Topiramate 25 mg Tablets

Adult dosage

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize the dose of this medicine. It may be administered 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, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be tapered and discontinued gradually, by approximately 1/3 every 2 weeks (see Precautions for Use, section 5, General Precautions). 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 with 25㎎ in the evening during the first week. Thereafter, increase the 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 titration rate 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 topiramate monotherapy at doses up to 1,000㎎ daily. 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; treatment may also be started 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 the increased dose, smaller increments or longer intervals between increases may be used. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start 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 increases. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses up to 200mg daily may be administered; the dose and rate of increase should be determined according to clinical response. 3. Patients with renal impairment - In 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. - Hemodialysis patients: Because this medicine is removed from plasma by hemodialysis, the dose should be increased by approximately 1/2 on dialysis days. The dose should be increased taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administered in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment because clearance of this medicine may be reduced.

Children's dosage

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

This medication may increase the risk of suicidal thoughts or behavior; therefore, if depression or mood changes occur during treatment, consult a physician immediately. There is a risk of sudden death in patients with epilepsy, so it is important to regularly check the health status during treatment. Serious skin rashes or allergic reactions may occur; if there are any signs of skin problems, cease medication immediately and inform healthcare personnel. Patients with allergies to any ingredient in this medication or those with certain genetic lactose intolerance should not use this medication. Women who are pregnant or planning to become pregnant should consult a physician before using this medication and must use effective contraception, as it may harm the fetus. Patients with weakened kidney or liver function need to adjust the dosage carefully, and for those undergoing dialysis, the dose should be adjusted according to dialysis conditions. During treatment, adequate hydration is necessary, and drinking plenty of water is recommended to reduce the risk of kidney stones. Central nervous system side effects such as drowsiness, dizziness, and blurred vision may occur; caution is needed when driving or operating machinery. Abruptly discontinuing this medication may worsen seizures, so it should be reduced gradually under a physician's supervision. Since this medication may interact with other drugs, inform your healthcare provider about any medications being taken, especially when used with antiepileptic drugs, contraceptives, diabetes medications, and diuretics. Side effects such as weight loss, loss of appetite, depression, memory impairment, and fatigue may occur; if symptoms persist or worsen, consult a physician. If a pregnant woman takes this medication, there is a risk of congenital defects and fetal growth restriction; its use during pregnancy should only be under a physician's judgment when absolutely necessary.

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

This medication should be stored in a tightly sealed container to prevent moisture and air exposure. Maintain the storage temperature at or below 25 degrees Celsius, keeping it in a dry and low-humidity environment.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle