Topiramate Tablet 25mg (Topiramate)

Adult dose

It is preferable to start this drug at a low dose and increase it to the effective dose. Monitoring of blood concentrations is not necessary to optimize treatment with this drug. The recommended dose of this drug applies to all adults and children, including the elderly, provided they do not have renal disease. It 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 effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually tapered and discontinued by approximately 1/3 every 2 weeks (see Precautions for Use, "5. General Precautions"). 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 with 25㎎ in the evening during the first week. Thereafter, increase the dose by 25 or 50㎎ per day at intervals of 1-2 weeks, administered 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 are determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated up to 1,000㎎ per day as topiramate monotherapy. 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 to the maximum recommended dose of 800mg per day. Start treatment with 25-50mg in the evening during the first week; a lower starting dose is also possible. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks, administered 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 effect. 2. Migraine prophylaxis 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 interval between dose 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 to 200mg per day; 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 initial and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Because this drug is removed from plasma by hemodialysis, the dose on dialysis days should be increased by approximately 1/2. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer the additional dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as clearance of this drug may be reduced.

Child dose

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks, administered twice daily. If the patient has difficulty tolerating the increase, reduce the increment or extend the interval between increases. The dose and degree of titration should be determined according to clinical response. The recommended dose for pediatric monotherapy 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. During the first 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, administered in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors, so any mood changes or symptoms of depression must be reported to a doctor immediately during treatment. Patients with epilepsy taking this medication may have a risk of sudden death, thus regular health monitoring is necessary. Severe skin reactions may occur, so if symptoms such as rash, blisters, or skin peeling arise, discontinue use immediately and consult a healthcare professional. Individuals with allergies to any components of this medication or those with genetic disorders such as lactose intolerance should not take this drug. Women of childbearing potential should confirm their pregnancy status before taking this medication and must use effective contraception during treatment. Taking this drug during pregnancy may harm the fetus, so those planning to become pregnant should discuss this with a doctor. Patients with impaired kidney or liver function may need to adjust the dosage of this medication, requiring careful management. Adequate hydration is important during treatment, and it is recommended to drink plenty of water to reduce the risk of kidney stones. This medication affects the central nervous system and may cause drowsiness, dizziness, and blurred vision; therefore, it is advisable to avoid driving or operating machinery during the initial period of use. Abrupt discontinuation may worsen seizures, so it is essential to gradually reduce the dosage as directed by a doctor. This medication may interact with other drugs, so if you are on other medications, inform your doctor or pharmacist. If you are taking contraceptives, this medication may reduce their effectiveness, so consult your healthcare provider if signs of bleeding or contraceptive failure occur. Changes in weight, mood, memory impairment, or loss of appetite may occur during treatment; if these symptoms persist, notify a healthcare professional. Pregnant or breastfeeding women should carefully consider the risks and benefits of taking this medication and consult a doctor about the effects of taking it during pregnancy on the fetus.

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

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it should be kept in a cool, dry place at or below 25 degrees Celsius to maintain its effectiveness.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle