TOMAX 25mg (Topiramate)

Adult dose

It is preferable to start this drug at a low dose and increase it to the effective dose. Monitoring of blood concentrations is not necessary to optimize treatment with this drug. The recommended dose of this drug applies to all adults and children, including the elderly, provided they do not have renal disease. It may be administered with or without food. Tablets should be swallowed whole and not crushed. Epilepsy monotherapy, adults (17 years and older): Start with 25㎎ in the evening during the first week. Thereafter, increase the dose by 25 or 50㎎ per day at intervals of 1-2 weeks, administered in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and rate of titration are determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated up to 1,000㎎ per day as topiramate monotherapy. Epilepsy 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 during the first week; a lower starting dose is also possible. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks, administered in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, a smaller dose increase may be made or the interval between increases may be extended. The dose should be determined according to clinical effect. Migraine prophylaxis, adults: Start with 25mg of this drug in the evening during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, 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 titration 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 on hemodialysis: Because this drug is removed from plasma by hemodialysis, the dose on dialysis days should be increased by approximately 1/2. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer the additional dose in divided doses at 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 with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks, administered twice daily. If the patient has difficulty tolerating the increase, reduce the increment or extend the interval between increases. The dose and degree of titration should be determined according to clinical response. The recommended dose for pediatric monotherapy is 3-6mg/kg per day. Doses up to 500㎎ per day have been used in children diagnosed with partial seizures. Epilepsy adjunctive therapy, children (2-16 years): The recommended dose is approximately 5-9mg/kg per day, 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 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 up to 30mg/kg per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts and behaviors, so patients should consult their doctor immediately if any mood changes or unusual behavior occur during treatment. Also, there is a possibility of sudden death in epilepsy patients taking this medication; thus, regular health status checks are necessary. Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur, so if any abnormal skin symptoms appear, discontinue use immediately and inform medical personnel. Patients who are allergic to any component of this medication or have specific genetic issues like lactose intolerance should not take it. Women who are pregnant or may become pregnant must perform a pregnancy test before taking this medication and must use effective contraception during treatment. This medication may harm the fetus, and using it during pregnancy may increase the risk of growth restriction or malformations in the fetus, thus careful administration under a doctor's guidance is required. Patients with impaired kidney or liver function may have delayed excretion of this medication; therefore, dosage adjustment according to the doctor's instructions is necessary. This medication may cause side effects affecting the central nervous system such as drowsiness, dizziness, and visual disturbances; thus, caution should be exercised when driving or operating machinery after taking it. It is important to maintain adequate hydration during treatment to reduce the risk of kidney stone formation. Discontinuing this medication suddenly can worsen seizures, so when stopping the medication, it must be done gradually under a doctor's supervision. As this medication may interact with other drugs, inform your doctor or pharmacist about any other medications you are taking. Be aware of the various side effects that may occur during treatment, and consult medical personnel immediately if any unusual symptoms arise.

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

This medication should be stored in a tightly sealed container to prevent the ingress of air and moisture, and it is best stored in a cool, dry place below 25 degrees Celsius.

Appearance

Yellow, round, film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle