Topiramate Tablets (Topiramate)

Adult dosage

It is preferable to start this drug at a low dose and increase it to the effective dose. There is no need to monitor plasma concentrations to optimize the dosage of this drug. The recommended dose of this drug applies to all adults and children, including the elderly, in the absence of renal disease. May be administered with or without food. 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, consider the potential impact 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 drugs that induce drug-metabolizing enzymes are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations occurs, the dose of this drug may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening during the first week. Thereafter, increase the daily dose by 25 or 50㎎ at intervals of 1-2 weeks and administer 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 daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ daily. 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 up to the maximum recommended dose of 800mg daily. Start treatment with 25-50mg in the evening during the first 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 daily. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the intervals between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this drug in the evening during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, extend the intervals between dose increases. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses up to 200mg daily may be administered; the dose and rate of titration 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 initial and maintenance doses be reduced to approximately 1/2. - Hemodialysis patients: Since this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on the day of dialysis. Increase the dose taking into consideration the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution in patients with hepatic impairment, as clearance of this drug may be reduced.

Children's dosage

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ 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 intervals between dose increases. The dose and degree of increase 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 up to 500㎎ daily have been used. Children (2-16 years): The recommended daily dose is approximately 5-9mg/kg, administered in 2 divided doses. During 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 intervals of 1-2 weeks until an appropriate clinical effect is achieved, administering in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg daily have been administered and were generally well tolerated.

This medication is used for the prevention of epilepsy and migraines and may increase the risk of suicidal thoughts or behaviors, so patients should be closely monitored during treatment. There is also a possibility of sudden death occurring in patients taking this medication, and serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so skin conditions should be closely observed. Patients with hypersensitivity to this medication or lactose intolerance should not take it, and women who are pregnant or planning to become pregnant should consult with a healthcare professional before taking it. Taking this medication during pregnancy may harm the fetus and increase the risk of preterm birth or low birth weight, so particular caution is required. Patients with impaired kidney function may have elevated drug concentrations in the body, requiring dose adjustments, and patients undergoing hemodialysis should adjust their dosage according to the dialysis schedule. This medication may affect the central nervous system, causing drowsiness, dizziness, or blurred vision, so caution is needed while driving or operating machinery. Sufficient hydration is important during treatment to reduce the risk of kidney stones, and patients should be encouraged to drink plenty of water. Neurological symptoms such as mood changes, depression, and decreased concentration may occur, and if these symptoms arise, patients should immediately inform their healthcare provider. This medication may interact with other antiepileptic drugs, so patients taking other medications should inform their healthcare provider, especially since dose adjustments may be necessary when taken with phenytoin or carbamazepine. Women taking oral contraceptives should consider using additional contraceptive methods, as this medication may affect contraceptive efficacy. Additionally, this medication may interact with certain diabetes medications, diuretics, lithium, etc., so if patients are taking other medications, they should definitely consult their healthcare provider. If sudden vision loss or eye pain occurs during treatment, patients should immediately stop taking the medication and seek medical attention, as this may indicate increased intraocular pressure or symptoms of glaucoma. This medication may cause various side effects, including weight loss, decreased appetite, fatigue, dizziness, nausea, diarrhea, rashes, and more, and patients should inform their healthcare provider if any symptoms persist or become severe. Patients should not abruptly stop the medication during treatment but should taper off gradually according to their healthcare provider's instructions, as sudden discontinuation may increase the risk of seizures. Pregnant or breastfeeding women should consult with their healthcare provider before taking this medication, and women planning to become pregnant should consider the use of this medication carefully.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• perceptual disturbances
• ataxia
• motor coordination issues

This medication should be stored in a tightly closed container to prevent exposure to air and moisture and should be kept in a cool, dry place at or below 25 degrees Celsius.

Appearance

White, round, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle