Topiramate 25 mg (Topiramate)

Adult dosage

It is recommended that this medicine be started at a low dose and increased to the effective dose. Monitoring plasma concentrations is not necessary to optimize the dose of this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, who do not have kidney disease. It may be taken without regard to meals. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs to use topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, gradually reduce the dose of the other antiepileptic drug by approximately one-third at 2-week intervals until it is discontinued (see section 5, General Precautions, under Precautions for Use). When an enzyme-inducing drug is 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 with 25 mg in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50 mg at 1- to 2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating this rate of increase, extend the interval between increases. The dose and rate of increase 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 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 and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, the dose increase may be smaller or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start 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 increase, extend the interval between increases. 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 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. - Patients receiving hemodialysis: Since this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer the dose in divided amounts at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment because clearance of this medicine may be reduced.

Children's dosage

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1- to 2-week intervals and administer in 2 divided doses. 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 per day. Doses up to 500㎎ per day have been used in children diagnosed with partial-onset seizures. Children (2-16 years): The recommended dose is approximately 5-9mg/kg per day, administered in 2 divided doses. For the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening; thereafter, increase the total daily dose by 1-3mg/kg at 1- to 2-week intervals and administer 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 per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, patients should consult a doctor immediately if there are any mood changes or abnormalities in mental state while taking it. Patients with epilepsy taking this medication may have a risk of sudden death, so regular health monitoring is necessary. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if severe rashes or blisters appear on the skin, the medication should be discontinued immediately, and medical attention should be sought. Patients with allergies to any ingredients in this medication or with genetic issues such as lactose intolerance should not take it. Women who are pregnant or planning to become pregnant should take a pregnancy test before taking this medication and should use effective contraception during treatment, fully understanding the potential risks to the fetus. Patients with impaired kidney or liver function may experience delayed excretion of this medication; dosage adjustments and caution are required. This medication may increase the risk of urinary stones, so it is important to maintain adequate fluid intake. Central nervous system side effects such as drowsiness, dizziness, and blurred vision may occur; caution is advised when driving or operating machinery. This medication may interact with other drugs, so all medications being taken must be reported to and regularly monitored by a doctor or pharmacist. Abruptly stopping this medication may worsen seizures, so the dosage should be tapered off gradually according to a doctor's instructions. During treatment, symptoms of weight loss, loss of appetite, or depression may appear; consult medical personnel if abnormal symptoms occur. Administering this medication during pregnancy may pose risks of fetal malformation and low birth weight; decisions regarding administration should be made after consulting medical personnel during pregnancy. This medication may cause decreased sweating, leading to difficulties in temperature regulation, so special attention should be paid to temperature management, particularly for children or when exposed to hot environments. Hyperammonemia may occur; if symptoms such as drowsiness, vomiting, or changes in consciousness appear, medical personnel should be notified immediately.

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

Store this medication in a tightly closed container to prevent exposure to air or moisture. It is best kept in a cool, dry place at a temperature below 25 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle