Topamax Sprinkle Capsules 25 mg (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize administration of this medicine. The recommended dose of this medicine applies to all adults and children, including the elderly, in the absence of renal disease. It may be administered with or without food. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic medicines in order to administer topiramate as monotherapy, the potential effect on seizure control should be considered. Unless other antiepileptic medicines must be discontinued immediately for safety reasons, gradually reduce and discontinue the other antiepileptic medicines by approximately 1/3 at 2-week intervals (see Precautions for Use, “5. General Precautions”). When medicines that induce drug-metabolizing enzymes are 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 dose by 25 or 50㎎ per day at 1-2 week intervals and administer in 2 divided doses daily; if the patient has difficulty tolerating this titration schedule, lengthen the interval between dose increases. The dose and rate of increase 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 up to 1,000㎎ of topiramate per day as monotherapy. 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. Start treatment with 25-50mg in the evening during the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, increase by a smaller amount or extend the interval between dose increases. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start treatment with 25mg of this medicine in the evening during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, lengthen the interval 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. The dose may be increased to 200mg per day, and the dose and rate of increase 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 medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and divide the dose between the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment because clearance of this medicine may be reduced.

Child dose

Children (6-16 years): Start treatment with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at 1-2 week intervals and administer twice daily; if the patient has difficulty tolerating the increase, reduce the increment or extend the interval between increases. The dose and extent 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 years-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 dose by 1-3mg/kg per day at 1-2 week intervals and administer in 2 divided doses daily until an adequate clinical effect is achieved. Dose titration should be determined according to 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 may increase thoughts or behaviors related to suicide while taking it, so patients and caregivers should carefully monitor for these symptoms. During the course of this medication, sudden skin rashes or severe skin reactions may occur, so any abnormal skin conditions should be reported to healthcare professionals immediately. During pregnancy, this medication may pose risks to the fetus; therefore, women of childbearing potential should take a pregnancy test before starting it, and effective contraception should be used during treatment. Patients with impaired kidney or liver function may experience delayed excretion of this medication, so the dosage should be adjusted according to the physician's instructions, and patients undergoing hemodialysis require dosage adjustments according to dialysis conditions. This medication may affect the central nervous system, leading to symptoms such as drowsiness, dizziness, and decreased concentration; therefore, it is advisable to avoid driving or operating machinery during the initial treatment period. Adequate fluid intake is important during treatment, as it helps reduce the risk of kidney stone formation. Abruptly stopping this medication may exacerbate seizures; therefore, any discontinuation or dosage reduction should be done gradually under a physician's guidance. Additionally, this medication may interact with other drugs, so it is essential to inform healthcare professionals of any other medications being taken, especially antiepileptics, contraceptives, diabetes medications, and lithium, as caution is required with combinations. This medication may cause various side effects, including weight loss, loss of appetite, depression, memory impairment, and speech disorders, so if any abnormal symptoms persist or worsen, consultation with healthcare professionals is necessary. Pregnant or breastfeeding women should consult with healthcare professionals regarding the use of this medication and should use it cautiously considering its potential impact on the fetus or newborn.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• perceptual disturbances
• rigidity
• ataxia

This medication should be stored in a tightly sealed container to prevent air exposure and should be kept in a dry place at or below 25 degrees Celsius. This helps maintain the effectiveness of the medication for a longer period.

Appearance

A white or almost white capsule filled with granules, with a transparent upper part and an opaque white lower part.

Package unit

28 capsules/bottle, 60 capsules/bottle