Torafen 100 mg (Topiramate)

Adult dose

This medicine should preferably be started at a low dose and increased to the effective dose. There is no need to monitor blood levels to optimize dosing of this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, without renal disease. It may be taken with or without food. Tablets should be swallowed whole and not crushed. 1. Epilepsy 1) Monotherapy Adults (17 years and older): Start 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. If the patient has difficulty tolerating this dose escalation schedule, extend the interval between dose increases. The dose and rate of dose escalation 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. 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 for the first week; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller dose increments may be used or the interval between dose increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start 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 this dose escalation, 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. Doses of up to 200mg per day may be administered; the dose and rate of dose escalation 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 starting 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 administered in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment This medicine should be administered with caution to patients with hepatic impairment, as its clearance may be reduced.

Child dose

Children (6-16 years) Monotherapy: Start 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 dose increase, reduce the dose increment or extend the interval between dose increases. The dose and extent of dose escalation 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) Adjunctive therapy: The recommended dose is approximately 5-9mg/kg per day, 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, administering in 2 divided doses. 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 may increase the risk of suicidal thoughts or behaviors, so if any symptoms of depression or mood changes occur during treatment, patients should consult their doctor immediately. Patients with epilepsy taking this medication are at risk of sudden death, so regular health check-ups and adherence to the doctor’s instructions are essential. Serious skin reactions may occur rarely; if a rash or blisters appear, patients should stop taking the medication immediately and seek medical attention. Patients with allergies to any of the ingredients in this drug should not use it, and those with lactose intolerance should also avoid it. Women who are pregnant or planning to become pregnant should consult their doctor before taking this medication, as it may harm the fetus during pregnancy. Patients with kidney or liver problems may need dosage adjustments when taking this medication, so adhere to medical instructions. This medication can cause central nervous system side effects like drowsiness, dizziness, and blurred vision, so it is advisable to avoid driving or operating machinery during the initial phase of treatment. Adequate hydration is necessary during treatment, and patients should consistently drink water to reduce the risk of kidney stones. Suddenly stopping this medication can worsen seizures; therefore, the dosage should be reduced gradually under the doctor’s guidance. There may be interactions with other drugs, so patients should inform healthcare providers about any other medications they are taking, especially not to take this medication with alcohol or central nervous system depressants. Women taking contraceptive pills should know that this medication may reduce contraceptive effectiveness, so additional contraceptive methods are recommended. This medication may cause various side effects such as weight loss, decreased appetite, mood changes, and memory impairment, so any abnormal symptoms should be discussed with healthcare providers. Taking this medication during pregnancy may increase the risk of congenital malformations or growth restrictions in the fetus, so careful consideration is needed regarding usage during pregnancy. Regular check-ups for blood tests or vision tests may be required, so it’s important to visit the hospital regularly to monitor your condition.

• suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• paresthesia
• hyperesthesia
• ataxia

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. The recommended storage temperature is at a cool place below 25 degrees, in a dry environment with low humidity.

Appearance

Yellow round film-coated tablets

Package unit

100 tablets/bottle, 30 tablets/bottle