Topiramate Tablets 25 mg (Topiramate)

Adult dose

It is advisable to start this drug at a low dose and increase it to the effective dose. Monitoring blood levels is not necessary to optimize the administration of this drug. The recommended dose of this drug applies to all adults and children, including older adults, in the absence of renal disease. It may be administered 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 tapered by approximately 1/3 every 2 weeks (see “5. General precautions” under Precautions for use). When drugs that induce drug-metabolizing enzymes are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations occurs, the dose of this drug may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening during the first week. Thereafter, increase by 25 or 50㎎ per day at 1-2-week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, lengthen the interval between dose increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated up to 1,000㎎ daily of topiramate as monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg daily, and the usual dose is 200-400mg daily in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg daily. Start treatment with 25-50mg in the evening during 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 daily. If the patient has difficulty tolerating the increased dose, smaller dose 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 during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, lengthen the interval between dose increases. The recommended dose is 100mg daily, divided into 2 doses. Some patients may respond to a dose of 50mg daily. Doses of up to 200mg daily 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 initial and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Because this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer the additional dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment, as clearance of this drug may be reduced.

Child dose

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase by 0.5-1㎎/㎏ per day at 1-2-week intervals and administer twice daily. If the patient has difficulty tolerating dose increases, reduce the size of the increments or lengthen the intervals between increases. The dose and extent of titration should be determined according to clinical response. The recommended dose for pediatric monotherapy is 3-6mg/kg daily. Doses of up to 500㎎ daily have been used in children diagnosed with partial-onset seizures. Children (2-16 years): The recommended dose is approximately 5-9mg/kg daily, divided into 2 doses. During the first week, administer 25mg (or less, based on 1-3mg/kg daily) in the evening. Thereafter, increase by 1-3mg/kg daily at 1-2-week intervals until an appropriate clinical effect is achieved, and administer in 2 divided doses daily. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg daily have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors, so changes in mood or unusual behavior should be monitored closely during treatment. Patients taking this medication may experience sudden skin rashes or severe skin reactions; if skin abnormalities occur, use should be discontinued immediately and the medical staff should be notified. Taking this medication during pregnancy can cause harm to the fetus, so women of childbearing age should confirm their pregnancy status and use effective contraception without fail. Patients with impaired kidney function may have elevated concentrations of this drug in the body, so dosage should be adjusted and used cautiously. Adequate fluid intake is important while taking this drug to reduce the risk of kidney stone formation and maintain health. CNS side effects such as drowsiness, dizziness, and decreased concentration may occur during the initial stages of treatment or dosage adjustment, so it is advisable to avoid driving or operating machinery. This medication may interact with other antiepileptic drugs or medications; if other medications are being taken, medical staff must be informed. Discontinuing this medication abruptly can worsen seizures; therefore, the dosage should be gradually reduced when stopping use. Regular blood tests or kidney function tests are recommended during the use of this medication to check for adverse reactions. If changes in vision or eye pain occur while taking this medication, consult the medical staff immediately for appropriate action.

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

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. The appropriate storage temperature is in a cool place below 25 degrees Celsius, and it is best kept in a dry environment with low humidity.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle