Topiramate Tablet 100 mg (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. 1. Epilepsy 1) Monotherapy 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 rate of dose escalation, extend the interval between increases. The dose and rate of escalation should be determined according to the 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 up to 1,000㎎ per day of topiramate monotherapy. 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 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 intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating dose increases, the dose increment may be reduced or the interval between increases extended. The dose should be determined according to the clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this medicine 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 interval between 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 to 200mg per day; the dose and rate of escalation should be determined according to the 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 starting and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. 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 Use with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at intervals of 1-2 weeks and administer it twice daily. If the patient has difficulty tolerating dose increases, reduce the dose increment or extend the interval between increases. The dose and degree of 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, 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 intervals of 1-2 weeks and administer it in 2 divided doses until an appropriate clinical effect is achieved. 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 medication may increase the risk of suicidal thoughts or behaviors, so patients should consult a physician immediately if they experience mood changes or depressive symptoms while taking it. Patients taking this medication should have their health status regularly monitored due to the risk of sudden death. If severe skin rashes or red spots, blisters, etc., appear, the use of this medication should be stopped immediately and healthcare personnel should be informed. Patients with allergies to any ingredient in this medication should not take it, and those who are lactose intolerant should also avoid it. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, as it may harm the fetus during pregnancy. Patients with impaired kidney function may need dosage adjustment as the rate at which the drug is eliminated from the body may slow down, so they should follow their physician's instructions. This medication is removed during hemodialysis, so dialysis patients may require dosage adjustments. There is a risk of kidney stones, so it is important to drink plenty of water and maintain adequate hydration. Patients with poor liver function should be cautious as the elimination of this medication may be delayed. If there are changes in weight while taking this medication, attention should be paid to dietary adjustments or nutritional supplementation. This medication can cause central nervous system side effects such as drowsiness, dizziness, and blurred vision, so caution should be taken when driving or operating machinery. There may be interactions with other medications, so if the patient is taking other medicines, they should inform their healthcare provider or pharmacist. In particular, women taking contraceptive pills should be aware that this medication may reduce contraceptive effectiveness, and additional contraceptive methods should be used. Abruptly stopping this medication may worsen seizures, so the dosage should be gradually reduced as directed by a physician. There is a risk of dehydration or increased body temperature while taking this medication, so caution should be exercised when active in hot environments. If there are changes in consciousness, severe headaches, changes in vision, or severe skin reactions while taking this medication, the patient should visit a medical institution immediately.

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering and should be kept in a cool, dry place below 25 degrees Celsius to maintain its effectiveness.

Appearance

Yellow, round, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle