Topiramate Tablet 100 mg (Topiramate)

Adult dose

It is advisable to start this medication at a low dose and increase it to the effective dose. Monitoring blood levels is not necessary to optimize the dosage of this medication. The recommended dosage of this medication applies to all adults and children, including older adults, without renal impairment. It may be taken with or without food. Tablets should be swallowed whole and must not be crushed. 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 discontinued immediately for safety reasons, gradually reduce and discontinue them 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 dosage of this medication may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating this titration schedule, lengthen the intervals between dose increases. The dose and titration rate should be determined according to clinical response. The recommended dosage for monotherapy in adults is 100～200mg per day. The maximum recommended dosage is 500㎎ per day. Some patients with recurrent epilepsy have tolerated up to 1,000㎎ of topiramate per day as monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dosage is 200mg per day, and the usual dosage is 200-400mg per day in 2 divided doses. Depending on the patient, the dosage may be increased to the maximum recommended dosage of 800mg per day. Begin treatment with 25-50mg in the evening for the first week; starting at a lower dosage is also possible. Thereafter, increase the dosage by 25-50mg at intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating the increased dosage, smaller increments may be used or the intervals between increases may be extended. The dosage should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this medication in the evening for the first week. Thereafter, increase the daily dosage by 25mg at 1-week intervals. If the patient has difficulty tolerating these increases, lengthen the intervals between dose increases. The recommended dosage is 100mg per day, administered in 2 divided doses. Some patients may respond to a dosage of 50mg per day. The dosage may be increased to 200mg per day; the dose and titration rate should be determined according to clinical response. 3. Patients with renal impairment - For patients with moderate to severe renal impairment (CLcr < 70 mL/min/1.73 m2), it is recommended that the starting and maintenance dosages be reduced to approximately 1/2. - Hemodialysis patients: Because this medication is removed from plasma by hemodialysis, the dosage on dialysis days should be increased by approximately 1/2. Adjust the dose taking into account the duration of dialysis, the clearance of the dialysis machine, and the patient's renal clearance, and administer the dose in divided portions at the start and end of hemodialysis. 4. Patients with hepatic impairment Use this medication with caution in patients with hepatic impairment, as its clearance may be reduced.

Child dose

1. Epilepsy 1) Monotherapy Children (6-16 years) For the first week, start treatment with 0.5-1㎎/㎏ in the evening. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks and administer in 2 divided doses daily. If the patient has difficulty tolerating dose increases, reduce the increments or extend the intervals between increases. The dose and rate of increase 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. 2) Adjunctive therapy Children (2-16 years) The recommended daily dose is approximately 5-9mg/kg, 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 dose by 1-3mg/kg per day at intervals of 1-2 weeks until an appropriate clinical effect is achieved, administered in 2 divided doses daily. Dose titration should be guided by the clinical effect. Doses of up to 30mg/kg per day have been administered; these were generally well tolerated.

This drug may increase the risk of suicidal thoughts or behaviors, so if mood changes, depressive symptoms, or suicidal thoughts occur during use, you must consult a doctor immediately. Patients taking this medication are at risk of sudden death, especially those with epilepsy, therefore careful monitoring is required. Serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur rarely, so if severe rashes or blisters appear on the skin, you should stop taking the medication immediately and inform medical staff. This drug should not be administered to patients with hypersensitivity to it or with genetic issues such as lactose intolerance. Women who are pregnant or planning to become pregnant should definitely take a pregnancy test before taking this drug and should use effective contraception while taking it, as there is a risk of harming the fetus during pregnancy, and the decision should be made cautiously. Patients with decreased kidney function may have delayed drug excretion, so dosage adjustments and careful observation of side effects are required. This drug is removed during hemodialysis, so patients on dialysis should adjust the dosage according to dialysis conditions. Due to the risk of kidney stones, adequate fluid intake should be maintained to prevent kidney stone formation. Patients with reduced liver function may have slower metabolism of this drug, so it should be used cautiously. If weight loss or poor nutritional status occurs while taking this drug, dietary supplements or increased nutritional intake may be necessary. Caution is advised for tasks requiring alertness, such as driving or operating machines, until the individual response to the drug is confirmed, as drowsiness or dizziness may occur. This drug affects the central nervous system, potentially causing drowsiness, dizziness, blurred vision, etc., so caution should be exercised for activities if these symptoms appear. This drug may interact with other drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist. Especially women taking contraceptives should use additional contraceptive methods as this drug may reduce contraceptive effectiveness. When used with other antiepileptic drugs, changes in drug concentration may occur, so regular blood tests and adherence to the doctor's instructions are necessary. While taking this drug, a decrease in serum bicarbonate levels may lead to metabolic acidosis, so regular blood tests should be conducted to monitor the condition. Taking this drug may reduce sweating, making it difficult to regulate body temperature, so caution should be taken against dehydration and heat stroke in hot environments. This drug can cause hyperammonemia, so if sudden changes in consciousness or symptoms such as vomiting occur, inform medical staff immediately. During treatment, abnormal behavior, mood changes, and memory impairment may occur, so consult a doctor if these symptoms appear.

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

This drug should be stored in a well-sealed container to prevent air and moisture exposure, and it is advisable to keep it in a cool, dry place at or below 25 degrees. Care should be taken as the drug's efficacy may be diminished in humid areas or high temperatures.

Appearance

Yellow circular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle