Topiramate Extended-Release Tablets 25 mg (Topiramate)

Adult dose

It is advisable to start this medication at a low dose and increase it to the effective dose. Monitoring blood levels is not necessary to optimize treatment with this medication. The recommended dose applies to all adults and children, including older adults, without renal disease. This medication may be taken with or without food. This medication 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 other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually tapered and discontinued, reducing the dose by approximately 1/3 at 2-week intervals (see “5. General Precautions” under Precautions for Use). When an enzyme-inducing drug is 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 (17 years and older) Start with 25 mg in the evening for the first week. Thereafter, increase by 25 or 50 mg per day at 1-2 week intervals and administer once daily. If the patient has difficulty tolerating this titration schedule, extend the intervals between dose increases. The dose and rate of titration should be determined based on clinical response. The recommended dose for monotherapy in adults is 100～200 mg per day. The maximum recommended dose is 500 mg per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000 mg per day. 2. Adjunctive therapy - Adults (17 years and older) The minimum effective dose is 200 mg per day, and the usual dose is 200-400 mg per day administered once daily. Depending on the patient, the dose may be increased to the maximum recommended dose of 800 mg per day. Begin treatment with 25-50 mg in the evening for the first week; starting at a lower dose is also possible. 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, increase the dose by smaller increments or extend the interval between dose increases. 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), it is recommended to reduce the starting and maintenance doses to approximately 1/2. - Hemodialysis patients: Because this medication is removed from plasma by hemodialysis, hemodialysis patients should receive an additional dose on the day of dialysis equivalent to approximately 1/2 of the daily dose. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance. Divide the dose and administer it at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as clearance of this medication may be reduced.

Child dose

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

This medication may increase the risk of suicidal thoughts or actions; therefore, mood changes or symptoms of depression should be closely monitored during treatment. Patients taking this medication have reported an increased risk of sudden death, although this is within the general risk range that can occur in epilepsy patients. Patients with an allergy to any components of this medication should not take it, and those with reduced kidney function may require dosage adjustments due to the slow elimination of the drug from the body. Patients undergoing dialysis may need dosage adjustments as the drug may be significantly removed during dialysis. Adequate hydration is important to reduce the risk of kidney stones, and caution should be exercised when taking this medication in patients with impaired liver function. If changes in weight occur during treatment, patients should consider adjusting their dietary intake or nutritional supplementation. This medication affects the central nervous system, potentially causing drowsiness, dizziness, decreased concentration, and memory impairment, thus caution is warranted when driving or operating machinery. It is important to maintain adequate hydration during treatment to prevent kidney stones and dehydration. Taking this medication during pregnancy may increase the risk of fetal malformations or low birth weight; therefore, women of childbearing potential should use effective contraception, and decisions regarding use during pregnancy should be made in consultation with a healthcare provider. In lactating patients, this medication may pass into breast milk, so nursing status and medication use should be discussed with healthcare providers. This medication may interact with other drugs; if patients are currently taking any other medications, they must inform their healthcare provider, especially if combining with other antiepileptics or oral contraceptives. Severe symptoms may occur in cases of overdose, so it is essential to adhere to the prescribed dosage, and to contact medical facilities immediately if unusual symptoms arise. Keep out of reach of children, and avoid transferring the contents to other containers as this may result in accidents or deterioration of quality.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• hyperesthesia
• perceptual disturbances
• somnolence
• ataxia
• concentration impairment

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink round extended-release film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle