Topiramate 25 mg Tablets (Topiramate)

Adult dosage

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring of blood levels is not necessary to optimize the administration of this medicine. The recommended dose of this medicine applies to all adults and children, including the elderly, provided they do not have renal disease. This medicine may be taken 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, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually reduced and discontinued by approximately 1/3 every 2 weeks (see Precautions for Use, “5. General Precautions”). When a drug that induces drug-metabolizing enzymes is discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations occurs, the dose of this medicine may need to be reduced. Adults (17 years and older): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase the daily dose by 25 or 50㎎ at 1-2 week intervals, administered in 2 divided doses per day; if the patient has difficulty tolerating this titration schedule, extend the intervals between dose increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for monotherapy in adults is 100～200mg 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 (17 years and older) The minimum effective dose is 200mg per day, and the usual dose is 200-400mg per day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg per day. 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, administered in 2 divided doses per day. If the patient has difficulty tolerating the increased dose, smaller dose increments may be used or the intervals between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Begin treatment with 25mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend the intervals between dose increases. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. Doses up to 200mg per day may be administered; the dose and rate of titration 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 that the initial and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Because this medicine is removed from plasma by hemodialysis, the dose of this medicine should be increased by approximately 1/2 on dialysis days. The dose should be increased taking into consideration the duration of dialysis, the clearance of the dialysis equipment, and the patient's renal clearance, and should be divided between the start and end of hemodialysis. 4. Patients with hepatic impairment This medicine should be administered with caution in patients with hepatic impairment because its clearance may be reduced.

Children's dosage

Children (6–16 years): During the first week, begin with 0.5-1㎎/㎏ in the evening. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1-2 week intervals and administer in 2 divided doses. If the patient has difficulty tolerating dose increases, reduce the size of each increase or extend the interval between increases. The dose and rate of increase should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses of up to 500㎎ per day have been used in children diagnosed with partial seizures. Children (2–16 years): The recommended daily dose is approximately 5-9mg/kg, administered in 2 divided doses. During the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening. Thereafter, increase the total daily dose by 1-3mg/kg at 1-2 week intervals until an appropriate clinical effect is achieved, administering the dose in 2 divided doses. Dose titration should be based on clinical effect. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication is used for epilepsy and migraine prevention, and it may increase the risk of suicidal thoughts or behaviors. Therefore, patients and caregivers should immediately inform a physician of any changes in mood or unusual behavior. Additionally, there may be sudden skin rashes or severe skin reactions while taking this medication; if any skin symptoms occur, discontinue use immediately and consult a healthcare professional. This medication can be harmful to the fetus during pregnancy; therefore, women of childbearing potential should take a pregnancy test before taking this medication and must utilize effective contraceptive methods during treatment. Patients with impaired kidney function may have increased drug concentrations, so the dosage should be adjusted according to a physician's instructions; for patients undergoing dialysis, the dosage should be adjusted based on dialysis conditions. Sufficient fluid intake is crucial during treatment; it is recommended to drink water frequently to reduce the risk of kidney stones. This medication can cause central nervous system side effects such as drowsiness, dizziness, and blurred vision, so it is safest to avoid driving or operating machinery during the initial stages of treatment. Weight changes may occur during treatment; if weight decreases or increases dramatically, consult a physician. Furthermore, this medication may interact with other antiepileptic medications or various other drugs; if you are taking other medications, be sure to inform your healthcare professional. A sudden discontinuation of this medication may worsen seizures, so if discontinuation is necessary, it should be tapered off gradually under a physician's guidance. Lastly, this medication may cause mental health issues such as depression, anxiety, or reduced concentration; if there are any changes in mental state, immediately consult a healthcare professional.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• perceptual distortion
• confusion
• ataxia

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It should be kept in a cool, dry place below 25 degrees Celsius for optimal efficacy.

Appearance

White, round, film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle