluid intake is crucial. Drowsiness, dizziness, and blurred vision may occur during treatment, so caution is advised when driving or operating machinery. This medication may interact with other drugs, so inform your doctor or pharmacist of any current medications you are taking. If you experience sudden vision deterioration or eye pain while taking this medication, inform healthcare providers immediately, as there may be issues related to increased intraocular pressure requiring prompt treatment. Abrupt discontinuation of this medication may worsen seizures, so it should be tapered off gradually under medical supervision. Weight loss, decreased appetite, fatigue, and depression may occur; discuss any persisting symptoms with your healthcare provider. Pregnant or breastfeeding women should consult a specialist before taking this medication, considering its potential effects on the fetus or newborn. Regular blood tests and other necessary examinations should be conducted during treatment, and any abnormal symptoms should be reported immediately.

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

This medication should be stored in a sealed container as it may be sensitive to air or moisture. It is also important to keep it in a cool, dry place below 25 degrees Celsius to maintain its efficacy.

Appearance

White round film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle, For export - 30 tablets/box [10 tablets/PTP × 3]