Topiramate 25 mg Tablet

Adult dosage

It is preferable to start this medication at a low dose and increase it to the effective dose. There is no need to monitor plasma concentrations to optimize the administration of this medication. The recommended dosage of this medication applies equally to all adults and children, including older adults, provided they do not have renal disease. This medication may be taken with or without food. Swallow the tablet whole; do not crush it. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, the potential effect on seizure control should be considered. Unless the other antiepileptic drug must be discontinued immediately for safety reasons, gradually reduce its dose by about 1/3 at 2-week intervals before discontinuing it (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 concentrations 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 1-2-week intervals and administer it in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the intervals between dose increases. 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 to the maximum recommended dose of 800mg per day. Begin 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 it in 2 divided doses per day. If the patient has difficulty tolerating an increased dose, a smaller dose increase 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 with 25mg of this medication in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend the intervals 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. 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. - Patients on hemodialysis: Because this medication is removed from plasma by hemodialysis, patients on hemodialysis should receive an approximately 1/2 increase in the dose 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 portions at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer this medication with caution to patients with hepatic impairment, as its clearance may be reduced.

Children's dosage

1. Epilepsy 1) Monotherapy — 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 1-2-week intervals and administer it in 2 doses per day. If the patient has difficulty tolerating an increase, reduce the increment or extend the interval between increases. The dose and extent of titration 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 seizures. 2) Adjunctive therapy — Children (2-16 years): The recommended dose is approximately 5-9mg/kg per day, 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 total daily dose by 1-3mg/kg at 1-2-week intervals until an appropriate clinical effect is achieved, and administer it in 2 divided doses per day. 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, careful observation is necessary for any mood changes or symptoms of depression while taking it. Patients taking this drug may face an increased risk of sudden unexpected death, though this falls within the general risk range observed in patients with epilepsy. Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur rarely, so any unusual skin symptoms should be reported to a healthcare professional immediately. Patients with allergies to the components of this drug or those with certain genetic lactose intolerance conditions should not take it. Women who are pregnant or may become pregnant should undergo pregnancy testing before taking this medication and use effective contraception during treatment. Pregnancy during treatment may harm the fetus, so it is crucial to consult with a doctor to decide on the use during pregnancy. Patients with impaired kidney function may require dosage adjustments as serum concentration may vary, and those undergoing hemodialysis should adjust the dosage according to dialysis conditions. Adequate hydration is crucial due to the risk of kidney stones, especially for patients with a history of kidney stones. Caution is also needed for patients with liver dysfunction when taking this medication. Weight changes may occur during treatment; thus, if there is a rapid increase or decrease in weight, dietary adjustments or supplements should be considered. As it can affect the central nervous system, symptoms such as drowsiness, dizziness, and impaired concentration may occur, so it is advisable to avoid driving or operating machinery during the initial period of use. This drug may interact with others; thus, patients should follow their doctor's advice, particularly when taking other antiepileptic drugs, contraceptives, lithium, or antihypertensive medications. Regular blood tests or liver and kidney function tests are necessary during treatment to check for abnormalities. Sudden discontinuation of this medication can increase seizures; hence, when stopping, it should be done gradually under a doctor's direction. Additionally, this medication may decrease sweating and raise body temperature, so attention is especially needed in hot environments, particularly for children. If consciousness changes, severe vomiting, or drowsiness occur, report it immediately to a healthcare professional for appropriate testing.

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

This medication should be stored in a tightly sealed container to be protected from air and moisture and kept in a cool, dry place below 25 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle