Topiramate Tablet 100 mg (Topiramate)

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize administration of this medicine. The recommended dose of this medicine applies to 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 and not crushed. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, the potential 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 one-third 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 dose of this medicine may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening for the first week. Thereafter, increase the daily dose by 25 or 50㎎ at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for monotherapy in adults is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated up to 1,000㎎ of topiramate daily as monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg daily, and the usual dose is 200-400mg daily in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg daily. Start 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 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 increases may be extended. The dose should be determined according to clinical response. 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 dose increases. The recommended dose is 100mg daily, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. The dose may be increased to 200mg daily; the dose and rate of titration should be determined according to 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 receiving hemodialysis: Because this medicine is removed from plasma by hemodialysis, the dose should be increased by approximately 1/2 on dialysis days. The dose should be increased taking into account the duration of dialysis, the clearance of the dialysis equipment, and the patient's renal clearance, and should be administered in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use this medicine with caution in patients with hepatic impairment, as its clearance may be reduced.

Child dose

Children (6-16 years), monotherapy: Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at 1-2 week intervals and administer in 2 doses daily. If the patient has difficulty tolerating the increase, reduce the size of the dose increment or extend the interval between increases. The dose and extent of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg daily. In children diagnosed with partial seizures, doses of up to 500㎎ daily have been used. Children (2-16 years), adjunctive therapy: The recommended dose is approximately 5-9mg/kg daily, administered in 2 divided doses. For the first week, administer 25mg (or less, based on 1-3mg/kg daily) in the evening; thereafter, increase the daily dose by 1-3mg/kg at 1-2 week intervals until an appropriate clinical effect is achieved, and administer in 2 divided doses daily. Dose titration should be determined according to clinical response. Doses of up to 30mg/kg daily have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors, so if mood changes or feelings of depression occur during treatment, consult a doctor immediately. Patients taking this medication may experience sudden death, so it is important to regularly check the condition under a physician's guidance. This medication can cause serious skin reactions; if a rash or blisters occur, discontinue use immediately and inform healthcare professionals. Patients allergic to any ingredient in this medication should not take it. Patients with lactose intolerance or specific genetic metabolic disorders should not take this medication. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, as it can harm the fetus during pregnancy. Women of childbearing age should use effective contraception while taking this medication. Patients with impaired kidney function should adjust the dosage according to a doctor's instructions, as the concentration of this medication in the body may change. Patients undergoing dialysis may need to adjust the dosage according to dialysis conditions. This medication is excreted through the kidneys, so adequate fluid intake is necessary to reduce the risk of kidney stones and other issues. Patients with decreased liver function should also exercise caution when taking this medication. If there are any weight changes during treatment with this medication, nutritional status should be checked, and dietary adjustments may be necessary. This medication may cause drowsiness, dizziness, or blurred vision as central nervous system side effects, so it is advisable to avoid driving or operating machinery in the early stages of treatment. This medication may interact with other drugs; inform your doctor or pharmacist of any other medications being taken. Particularly, caution is needed when taking this medication with contraceptives, as the contraceptive effect may be reduced. Stopping this medication suddenly can worsen seizures, so dosage should be gradually reduced according to a doctor's instructions when discontinuing. Regular blood tests and kidney and liver function tests are recommended during treatment with this medication. If any unusual symptoms or side effects occur while taking this medication, consult healthcare professionals immediately.

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

This medication should be stored in a tightly sealed container as it can be sensitive to air and moisture. Additionally, store it in a cool, dry place below 25 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle