Topiramate Tablets (Topiramate)

Adult dosage

It is advisable to start this drug at a low dose and increase it to the effective dose. There is no need to monitor plasma concentrations to optimize administration of this drug. The recommended dose of this drug applies to all adults and children, including the elderly, in the absence of renal disease. This drug may be administered with or without food. Take 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 need to be stopped immediately for safety reasons, gradually reduce and discontinue the other antiepileptic drugs by approximately 1/3 at 2-week intervals (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 drug may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1-2-week intervals and administer in 2 divided 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 monotherapy in adults is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated up to 1,000㎎ per day of 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 for the first week; treatment may also be started at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2-week intervals and administer in 2 divided doses per day. If the patient has difficulty tolerating the increased dose, smaller increments 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 drug 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 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 titration rate 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 to reduce the starting and maintenance doses to approximately 1/2. - Hemodialysis patients: Since this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis machine, 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, as clearance of this drug 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 dose by 0.5-1㎎/㎏ per day at 1-2-week intervals and administer twice daily. If the patient has difficulty tolerating the dose increase, reduce the increment or extend the interval between increases. The dose and degree of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses of 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, and thereafter increase the dose by 1-3mg/kg per day 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 of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication can increase the risk of suicidal thoughts or behaviors, so if mood changes or unusual behaviors occur during treatment, it is essential to inform healthcare professionals immediately. There is a risk of sudden death in epilepsy patients taking this medication, so caution is necessary. Serious skin reactions may occur rarely; if a rash or blisters appear, the medication should be stopped immediately and medical consultation is required. Patients with known allergies to any ingredient in this medication should avoid taking it, and caution is also needed for patients with lactose intolerance. Women who are pregnant or planning to become pregnant must consult a doctor before taking this medication and should use effective contraception. Patients with reduced kidney or liver function may require dosage adjustments due to delayed elimination of the drug. Adequate hydration is needed during treatment, and patients are advised to drink plenty of water due to the risk of kidney stones. Due to possible central nervous system effects, caution should be taken when driving or operating machinery as drowsiness, dizziness, or decreased concentration may occur. Sudden discontinuation of this medication may worsen seizures, and it should be tapered off gradually under medical supervision. This medication may interact with other drugs, so patients should inform their healthcare provider of any other medications they are taking. If this medication is taken during pregnancy, there is an increased risk of birth defects or low birth weight, so its use during pregnancy should be carefully considered.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture, in a cool and dry place below 25 degrees Celsius. Proper storage will help maintain the drug's efficacy over time.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle