Topiramax Tablet 25mg (Topiramate)

Adult dosage

It is preferable to start this drug at a low dose and titrate up to the effective dose. There is no need to monitor blood concentrations to optimize administration of this drug. The recommended dose of this drug is the same for all adults and children, including elderly patients, in the absence of renal disease. This drug may be taken with or without food. The tablet should be swallowed whole and not crushed. Epilepsy 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 need to be discontinued immediately for safety reasons, they should be tapered and discontinued 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 drug may need to be reduced. Epilepsy monotherapy in adults (17 years and older): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at 1-2 week intervals, administered in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the intervals between dose increases. The dose and rate of titration 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. Epilepsy adjunctive therapy in 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 up to the maximum recommended dose of 800mg per day. Start treatment with 25-50mg in the evening for the first week; treatment may also be started at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2 week intervals, administered in 2 divided doses. If the patient has difficulty tolerating the increased dose, a smaller dose increase or longer intervals between increases may be used. The dose should be determined according to clinical effect. Migraine prevention in adults: Start treatment with 25mg of this drug in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, extend the intervals between dose increases. The recommended dose is 100mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. The dose may be increased up to 200mg per day, with the dose and rate of titration determined according to clinical response. In patients with moderate to 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 undergoing hemodialysis: Since this drug is removed from plasma by hemodialysis, the dose of this drug should be increased by approximately 1/2 on the day of dialysis. Increase the dose taking into consideration the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer the additional dose in divided doses at the start and end of hemodialysis. Administer with caution to patients with hepatic impairment, as clearance of this drug may be reduced.

Children's dosage

Epilepsy monotherapy in children (6-16 years): Start treatment with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1-2 week intervals, administered twice daily. If the patient has difficulty tolerating the dose increase, reduce the dose increment or extend the intervals between increases. The dose and degree of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Experience is available with doses of up to 500㎎ per day in children diagnosed with partial seizures. Epilepsy adjunctive therapy in children (2-16 years): The recommended dose is approximately 5-9mg/kg per day, administered in 2 divided doses. For 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, administered in 2 divided 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 administered and were generally well tolerated.

This medication, used for epilepsy and migraine prevention, may increase the risk of suicidal thoughts or behaviors. Therefore, if symptoms such as depression or mood changes, or suicidal impulses occur during treatment with this medication, inform your healthcare provider immediately. This medication may carry a risk of sudden death in patients with epilepsy, so caution is advised. Additionally, serious skin reactions may occur during treatment, and if symptoms such as rash, blistering, or skin peeling develop, discontinue use immediately and consult a doctor. This medication should not be administered to patients with an allergy to any of its ingredients or those with lactose intolerance. Women who are pregnant or may become pregnant must take a pregnancy test before taking this medication and use effective contraception during treatment, as it can cause serious harm to the fetus if taken during pregnancy. Patients with renal or hepatic impairment may have delayed excretion of this medication, requiring dosage adjustments and careful monitoring. This medication may worsen seizures upon discontinuation of epilepsy treatment, so dosage must be gradually decreased according to the physician's instructions. Drowsiness, dizziness, and blurred vision may occur during treatment, so caution should be exercised while driving or operating machinery. Furthermore, this medication may increase the risk of kidney stone formation, so maintaining adequate hydration is very important. This medication may interact with other drugs, so if you are taking other medications, be sure to inform your healthcare provider. Pregnant and nursing women should consult a specialist before taking this medication due to risks to the fetus or newborn.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is important to store it in a cool and dry place below 25 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle