Seti Sustained-Release Tablets 50 mg (Topiramate)

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize treatment with this medicine. The recommended dose applies to all adults and children, including older adults, provided they do not have kidney disease. May be taken with or without food. This medicine is taken once daily. Because 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, consider the potential effect on seizure control. Unless another antiepileptic drug must be discontinued immediately for safety reasons, gradually taper it 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 medicine may need to be reduced. - Adults (17 years and older) Start with 25 mg in the evening for the first week. Thereafter, increase the daily dose by 25 or 50 mg at 1-2 week intervals and administer 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 based on clinical response. The recommended dose for monotherapy in adults is 100～200 mg daily. The maximum recommended dose is 500 mg daily. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000 mg daily. 2. Adjunctive therapy - Adults (17 years and older) The minimum effective dose is 200 mg daily, and the usual dose is 200-400 mg once daily. Depending on the patient, the dose may be increased to the maximum recommended dose of 800 mg daily. Start treatment with 25-50 mg in the evening for the first week; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50 mg at 1-2 week intervals and administer once daily. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the interval between dose increases may be extended. The dose 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), reducing the initial and maintenance doses to approximately 1/2 is recommended. - Patients on hemodialysis: Because this medicine 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 additional dose 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.

Child dose

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

This medication may increase the risk of suicidal thoughts or behavior, thus careful observation for mood changes or abnormal behavior during treatment is required. Patients with impaired renal function may take longer until the blood concentration of this drug stabilizes, so dosage adjustment may be necessary. Patients undergoing hemodialysis should adjust the dosage of this drug according to dialysis conditions. Patients who are prone to kidney stones or have a family history of kidney stones may have an increased risk of kidney stones when taking this medication, so adequate water intake is necessary. Patients with impaired liver function should also use this medication with caution. If there are changes in weight during treatment, it may be necessary to adjust the food intake or consider supplements. This medication can cause a variety of side effects related to the nervous system and mental health, including drowsiness, dizziness, memory impairment, mood changes, and loss of appetite, so if symptoms occur, consult healthcare professionals. Caution is advised when driving or operating machinery, especially when starting treatment or adjusting dosage. Adequate water intake is needed with this medication; due to decreased sweating, there is a risk of elevated body temperature in hot environments, so special care should be taken. Taking this medication during pregnancy may pose a risk of birth defects, so women of childbearing potential should definitely consult a physician and ensure appropriate contraception. Breastfeeding may lead to this medication being excreted in breast milk, so discuss breastfeeding with healthcare professionals. This medication may interact with other drugs, so it is essential to inform your healthcare provider of any other medications you are taking, especially when combined with antiepileptics, oral contraceptives, lithium, or diabetes medications. Stopping this medication suddenly can worsen seizures, so it should be gradually tapered under a physician's guidance. In case of overdose, symptoms may include headache, seizures, drowsiness, and confusion, requiring immediate medical attention.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is safe to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage maintains the drug's efficacy and safety.

Appearance

Pink round sustained-release film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle