TOMAK Tablet (Topiramate)

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize the administration of this medicine. The recommended dose of this medicine is the same for all adults and children, including elderly patients, provided they do not have renal disease. It may be taken with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs to administer topiramate as monotherapy, consider the potential impact on seizure control. Except when 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 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 for the first week. Thereafter, increase the dose by 25 or 50㎎ daily at intervals of 1-2 weeks, administered in 2 divided doses. If the patient has difficulty tolerating this titration schedule, 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 daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy tolerated topiramate monotherapy at doses up to 1,000㎎ daily. 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. 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, administered in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the intervals 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 for 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 increases. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses up to 200mg daily may be administered; the dose and rate of increase should be determined according to clinical response. 3. Patients with renal impairment - In 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. - 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, dialyzer clearance, and the patient's renal clearance, and administer the dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use caution when administering this medicine to patients with hepatic impairment, as its clearance may be reduced.

Child dose

Pediatric patients (6-16 years) During the first week, begin treatment with 0.5-1㎎/㎏ in the evening. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks and administer it twice daily. If the patient has difficulty tolerating dose increases, reduce the size of each increase or extend the interval between increases. The dose and rate of increase should be determined according to clinical response. The recommended dose for monotherapy in pediatric patients is 3-6mg/kg per day. There is experience with doses of up to 500㎎ per day in pediatric patients diagnosed with partial seizures. Pediatric patients (2-16 years) The recommended daily dose is approximately 5-9mg/kg, divided into 2 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 intervals of 1-2 weeks until an appropriate clinical effect is achieved, dividing the dose into 2 daily administrations. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg per day have been used and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, if mood changes or unusual behaviors occur during treatment, it is essential to notify a healthcare professional immediately. Additionally, sudden death may occur in patients with epilepsy, so regular monitoring of their condition is necessary. This medication can cause serious skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis; thus, it should be discontinued immediately if any abnormal skin symptoms appear. Individuals allergic to the ingredients or with specific genetic disorders, as well as women of childbearing age, should not take this medication. Pregnant women or those planning to become pregnant should conduct a pregnancy test before taking this medication, ensure effective contraception, and be aware that it may harm the fetus. Patients with impaired kidney or liver function may require dosage adjustments, and there is a risk of kidney stones, so adequate hydration is necessary. This medication may cause central nervous system side effects, such as drowsiness, dizziness, and blurred vision; caution should be taken when driving or operating machinery. During treatment, weight changes, mood changes, depression, and memory impairment may occur, so if any unusual symptoms arise, consultations with healthcare providers are necessary. This medication can interact with other drugs, so it is crucial to inform healthcare providers about any other medications being taken; special caution should be taken when used with contraceptives, as contraceptive effectiveness may be reduced. When discontinuing this medication, it should not be stopped suddenly; tapering off should be done gradually, as abrupt cessation may increase the risk of seizures. Finally, regular blood tests and health checks are required when taking this medication; any adverse reactions should be reported to healthcare professionals immediately.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture and kept in a cool, dry place below 25 degrees Celsius. This will help maintain the medication's effectiveness and prevent degradation.

Appearance

Yellow round film-coated tablet

Package unit

30 T/bottle, 100 T/bottle