Topimate Tablet (Diet)

[Change in Approval (Unification Adjustment) Drug Review and Coordination Department-5385, 2014.10.06

It is recommended to start with a low dose of this drug and increase the dose to the effective dose.

It is not necessary to monitor blood levels to optimize dosing of this drug.
The recommended dosage of this drug applies to all adults and children, including the elderly, if they do not have kidney disease.
It can be administered regardless of meals.
The tablets should be taken as is without crushing.

1. Epilepsy
1) Monotherapy: When discontinuing other concomitant antiepileptic drugs to administer topiramate as monotherapy, the possible impact on seizure control must be considered. Except in cases where other antiepileptic drugs must be discontinued immediately due to safety concerns, gradually reduce and discontinue other antiepileptic drugs by about 1/3 at two-week intervals (see “5. General precautions” for use).
When drugs that induce drug-metabolizing enzymes are discontinued, topiramate concentrations may increase. If an increase in topiramate concentration appears clinically, it is necessary to reduce the dose of this drug.

Adults (17 years and older):
Start taking 25 mg in the evening for the first week. Afterwards, the dose should be increased by 25 or 50 mg per day at intervals of 1-2 weeks and divided into two doses per day. If the patient finds it difficult to tolerate this increase, the interval between doses should be lengthened. Dosage and rate of increase are determined based on clinical response. The recommended dose as monotherapy for adults is 100 to 200 mg per day. The maximum recommended dose is 500 mg per day. Some patients with relapsed epilepsy tolerated up to 1,000 mg/day of topiramate monotherapy.

Children (6-16 years)
For the first week, start administration at 0.5-1mg/kg in the evening. Afterwards, increase the dose by 0.5-1 mg/kg per day at intervals of 1-2 weeks and administer twice a day. If the patient finds it difficult to tolerate the increase, reduce the dose increase or increase the interval between doses. The dose or degree of increase is determined based on clinical response.
The recommended dose as monotherapy for children is 3-6 mg/kg per day. In children diagnosed with partial seizures, doses of up to 500 mg per day have been administered.

2) Additional therapy
Adult (17 years and older)
The minimum effective dose is 200 mg per day, and usually 200-400 mg per day is administered in two divided doses. Depending on the patient, the maximum recommended dose of 800 mg per day can be administered. Treatment begins with 25-50 mg administered in the evening for the first week, although it is possible to start with lower doses. Afterwards, the dose is increased by 25-50mg at intervals of 1-2 weeks and administered twice a day. If the patient has difficulty tolerating the increased dose, a smaller dose may be increased or the interval between increased doses may be extended. Dosage should be determined based on clinical effect.

Children (2-16 years)
The recommended daily dose is approximately 5-9 mg/kg, divided into two doses per day. For the first week, administer 25 mg (or less, based on 1-3 mg/kg per day) in the evening, and thereafter, administer 1-3 mg/day at 1-2 week intervals until an appropriate clinical effect appears. Increase the dose by kg and administer twice a day. Dosage titration should be determined based on clinical effect. In some cases, up to 30 mg/kg per day was administered, and in this case, it was generally well tolerated.

2. Prevention of migraines
Adults: For the first week, start taking 25 mg of this drug in the evening. Afterwards, increase the dose by 25 mg/day at one-week intervals. If the patient finds it difficult to tolerate this dose increase, the interval between doses should be lengthened. The recommended daily dose is 100 mg, divided into two doses per day. In some patients, even a dose of 50 mg per day may be effective. Up to 200 mg per day can be administered, and the dose and rate of increase should be determined based on clinical response.

3. Patients with renal impairment
- For patients with moderate to severe (CLcr < 70 mL/min/1.73 m2) renal impairment, it is recommended to reduce the starting dose and maintenance dose to approximately 1/2.
- Hemodialysis patients: Since this drug is removed from the plasma through hemodialysis, hemodialysis patients should increase the dose of this drug by about 1/2 on the day of dialysis. The dosage should be increased considering the time required for dialysis, the clearance rate of the dialysis device, and the dropout rate of dialysis patients, and administered in divided doses at the start and end of hemodialysis.

4. Patients with liver failure
Patients with hepatic impairment should be administered with caution as clearance of this drug may be reduced.

4) Ingredients, content

5) Period of use

36 months from date of manufacture

6) Storage method

Airtight container, stored at room temperature (1~30°C)