Topiramate Tablet 25 mg (Topiramate)

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. The recommended dose of this medicine applies equally to all adults and children, including elderly patients, provided they do not have renal disease. Adults (17 years and older): Start with 25㎎ in the evening for the first week. Thereafter, increase the daily dose by 25 or 50㎎ at 1-2 week intervals and administer 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. The minimum effective dose in adults (17 years and older) 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 up 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 in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the intervals between dose increases may be extended. The dose should be determined according to clinical effect. 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 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 of up to 200mg per day may be administered; the dose and rate of titration should be determined according to clinical response. 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: Since this medicine is removed from plasma by hemodialysis, increase the dose by approximately 1/2 on dialysis days. Adjust the dose based on the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer divided doses at the beginning and end of hemodialysis.

Child dose

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at 1-2 week intervals and administer in 2 divided doses. If the patient has difficulty tolerating the increase, use smaller increments or extend the intervals between dose 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. 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, then increase the daily dose by 1-3mg/kg at 1-2 week intervals until an appropriate clinical effect is achieved, administering 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 is an anti-epileptic drug that may increase the risk of suicidal thoughts or behaviors in patients taking it. Therefore, patients should be closely monitored for these symptoms or mood changes during treatment. The risk of sudden death in patients with epilepsy may be slightly higher than in healthy individuals, but this is similar to the risk posed by the epilepsy itself. Additionally, serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis may occur rarely, so if any skin abnormalities occur, usage should be stopped immediately. Patients with a known allergy to any components of this medication or genetic issues such as lactose intolerance should not take it. Women who are pregnant or planning to become pregnant must consult a doctor before taking this medication, as it can harm the fetus during pregnancy and should be used with caution. Patients with impaired kidney or liver function will need dosage adjustments, and those undergoing dialysis should adjust their doses according to the dialysis conditions. Adequate hydration is necessary while taking this medication, and care must be taken to reduce the risk of kidney stone formation. Central nervous system symptoms such as drowsiness, dizziness, and decreased concentration may occur, so caution is needed when driving or operating machinery. Furthermore, this medication may interact with other drugs, so if you are taking other medications, it is essential to inform your healthcare provider. Dosage discontinuation should be gradually tapered to reduce the risk of seizures; abrupt cessation should be avoided. Weight loss, lack of appetite, depression, and memory impairment can occur while taking this medication. It must be used with extreme caution in pregnant women as it increases the risk of congenital malformations, low birth weight, and preterm birth. It is important to consult healthcare professionals immediately if any abnormal symptoms occur during the treatment.

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

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle