Topiramate Tablets 100mg (Topiramate)

Adult dosage

It is advisable to start this drug at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize the dosage of this drug. The recommended dosage of this drug applies to all adults and pediatric patients, including the elderly, in the absence of renal disease. This drug may be taken with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs 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 the other antiepileptic drugs 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 dose of this drug may need to be reduced. Adults (17 years and older): Start treatment with 25㎎ in the evening for 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 cannot tolerate this titration schedule, extend the intervals between dose increases. The dose and titration rate should be determined according to clinical response. The recommended dosage for adult monotherapy is 100～200mg daily. The maximum recommended dosage 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 dosage 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. Initiate 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 cannot tolerate the increased dose, smaller dose 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 treatment with 25mg of this drug in the evening during the first week. Thereafter, increase the daily dose by 25mg at weekly intervals. If the patient cannot tolerate this titration, extend the intervals 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 up to 200mg daily; the dose and titration rate 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 undergoing hemodialysis: Since this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Increase the dose taking into consideration the duration of dialysis, the clearance of the dialysis equipment, and the patient's residual renal clearance, and administer in divided doses at the beginning 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

Pediatric patients (6-16 years) Start treatment 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 cannot tolerate the dose increase, reduce the dose increment or extend the intervals between increases. The dose and titration should be determined according to clinical response. The recommended dosage for pediatric monotherapy is 3-6mg/kg daily. In pediatric patients diagnosed with partial seizures, doses up to 500㎎ daily have been used. Pediatric patients (2-16 years) The recommended daily dosage 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, and administer 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 seizures or migraines, and there may be an increased risk of suicidal thoughts or behavior during treatment. Patients should immediately inform their healthcare provider if they experience any changes in mood or behavior. Patients taking this medication should be monitored closely due to the risk of sudden death, and serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if a rash or blisters appear, use of the medication should be stopped immediately. Patients with a known allergy to this medication or specific genetic disorders such as lactose intolerance should not take it, and women who are pregnant or planning to become pregnant must consult a doctor before use, as it may harm the fetus and effective contraception methods should be utilized. Patients with reduced kidney or liver function may require dosage adjustments due to delayed drug elimination and should ensure adequate hydration to mitigate the risk of kidney stones. While taking this medication, side effects such as drowsiness, dizziness, and decreased concentration may occur, so caution should be exercised when driving or operating machinery. This medication may interact with other drugs, so it is essential to inform healthcare providers of any other medications being taken, especially when used with contraceptives, as contraceptive efficacy may be reduced. When discontinuing the medication, it should not be stopped abruptly but rather tapered off gradually under the guidance of a healthcare provider to reduce the risk of seizures. It is important to regularly consult healthcare providers while taking this medication and monitor for adverse reactions or changes in health status.

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

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it is important to store it at room temperature between 1 and 30 degrees Celsius to maintain its efficacy.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle