Topiramate Tablets 100 mg (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor blood levels to optimize administration of this medicine. The recommended dose of this medicine is the same for all adults and children, including the elderly, in the absence of renal disease. It may be administered regardless of meals. Swallow the tablet whole; do not crush it. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, consideration should be given to the possible effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, gradually reduce and discontinue the other antiepileptic drugs by approximately 1/3 every 2 weeks (see “5. General precautions” under Precautions for use). When an enzyme-inducing drug is discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentration occurs, the dose of this medicine may need to be reduced. Adults (17 years and older): Start treatment with 25㎎ in the evening during the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1-2 week intervals, administered in 2 divided doses daily. If the patient has difficulty tolerating this rate of increase, extend 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 doses of up to 1,000㎎ per day of 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 up to the maximum recommended dose of 800mg per day. Start treatment with 25-50mg in the evening during the first week; treatment may also be started at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2 week intervals, administered in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the intervals between dose increases may be extended. The dose should be determined according to clinical response. 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, 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 to 200mg per day; the dose and rate of increase 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 to reduce the starting and maintenance doses 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 consideration the duration of dialysis, the clearance of the dialysis apparatus, and the patient's renal clearance, and administer the dose in divided portions at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as 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, administered twice daily. If the patient has difficulty tolerating the increase, use smaller increments or extend the intervals 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. 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 dose by 1-3mg/kg per day at 1-2 week intervals until an appropriate clinical effect is achieved, administered in 2 divided doses daily. Dose titration should be determined according to clinical response. 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 mood changes or symptoms of depression occur during treatment, it is important to notify your healthcare provider immediately. Furthermore, patients with epilepsy taking this medication may have an increased risk of sudden death, so regular assessments should be performed as per the physician's directives. Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur rarely; if abnormal skin symptoms appear, the drug should be discontinued immediately, and medical attention should be sought. Patients with hypersensitivity to the components of this drug or lactose intolerance should not take it, and women who are pregnant or planning to become pregnant should take particular caution. If a pregnant woman takes this medication, it could harm the fetus, so one should consult their physician before and after pregnancy and use effective contraception methods. Patients with renal or hepatic impairment may need dosage adjustments due to delayed elimination of this medication, and adequate hydration is important to reduce the risk of kidney stones. This medication affects the central nervous system and may cause symptoms such as drowsiness, dizziness, and blurred vision, so it is advisable to avoid driving or operating machinery during the initial stages of treatment. The medication should be discontinued gradually; sudden withdrawal may increase the risk of seizures. Moreover, this medication may interact with other drugs, so any concurrent medications must be reported to the healthcare provider. Adverse reactions reported in clinical trials and post-marketing surveys include fatigue, loss of appetite, weight loss, depression, memory impairment, nausea, diarrhea, etc., and if adverse symptoms persist, medical consultation is advised. Finally, difficulty in regulating body temperature may arise while taking this medication, so caution is particularly advised in hot environments, and adequate hydration should be maintained.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, preferably kept in a cool, dry place at a temperature below 25 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle