Topiramate Tablets (Topiramate)

Adult dose

It is advisable to start this medication at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this medication. The recommended dose of this medication applies to all adults and children, including older adults, provided they do not have kidney disease. This medication may be taken 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, consider the potential effect on seizure control. Unless other antiepileptic drugs must be stopped immediately for safety reasons, gradually taper them 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 medication may need to be reduced. 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 1- to 2-week intervals, administered in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the titration interval. The dose and rate of titration should be determined according to 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. 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 up to the maximum recommended dose of 800mg per day. 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- to 2-week intervals, administered in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller dose increments may be used or the titration interval may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this medication in the evening for the first week. Thereafter, increase the dose by 25mg/day at weekly intervals. If the patient has difficulty tolerating this titration, extend the titration interval. The recommended dose is 100mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. Doses up to 200mg per day may be administered; 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), reducing the starting and maintenance doses to approximately 1/2 is recommended. - Patients receiving hemodialysis: Because this medication is removed from plasma by hemodialysis, increase the dose of this medication by approximately 1/2 on dialysis days. Adjust the dose based on the duration of dialysis, the clearance of the dialysis equipment, and the patient's residual renal clearance, and administer the dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use this medication with caution in patients with hepatic impairment, as its clearance may be reduced.

Child dose

Children (6-16 years) During the first week, start treatment with 0.5-1 mg/kg in the evening. Thereafter, increase the dose by 0.5-1 mg/kg per day at intervals of 1-2 weeks, administering it twice daily. If the patient has difficulty tolerating dose increases, reduce the dose increments or increase the interval between increases. The dose and degree of dose increase should be determined according to the clinical response. The recommended dose for monotherapy in children is 3-6 mg/kg per day. In children diagnosed with partial seizures, doses of up to 500 mg per day have been used. Children (2-16 years) The recommended dose is approximately 5-9 mg/kg per day, divided into 2 doses. During the first week, administer 25 mg (or less, based on 1-3 mg/kg per day) in the evening; thereafter, increase the dose by 1-3 mg/kg per day at intervals of 1-2 weeks until an appropriate clinical effect is achieved, dividing the dose into 2 doses per day. Dose titration should be determined according to the clinical effect. Doses of up to 30 mg/kg per day have been used, and these were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors in patients taking it, so if there are any changes in mood or unusual behaviors while taking it, it is important to consult with healthcare professionals immediately. Additionally, there is a risk of sudden death in patients with epilepsy, and significant skin reactions may occur while taking this medication, so if any rashes or unusual symptoms develop, it is essential to stop using the drug immediately and consult with a doctor. Patients who are allergic to the ingredients of this medication or have certain genetic metabolic disorders should not take it, and pregnant women or women who may become pregnant should always conduct a pregnancy test before taking it; it should be used cautiously during pregnancy as it may harm the fetus. Patients with impaired kidney or liver function may experience delayed excretion of this medication, so dosage adjustment and monitoring are necessary, and adequate fluid intake is important for patients at risk of kidney stones. While taking this medication, symptoms such as drowsiness, dizziness, and blurred vision may occur, necessitating caution when driving or operating machinery, and in the event of discontinuation of the medication, gradual reduction is required to minimize the risk of seizures. This medication may interact with other drugs, so especially when taking it with other antiepileptic drugs, contraceptives, lithium, antihypertensives, etc., it is important to follow the healthcare provider's instructions. Pregnant and breastfeeding individuals should consult a specialist when taking this medication, as it may affect the fetus or newborn, and women of childbearing age should use effective contraception. Various side effects such as weight loss, decreased appetite, depression, and memory impairment may occur while taking this medication, so if any abnormal symptoms persist or worsen, it is important to inform healthcare professionals immediately. Finally, this medication can lower bicarbonate levels, leading to metabolic acidosis, so regular blood tests to monitor physical conditions during long-term use are recommended.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it is advisable to store it in a cool and dry place below 25 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a long time.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle