Topiramate 100 mg Tablet

Adult dose

It is preferable to start this drug at a low dose and increase it to the effective dose. It is not necessary to monitor plasma concentrations to optimize treatment with this drug. The recommended dose of this drug is the same for all adults and children, including elderly patients, who do not have renal disease. It may be administered with or without food. The tablets should be swallowed whole without crushing. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, the possible 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 1/3 every 2 weeks (see section 5. General Precautions under Precautions for Use). When drugs that induce drug-metabolizing enzymes 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): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1-2 week intervals, administered in 2 divided doses daily; if the patient has difficulty tolerating this titration schedule, extend the intervals between dose increases. The dose and titration rate 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 relapsed 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, the dose may be increased up to the maximum recommended dose of 800mg per day. Initiate treatment with 25-50mg in the evening for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer it in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, a smaller dose increase may be made or the interval between dose increases may be extended. The dose should be determined according to clinical response. 2. Prevention of migraine 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 these increases, 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. 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 starting and maintenance doses be reduced to approximately 1/2. - Hemodialysis patients: 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 in hemodialysis patients. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis equipment, 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 This drug should be administered with caution to patients with hepatic impairment, as its clearance may be reduced.

Child dose

Children (6-16 years): During the first week, initiate treatment at 0.5-1㎎/㎏ in the evening. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at 1-2 week intervals and administer in 2 divided doses. If the patient has difficulty tolerating dose increases, reduce the increment or extend the interval between increases. The dose and degree of dose escalation should be determined according to the clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses of up to 500㎎ per day have been used in children diagnosed with partial seizures. Children (2-16 years): The recommended daily dose is approximately 5-9mg/kg, divided into 2 doses. During the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening. Thereafter, increase the 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 the clinical effect. Doses of up to 30mg/kg per day have been administered, and were generally well tolerated.

This drug may increase the risk of suicidal thoughts or suicide attempts, so mood or behavior changes should be carefully monitored during treatment. Patients with epilepsy who take this medication may be at risk of sudden death, so regular health status checks are necessary. Rarely, serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if any unusual skin symptoms appear, treatment should be stopped immediately, and medical advice should be sought. Patients with an allergy to this drug or those with certain genetic lactose intolerance should not take it. Women who are pregnant or planning to become pregnant must consult a physician before taking this drug and should use effective contraception during treatment. Patients with poor kidney or liver function may require dose adjustments, and in the case of patients receiving dialysis, the dosage should be adjusted according to the dialysis requirements. This drug can increase the risk of kidney stones, so adequate hydration is very important. Drowsiness, dizziness, and blurred vision may occur during treatment, so caution is needed when driving or operating machinery. This drug can interact with other medications, so patients should inform their healthcare provider of any other medications they are taking. Sudden discontinuation of the medication may worsen seizures, so dosage should be gradually reduced according to medical advice.

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

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it should be stored in a cool, dry place below 25 degrees Celsius to maintain its effectiveness.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle