TOMAX Tablet 100 mg (Topiramate)

Adult dose

It is advisable to start this drug at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize the dose of this drug. The recommended dose of this drug applies to all adults and children, including elderly patients, provided they do not have renal disease. This drug 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 in order to administer topiramate as monotherapy, consider the possible effects on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually tapered and discontinued by approximately one-third 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 drug may need to be reduced. Adults (17 years and older): Initiate treatment with 25 mg in the evening for the first week. Thereafter, increase the daily dose by 25 or 50 mg at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the titration intervals. The dose and titration rate should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg per day. The maximum recommended dose is 500 mg per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000 mg per day. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200 mg per day, and the usual dose is 200-400 mg per day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800 mg per day. Initiate treatment with 25-50 mg in the evening during the first week; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50 mg at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, the dose increment may be reduced or the titration interval extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Initiate treatment with 25 mg of this drug in the evening during the first week. Thereafter, increase the dose by 25 mg/day at weekly intervals. If the patient has difficulty tolerating this titration, extend the titration intervals. The recommended dose is 100 mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50 mg per day. Doses of up to 200 mg per day may be administered; the dose and titration rate 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 receiving hemodialysis: Because this drug is removed from plasma by hemodialysis, increase the dose of this drug 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 additional dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer this drug with caution to patients with hepatic impairment, as its clearance may be reduced.

Child dose

Children (6-16 years), monotherapy: Initiate treatment with 0.5-1 mg/kg in the evening during the first week. Thereafter, increase the daily dose by 0.5-1 mg/kg at intervals of 1-2 weeks and administer in 2 doses per day. If the patient has difficulty tolerating the dose increase, reduce the dose increments or extend the titration intervals. The dose and titration schedule should be determined according to clinical response. The recommended dose for pediatric monotherapy is 3-6 mg/kg per day. Doses of up to 500 mg per day have been used in children diagnosed with partial-onset seizures. Children (2-16 years), adjunctive therapy: The recommended dose is approximately 5-9 mg/kg per day, administered in 2 divided doses. During the first week, administer 25 mg (or less, based on 1-3 mg/kg per day) in the evening. Thereafter, increase the daily dose by 1-3 mg/kg at intervals of 1-2 weeks until an appropriate clinical effect is achieved, and administer in 2 divided doses. Dose titration should be determined according to clinical effect. Doses of up to 30 mg/kg per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behavior, and any mood or behavior changes during use should be discussed with a physician immediately. There is a risk of sudden death occurring in epilepsy patients, so any unusual symptoms during treatment should be promptly reported to healthcare professionals. Severe skin reactions may occur, so if a rash or red spots appear on the skin, it is important to stop taking the medication immediately and visit a hospital. If there is an allergy to any ingredient in this medication, it must not be taken, and patients with certain genetic lactose intolerance issues should also avoid use. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, as it may harm the fetus during pregnancy. Patients with kidney or liver function issues may require dose adjustments, so healthcare provider instructions should be followed. Adequate hydration during treatment is important, and drinking plenty of water is recommended to reduce the risk of kidney stones. This medication can cause central nervous system side effects such as drowsiness, dizziness, and decreased concentration, so care should be taken when driving or operating machinery. If sudden vision impairment or ocular pain occurs during use, it should be reported to medical staff immediately, as there may be issues related to increased intraocular pressure. Abruptly stopping this medication may worsen seizures, so any discontinuation should be done gradually according to a physician's instructions. There may be interactions with other medications, so if you are taking any, you must inform your doctor or pharmacist, particularly women on contraceptives, who should be aware that the contraceptive effect may diminish. Mental symptoms such as mood changes, depression, and anxiety may occur during treatment with this medication, and if these symptoms worsen, healthcare providers should be consulted immediately.

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

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is also recommended to be kept in a dry place at a cool temperature below 25 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle