Jongkundang Topiramate Extended-Release Tablets 25 milligrams

Adult dose

It is preferable to start this medication at a low dose and increase it to the effective dose. Monitoring of blood levels is not necessary to optimize the dosage of this medication. The recommended dose of this medication applies to all adults and children, including older adults, provided they do not have renal disease. It may be taken with or without food. This medication is administered once daily. As this is an extended-release formulation, do not break, crush, or chew it. Swallow the tablet whole. 1. Monotherapy When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, the potential effects 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 “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 medication may need to be reduced. - Adults (aged 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, administered once daily. If the patient has difficulty tolerating this titration schedule, extend 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 100～200㎎ per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ per day. 2. Adjunctive therapy - Adults (aged 17 years and older) The minimum effective dose is 200㎎ per day, and the usual dose is 200-400㎎ per day administered once daily. Depending on the patient, the dose may be increased to the maximum recommended dose of 800㎎ per day. Start treatment with 25-50㎎ in the evening for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50㎎ at 1-2 week intervals, administered once daily. 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 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 starting and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Because this medication is removed from plasma by hemodialysis, patients on hemodialysis should receive an additional dose equivalent to approximately 1/2 of the daily dose on dialysis days. Adjust the dose based on the duration of dialysis, dialyzer clearance, and the patient’s renal clearance, and administer the dose in divided amounts at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Use this medication with caution in patients with hepatic impairment because its clearance may be reduced.

Child dose

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

This medication is an antiepileptic drug and may increase the risk of suicidal thoughts or behaviors, so careful observation for mood changes or suicidal impulses is advised during use. There is a risk of sudden death in epilepsy patients, so if any abnormal symptoms occur during treatment, consult a healthcare professional immediately. Patients with hypersensitivity to this medication should not take it, and those with impaired kidney or liver function may require dosage adjustments. Particularly, patients with reduced kidney function may have slower elimination of this drug, increasing the risk of side effects. Adequate hydration is crucial due to the risk of kidney stones, and patients should inform healthcare professionals if any kidney-related symptoms appear. This medication acts on the central nervous system and may cause drowsiness, dizziness, or blurred vision, necessitating caution while driving or operating machinery. During use, various adverse reactions such as weight changes, mood changes, depression, and memory impairment may occur, and if any abnormal symptoms appear, consultation with healthcare professionals is necessary. Taking this medication during pregnancy may affect the fetus, so women who plan to become pregnant or who are pregnant should consult professionals. During breastfeeding, this medication may be excreted in breast milk, so nursing women should also consult healthcare professionals regarding breastfeeding and medication use. There may be interactions with other medications, so it is important to inform healthcare professionals about any other medications being taken, especially other antiepileptic drugs, oral contraceptives, lithium, etc. Abruptly discontinuing this medication may worsen seizures, hence it should be tapered off gradually under the guidance of healthcare professionals. Overdose can lead to severe side effects, so strict adherence to dosing recommendations is essential, and if any abnormal symptoms occur, immediate medical attention should be sought. Store this medication out of reach of children and do not transfer to other containers for safety.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• hypersensitivity
• perceptual disturbances
• somnolence
• ataxia
• concentration/attention disorder

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. This will ensure the medication's effectiveness is preserved safely.

Appearance

Pink round extended-release film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle