Topiramate XR 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) receiving monotherapy: 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) receiving adjunctive therapy: 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 is used for the treatment of epilepsy and migraine prevention and may increase the risk of suicidal thoughts or behaviors during treatment, requiring careful monitoring of changes in mental state. If depression, mood swings, or abnormal behavioral changes occur during treatment, inform your healthcare provider immediately. Dosage adjustments are necessary for patients with impaired kidney function as the drug is eliminated slowly from the body, and patients undergoing dialysis should adjust the dosage based on dialysis conditions. Ensure sufficient fluid intake due to the risk of kidney stones, and take extra caution if there is a history of kidney stones or family history. Patients with decreased liver function should also take this medication cautiously, and dietary adjustments may be necessary with changes in body weight. This medication may cause drowsiness, dizziness, fatigue, memory impairment, poor appetite, and various side effects, which require caution when driving or operating machinery. Neurological symptoms such as confusion, depression, aggression, and anxiety may occur; consult your healthcare provider if these abnormal symptoms persist. The use of this medication during pregnancy may increase the risk of fetal malformations, so women who are pregnant or planning to become pregnant should discuss it with their doctor. It may also be secreted into breast milk, so nursing mothers should discuss medication use with their healthcare provider. This medication may interact with other antiepileptic drugs, oral contraceptives, and diabetes medications, so inform your doctor of any other medications you are taking. Sudden discontinuation of the medication may worsen seizures, so withdrawal should be done gradually under medical supervision. In case of overdose, symptoms such as headache, convulsions, drowsiness, and coma may occur, and emergency treatment should be sought immediately. The safety and efficacy of this medication have not been established in children under 2 years of age, so its use is not recommended. This medication should be kept out of reach of children and not transferred to other containers.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• hypersensitivity
• perceptual disturbances
• drowsiness
• ataxia
• attention impairment

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain room temperature between 1 degree and 30 degrees Celsius to preserve the effectiveness and safety of the medication.

Appearance

Pink, round, sustained-release film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle