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 concentrations is not necessary 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. 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, consider the potential effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, gradually taper and discontinue the other antiepileptic drugs by approximately 1/3 every 2 weeks (see “5. General Precautions” under Precautions for Use). When enzyme-inducing drugs that affect drug metabolism 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 by 25 or 50㎎ per day at 1-2-week intervals, administered in 2 divided doses daily. If the patient has difficulty tolerating this dose escalation, extend the interval between increases. The dose and rate of increase should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg/day. The maximum recommended dose is 500㎎/day. Some patients with recurrent epilepsy have tolerated up to 1,000㎎/day of topiramate monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg/day, and the usual dose is 200-400mg/day in 2 divided doses. Depending on the patient, the maximum recommended dose of 800mg/day may be administered. 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 daily. If the patient has difficulty tolerating the increased dose, increase by a smaller amount or extend the interval between increases. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start treatment with 25mg of this drug in the evening for the first week. Thereafter, increase by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this dose escalation, extend the interval between increases. The recommended dose is 100mg/day, administered in 2 divided doses. Some patients may respond to a dose of 50mg/day. Doses up to 200mg/day may be administered; the dose and rate of increase should be determined according to clinical response. 3. Patients with renal impairment - For patients with moderate and severe renal impairment (CLcr < 70 mL/min/1.73 m2), reducing the initial and maintenance doses to approximately 1/2 is recommended. - 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 considering the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer 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), monotherapy: Start with 0.5-1㎎/㎏ in the evening for 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 the increase, use smaller dose increments or extend the interval between increases. The dose and degree of increase should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg/day. Doses up to 500㎎/day have been used in children diagnosed with partial seizures. Children (2-16 years), adjunctive therapy: The recommended dose is approximately 5-9mg/kg/day, administered in 2 divided doses. For the first week, administer 25mg (or less, based on 1-3mg/kg/day) in the evening, and thereafter increase by 1-3mg/kg/day at 1-2-week intervals until an appropriate clinical effect is achieved, administered in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg/day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors, so any mood changes or unusual behaviors during treatment should be reported to a physician immediately. This medication may pose a risk of sudden death in epilepsy patients, hence careful observation is necessary during use. There is a possibility of serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if symptoms like skin rash or blisters occur, stop taking the medication immediately and inform your healthcare provider. Patients with a history of hypersensitivity to this medication or genetic conditions like lactose intolerance should not take it. Pregnant women or those planning to become pregnant should perform a pregnancy test before taking this medication and must use effective contraception during treatment, as it may harm the fetus. Caution is advised. Patients with impaired kidney or liver function may require dosage adjustments, and those undergoing dialysis should have their dosage adjusted according to dialysis conditions. Adequate hydration is necessary due to the risk of kidney stones, and those who have had kidney stones in the past should be especially cautious. During treatment, symptoms like drowsiness, dizziness, and blurred vision may occur, so caution is required when driving or operating machinery. This medication may interact with other drugs, so inform your doctor especially if you are taking antiepileptic drugs, contraceptives, lithium, or certain diabetes medications. While taking this medication, various adverse reactions such as weight changes, mood changes, depression, and memory impairment may occur, thus regular monitoring is needed. Discontinuing this medication suddenly may lead to an increase in seizures; therefore, dosage should be reduced gradually under the guidance of a healthcare provider. This medication may reduce sweating, affecting body temperature regulation; caution is especially needed for children or in hot environments. Encephalopathy associated with hyperammonemia may occur, so if sudden changes in consciousness or vomiting occur, seek medical attention immediately. Taking this medication during pregnancy poses risks of fetal malformation and growth retardation, so consult your physician before using.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be between 1 degree and 30 degrees Celsius, which helps maintain the medication's efficacy for a longer duration.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle