Topiramate Tablet 100 mg (Topiramate)

Adult dose

Adults (17 years and older): Start with 25㎎ in the evening for the first 1 week. Thereafter, increase the dose by 25 or 50㎎ per day at intervals of 1-2 weeks and administer in 2 divided doses per day. If the patient has difficulty tolerating this titration schedule, lengthen the interval between dose increases. The dose and rate of titration 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 recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ per day. 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. Treatment is started with 25-50mg in the evening for the first 1 week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks and administer in 2 divided doses per day. If the patient has difficulty tolerating the increased dose, the dose increment may be reduced or the interval between dose increases may be extended. The dose should be determined according to the clinical effect. Adults: Start with 25mg of this medicine in the evening for the first 1 week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these dose increases, lengthen 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 up to 200mg per day, and the dose and rate of titration should be determined according to the clinical response. 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 undergoing hemodialysis: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer divided doses at the start and end of hemodialysis. 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 1 week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks and administer twice daily. If the patient has difficulty tolerating the increase, reduce the dose increment or extend the interval between increases. The dose and extent of titration should be determined according to the clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses up to 500㎎ per day have been used in children diagnosed with partial seizures. Children (2-16 years): The recommended dose is approximately 5-9mg/kg per day, administered in 2 divided doses. For the first 1 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, administering in 2 divided doses. Dose titration should be determined according to the clinical effect. Doses up to 30mg/kg per day have been administered and were generally well tolerated.

This medication can increase the risk of suicidal thoughts or behaviors, so it is crucial to monitor for mood changes or symptoms of depression during treatment. Patients taking this medication may have an increased risk of sudden death, although this is within the general risk range that can occur in epilepsy patients. Rarely, severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if abnormal skin symptoms develop, the medication should be discontinued immediately and medical advice should be sought. It should not be administered to individuals with hypersensitivity to its ingredients or certain genetically related lactose intolerant patients, and women who are pregnant or planning to become pregnant should take extra caution. Women who might become pregnant should take a pregnancy test before starting the medication and should ensure effective contraceptive methods are used during treatment. Patients with impaired renal or liver function may require dose adjustment, and patients undergoing hemodialysis need special management. This drug acts on the central nervous system and may cause symptoms like drowsiness, dizziness, or blurred vision; therefore, it is safer to avoid driving or operating machinery initially. Proper hydration is important, and caution should be taken as dehydration may increase the risk of kidney stones. Sudden discontinuation of this drug may worsen seizures, so when stopping, it should be done gradually under the guidance of a healthcare provider. Various side effects including weight loss, changes in appetite, and changes in mental state may occur during treatment; any abnormal symptoms should be reported to a healthcare provider. There may be interactions with other medications, so patients should inform their doctor or pharmacist about any other medications they are taking, particularly anticonvulsants, contraceptives, diabetes medications, or lithium preparations. Taking this drug during pregnancy may pose risks of malformation or growth restriction to the fetus, so consultation with a healthcare professional is imperative for women who are pregnant or planning to become pregnant. In lactating patients, this drug may be excreted in breast milk, so consultation with a healthcare provider regarding breastfeeding is warranted.

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

This medication may be sensitive to air or humidity, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius. Proper storage can help maintain the drug's efficacy and safety over time.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle