Topiramate 25 mg Tablet

Adult dosage

It is preferable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor blood concentrations to optimize the administration of this medicine. The recommended dose of this medicine applies equally to all adults and children, including older adults, in the absence of renal disease. This medicine may be taken with or without food. The 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, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually reduced and discontinued by about 1/3 every 2 weeks (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 concentration occurs, the dose of this medicine 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, 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 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. Treatment is started with 25-50mg in the evening for 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 dose increases, smaller increments may be used or the intervals between increases may be extended. The dose should be determined according to clinical response. 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 these increases, 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. Doses of 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: Since this medicine is removed from plasma by hemodialysis, the dose should be increased by approximately 1/2 on dialysis days. The dose should be adjusted taking into account the duration of dialysis, the clearance of the dialysis equipment, and the patient's residual renal clearance, and should be divided between the start and end of hemodialysis. 4. Patients with hepatic impairment This medicine should be administered 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, administered in 2 divided doses. If the patient has difficulty tolerating the dose increase, use smaller increments 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. In children diagnosed with partial seizures, doses of up to 500㎎ per day have been used. 2) Adjunctive therapy 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 1-2 week intervals until an appropriate clinical effect is achieved, administered in 2 divided doses. Dose titration should be determined according to clinical response. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication is used for the prevention of epilepsy and migraines and may increase the risk of suicidal thoughts or behaviors. Therefore, if mood changes or unusual behavior occurs, medical staff must be notified immediately. There is also a possibility of sudden death during the use of this medication, and serious skin reactions can occur rarely; if symptoms such as rash, blisters, or peeling skin appear, medication should be stopped immediately and medical attention sought. Patients with allergies to the ingredients or specific genetic lactose intolerance should not take this medication, and women who are pregnant or may become pregnant must consult a physician and use effective contraception. Patients with impaired kidney or liver function may experience delayed excretion of this medication, requiring dose adjustments, and patients undergoing hemodialysis should adjust their dosage according to dialysis conditions. Adequate hydration is important during use; extra caution should be taken to reduce the risk of kidney stones. This medication affects the central nervous system, possibly causing drowsiness, dizziness, or blurred vision, so caution should be exercised when driving or operating machinery. Weight changes, appetite loss, depression, anxiety, or other mental symptoms may occur during use, and if symptoms worsen, consultation with medical staff is necessary. This medication can interact with other drugs, so it is essential to inform the physician or pharmacist of any other medications taken. Using this medication during pregnancy may pose risks such as congenital malformations or growth retardation in the fetus, so individuals planning pregnancy or who are pregnant must consult medical staff. Stopping this medication suddenly may exacerbate seizures, so the dosage should be gradually reduced as directed by a physician.

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

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

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle