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. Monitoring plasma concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including elderly patients, provided they do not have renal disease. It may be administered with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually tapered and discontinued by approximately 1/3 every 2 weeks (see Precautions for Use, section “5. General Precautions”). When enzyme-inducing drugs are 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 with 25㎎ in the evening during the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the interval between increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated doses of up to 1,000㎎ daily as topiramate monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg daily, and the usual dose is 200-400mg daily in 2 divided doses. Depending on the patient, the dose may be increased up to the maximum recommended dose of 800mg daily. Initiate 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 intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating an increased dose, smaller dose increments may be used or the interval between 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 during the first week. Thereafter, increase the dose by 25mg/day at weekly intervals. If the patient has difficulty tolerating this titration, extend the interval between increases. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses of up to 200mg daily may be administered; the dose and rate of titration 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. - Hemodialysis patients: 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, the clearance of the dialysis device, and the patient's renal clearance, and administer the additional dose in divided portions at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment because clearance of this medicine may be reduced.

Child dose

1. Epilepsy 1) Monotherapy Children (6-16 years) Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at intervals of 1-2 weeks and administer twice daily. If the patient has difficulty tolerating the increase, use smaller increments or extend the interval between increases. The dose and extent of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg daily. In children diagnosed with partial seizures, doses of up to 500㎎ daily have been used. 2) Adjunctive therapy 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 daily) in the evening. Thereafter, increase the total daily dose by 1-3mg/kg at intervals of 1-2 weeks until an appropriate clinical effect is achieved, administered in 2 divided doses. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg daily have been administered and were generally well tolerated.

This medication is an antiepileptic drug, and it may increase the risk of suicidal thoughts or behaviors, so if there are mood changes or behavioral abnormalities during treatment, consult a healthcare professional immediately. There may be a risk of sudden death while taking this medication, so caution is especially required for patients with epilepsy. Serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur; if any abnormal skin symptoms appear, medication should be stopped immediately and healthcare professionals should be notified. Patients with an allergy to any components of this medication or those with certain genetic lactose intolerance should not take this drug, and women who are pregnant or planning to become pregnant should consult their doctor before taking this medication. Due to potential harm to the fetus when taking during pregnancy, women of childbearing age should use effective contraception, and careful administration is advised during pregnancy. Patients with impaired kidney or liver function need to adjust their drug concentration, so they should take this medication according to healthcare professionals' instructions. This medication can cause central nervous system side effects such as drowsiness, dizziness, and blurred vision, thus it is advisable to avoid driving or operating machinery after taking it. Adequate hydration is important, as there is a risk of kidney stones, and it is necessary to drink enough water. Mental health conditions such as mood changes, depression, or suicidal impulses should be observed carefully, and if symptoms worsen, healthcare professionals should be informed immediately. Sudden discontinuation of this medication may worsen seizures, so gradual reduction under the guidance of healthcare professionals is essential when stopping. This medication may interact with other drugs, so it is crucial to inform the doctor or pharmacist about any other medications being taken, especially when combined with contraceptives, lithium, antihypertensives, antihyperglycemics, etc. Pregnant or nursing women should carefully consider the effects on the fetus or newborn when taking this medication and consult a specialist if necessary.

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

This medication should be stored in a sealed container to prevent air or moisture from entering. Additionally, it should be kept in a cool place below 25 degrees Celsius and stored away from humidity.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle