Topamed 100 mg (Topiramate)

Adult dose

It is preferable to start this drug at a low dose and increase it to the effective dose. There is no need to monitor blood levels to optimize the dose of this drug. The recommended dose of this drug is the same for all adults and children, including older adults, in the absence of renal disease. This drug may be taken with or without food. Swallow the tablet whole; do not crush it. Epilepsy monotherapy, adults (17 years of age and older): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at intervals of 1-2 weeks and administer in 2 divided doses per day. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and titration rate 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 doses of up to 1,000㎎ per day during topiramate monotherapy. Adjunctive therapy for epilepsy, adults (17 years of age 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 up to the maximum recommended dose of 800mg per day. Start 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 intervals of 1-2 weeks and administer in 2 divided doses per day. If the patient has difficulty tolerating the increased dose, the dose increase may be smaller or the interval between increases may be extended. The dose should be determined according to clinical effect. Prevention of migraine, adults: Start treatment with 25mg of this drug in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this increase, extend the interval between dose increases. The recommended dose is 100mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. The dose may be increased up to 200mg per day; the dose and titration rate should be determined according to clinical response. 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 receiving hemodialysis: Because this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and divide the dose between the start and end of hemodialysis. Use with caution in patients with hepatic impairment, as clearance of this drug may be reduced.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors in patients taking it, so patients and caregivers should immediately inform healthcare providers if these symptoms occur. During treatment with this medication, patients should be closely monitored for signs of depression, mood changes, and unusual behavior, and should respond promptly if any abnormal symptoms arise. Patients with epilepsy taking this medication may have a higher risk of sudden death compared to healthy individuals, thus regular health status checks are necessary. Serious skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur, so if symptoms such as rash, blisters, or warmth appear on the skin, use should be discontinued immediately and the healthcare provider should be consulted. Patients with hypersensitivity to this medication or with certain genetic metabolic disorders, such as lactose intolerance, should not take it. Pregnant women or women who may become pregnant must perform a pregnancy test before taking this medication and should use highly effective contraceptive methods during treatment. Taking this medication during pregnancy may risk fetal malformations or growth retardation; thus, it should be taken under careful medical supervision during pregnancy. For patients with reduced kidney or liver function, dosage adjustment and caution are necessary, as the elimination of the drug from the body may be delayed. This medication may affect the central nervous system, potentially causing drowsiness, dizziness, and blurred vision; therefore, during the initial phase of treatment, driving or operating machinery should be avoided. Adequate hydration is important during treatment, especially due to the risk of kidney stones; drinking plenty of water is advisable. Abruptly discontinuing this medication poses a risk of seizure occurrences; therefore, dose reduction should be done gradually under medical supervision when discontinuing use. This medication may interact with other drugs; thus, patients must inform healthcare providers of any other medications they are currently taking, particularly anticonvulsants, contraceptives, lithium, and diabetes medications. Pregnant or nursing women should consult a doctor before use, weighing the potential effects on the fetus or neonate.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The appropriate storage temperature is room temperature between 1°C and 30°C; it is advisable to avoid excessively hot or cold places.

Appearance

Light yellow round film-coated tablet

Package unit

30 tablets/bottle