Topiramate 25 mg (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood levels is not necessary to optimize treatment with this medicine. The recommended dose of this medicine is the same for all adults and children, including the elderly, in the absence of renal disease. May be administered with or without food. Swallow the tablet whole; do not crush it. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic medicines in order to administer topiramate as monotherapy, consider the possible effect on seizure control. Unless other antiepileptic medicines must be discontinued immediately for safety reasons, gradually reduce and discontinue them by approximately 1/3 at 2-week intervals (see “5. General Precautions” under Precautions for Use). When enzyme-inducing medicines 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 treatment with 25㎎ in the evening during the first week. Thereafter, increase by 25 or 50㎎ per day at 1-2 week intervals, administered in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and rate of increase should be determined according to clinical response. The recommended dose for adult monotherapy 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; 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 during the first week; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2 week intervals, administered in 2 divided doses. If the patient has difficulty tolerating the increased dose, a smaller dose increment may be used or the interval 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 medicine in the evening during the first week. Thereafter, increase by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this dose increase, extend the interval between 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 increase 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. - Hemodialysis patients: Since this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis equipment, and the patient's renal clearance, and administer the dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment, as the clearance of this medicine may be reduced.

Child dose

Children (6-16 years): Start treatment with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase by 0.5-1㎎/㎏ per day at 1-2 week intervals, administered twice daily. If the patient has difficulty tolerating the increase, reduce the increment or extend the interval between increases. The dose and extent of increase should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg daily. Doses up to 500㎎ daily have been used in children diagnosed with partial-onset seizures. 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 by 1-3mg/kg daily at 1-2 week intervals, administered in 2 divided doses, until an appropriate clinical effect is achieved. 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 as an antiepileptic drug for the prevention of epilepsy and migraines. There may be an increased risk of suicidal thoughts or behaviors while using this medication, so any signs of depression, mood changes, or suicidal thoughts should be reported to healthcare providers immediately during treatment. Moreover, serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur during treatment, so if symptoms such as skin rash, blisters, or mucosal damage appear, the use of this medication should be discontinued immediately, and medical attention should be sought. During pregnancy, there may be a risk of harm to the fetus, hence women who may become pregnant should take a pregnancy test before use and must employ effective contraception while taking the medication. Patients with impaired kidney or liver function may require dosage adjustments, as drug elimination may be delayed, and adequate hydration is important to reduce the risk of kidney stones. At the beginning of treatment or when changing the dosage, central nervous system side effects such as drowsiness, dizziness, and decreased concentration may occur, so caution should be exercised while driving or operating hazardous machinery. This medication may interact with other antiepileptic drugs or various medications, so it is essential to inform healthcare providers about any other medications being taken. Sudden discontinuation of the medication may worsen seizures, so discontinuation must be performed gradually under a physician's guidance. Finally, various side effects including weight loss, decreased appetite, mood changes, visual disturbances, and dyspepsia may arise during treatment, and if any abnormal symptoms persist or worsen, consultation with a specialist is recommended.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• perception abnormalities
• hypomania
• ataxia

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably in a cool, dry location at or below 25 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and prevents degradation.

Appearance

Pale green, round, film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle