Topamax Sprinkle Capsules 50 Milligrams (Topiramate)

Adult dose

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. 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. 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. 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. Administer with caution to patients with hepatic impairment because clearance of this medicine may be reduced.

Child dose

Monotherapy in 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. Adjunctive therapy in 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 the prevention of epilepsy and migraines. There may be an increased risk of suicidal thoughts or behaviors during treatment, so patients and caregivers should inform medical personnel immediately if mood changes or suicidal impulses occur. Abruptly stopping this medication can lead to more frequent seizures, so it should be tapered off gradually according to a doctor's instructions. Drowsiness, dizziness, and visual disturbances may occur during treatment, so caution should be exercised when driving or operating machinery. This medication can cause serious skin reactions, so treatment should be stopped immediately if skin rashes, blisters, or mucosal damage occur. Patients with impaired kidney function may require dosage adjustments due to possible changes in the drug concentration, and patients on hemodialysis should have their doses adjusted based on dialysis conditions. Taking this medication during pregnancy may cause harm to the fetus, and there is a risk of low birth weight or congenital disabilities, so women of childbearing age should use effective contraceptive methods along with pregnancy tests. This medication can increase the risk of dehydration or kidney stones, so adequate hydration is important. Additionally, this medication may interact with other drugs, so if patients are taking other medications, they must inform their doctor or pharmacist. Many side effects such as fatigue, dizziness, memory impairment, decreased appetite, and depression may occur, so patients should consult healthcare professionals if they experience abnormal symptoms.

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

This medication should be stored in a tightly sealed container that is well ventilated, in a dry place at a temperature below 25 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance

Capsule filled with white or nearly white granules; upper part is transparent and lower part is opaque white.

Package unit

28 capsules/bottle, 60 capsules/bottle