Topiratame Tablets 100 mg (Topiramate)

Adult dosage

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including the elderly, in the absence of renal disease. This medicine may be taken with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic drugs must be stopped immediately for safety reasons, they should be gradually reduced and discontinued by approximately 1/3 every 2 weeks (see “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 treatment with 25㎎ in the evening during the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at 1-2-week intervals, divided into 2 doses per day. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and titration rate 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 doses of up to 1,000㎎ per day as 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. Begin treatment with 25-50mg in the evening during the first week; a lower starting dose may also be used. Thereafter, increase the dose by 25-50mg at 1-2-week intervals, divided into 2 doses per day. 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 effect. 2. Prevention of migraine Adults: Start treatment with 25mg of this medicine in the evening during 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, divided into 2 doses. Some patients may respond to a dose of 50mg per day. The dose may be increased to 200mg per day, with the dose and rate of titration 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 medicine is removed from plasma by hemodialysis, the dose of this medicine should be increased by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's residual clearance, and administer the dose in divided portions at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Children's dosage

1. Epilepsy 1) Monotherapy Children (6-16 years): Start treatment with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1-2-week intervals, administered in 2 doses per day. If the patient has difficulty tolerating the increase, use smaller increments or extend the intervals between increases. 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. 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. During 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, divided into 2 doses per day. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts, behavior, or impulses in patients taking it. Therefore, patients should be carefully monitored for symptoms of depression, mood changes, or unusual behaviors during treatment. This medication may also increase the risk of sudden death in patients with epilepsy, necessitating thorough monitoring of the patient's condition during treatment. Serious skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur while taking this medication; thus, any skin abnormalities should be immediately reported to a healthcare provider. Patients with allergies to any components of this medication should not take it. Additionally, since this medication contains lactose, it should not be taken by patients with lactose intolerance or related genetic disorders. Women who are pregnant or may become pregnant should take a pregnancy test before taking this medication and should use effective contraception during treatment. Use during pregnancy may cause harm to the fetus and may result in low birth weight or growth restrictions; therefore, caution is advised. Patients with impaired renal function may experience delayed elimination of this medication, necessitating dose adjustments. Patients undergoing hemodialysis should adjust the medication dose according to dialysis conditions. This medication may increase the risk of kidney stones, so adequate hydration is crucial. Patients with liver dysfunction should also use this medication cautiously. It can cause central nervous system side effects such as drowsiness, dizziness, and decreased concentration; therefore, patients should avoid driving or operating machinery during the initial stages of treatment. Furthermore, there may be interactions with other medications; thus, any concurrent medications should be reported to a healthcare provider. It is advisable to consult a healthcare provider if there are significant changes in weight or appetite while taking this medication. Discontinuing this medication suddenly may worsen seizures; thus, it should be tapered off gradually under medical supervision. Finally, it's important to undergo regular examinations and monitoring during treatment to check for adverse reactions.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, maintaining a storage temperature between 1°C and 30°C. This ensures the preservation of the medication's efficacy and prevents degradation.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle