Topamate 25 mg (Topiramate)

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize administration of this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, provided they do not have renal disease. This medicine may be administered with or without food. Swallow tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy Adults (17 years and older): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1-2 week intervals and administer in 2 divided doses daily. 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 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 of 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 for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, the dose increase may be smaller or the titration interval 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 for the first week. Thereafter, increase the dose by 25mg/day at 1-week 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), it is recommended that the starting and maintenance doses be reduced to approximately 1/2. - Hemodialysis patients: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on the day of dialysis. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis device, 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 clearance of this medicine may be reduced.

Child dose

Children (6-16 years): Start treatment with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at 1-2 week intervals and administer twice daily. If the patient has difficulty tolerating the increase, reduce the size of each dose increase or extend the titration interval. 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-onset seizures. Children (2-16 years): The recommended daily dose is approximately 5-9mg/kg, administered in 2 divided doses. Administer 25mg (or less, based on 1-3mg/kg per day) in the evening during the first week; thereafter, increase the dose by 1-3mg/kg per day at 1-2 week intervals 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 per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors, so any appearance of depression or mood changes during treatment should be reported to healthcare professionals immediately. Additionally, sudden death may occur in epilepsy patients, thus regular health status checks are necessary. Serious skin reactions may occur during treatment; if rashes or blisters develop, the patient must stop taking the medication immediately and visit a hospital. This medication should not be used in patients with allergies to its components or in individuals with certain hereditary lactose intolerance. Women of childbearing potential should take a pregnancy test before starting this medication and should use effective contraception during treatment, as it can be harmful to the fetus if taken during pregnancy. Patients with impaired kidney or liver function may require dosage adjustments, and adequate hydration is important due to the risk of kidney stones. This medication can affect the central nervous system and may cause symptoms such as drowsiness, dizziness, and blurred vision; thus, caution should be exercised when driving or operating machinery after taking it. During treatment, patients should be carefully monitored for unusual symptoms such as weight changes, appetite changes, and mood changes. Abruptly stopping this medication can worsen seizures; dosage should therefore be tapered gradually under medical supervision. Moreover, it may interact with other medications; patients should inform healthcare providers of any other drugs they are currently taking, particularly contraceptives, lithium, and diabetes medications. Finally, regular blood tests and health checks should be conducted during treatment, and immediate consultation with a specialist should be sought if any abnormal symptoms occur.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• paresthesia
• delirium
• ataxia

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, it should be kept in a cool, dry place at a temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle