Topiramate 50 mg Tablets (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize the dose of this medicine. The recommended dose of this medicine applies to all adults and children, including the elderly, in the absence of renal disease. This medicine may be taken with or without food. Tablets should be swallowed whole and not crushed. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, the potential impact on seizure control should be considered. Unless another antiepileptic drug must be discontinued immediately for safety reasons, it should be gradually reduced and discontinued by approximately 1/3 every 2 weeks (see section “5. General precautions” under Precautions for use). When a drug that induces drug-metabolizing enzymes is discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations 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 by 25 or 50㎎ per day at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, extend the titration interval. The dose and rate of increase should be 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 of topiramate monotherapy. 2) Adjunctive therapy The minimum effective dose in adults (17 years and older) 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; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, the dose may be increased by a smaller amount or the titration interval 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 by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, extend the titration interval. The recommended dose is 100mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. Doses of up to 200mg per day may be administered; 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 that the starting and maintenance doses be reduced to approximately 1/2. - Patients receiving hemodialysis: Because this medicine is removed from plasma by hemodialysis, the dose of this medicine should be increased by approximately 1/2 on dialysis days. Increase the dose taking into consideration the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer the increased dose in divided doses at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

Children (6-16 years), epilepsy monotherapy: Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase by 0.5-1㎎/㎏ per day at 1-2 week intervals and administer twice daily. If the patient has difficulty tolerating the increase, reduce the increment or extend the titration interval. 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. In children diagnosed with partial-onset seizures, doses of up to 500㎎ per day have been used. Children (2-16 years), epilepsy adjunctive therapy: 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 by 1-3mg/kg per day at 1-2 week intervals and administer in 2 divided doses until an appropriate clinical effect is achieved. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication is used as an anticonvulsant for epilepsy and migraine prevention; however, there is an increased risk of suicidal thoughts or behaviors while taking it, so caution is required. If symptoms of depression, mood changes, or abnormal behavior occur during use, notify a healthcare provider immediately. Furthermore, this medication can rarely cause serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if any rash or blisters develop, stop taking the medication immediately and seek medical attention. It may harm the fetus during pregnancy, so women who could become pregnant should take a pregnancy test before use and employ effective contraception during treatment. Patients with impaired kidney or liver function may experience delayed elimination of this medication, requiring dose adjustment and ensuring adequate hydration to prevent kidney stones. This drug may cause side effects such as drowsiness, dizziness, or impaired concentration, so caution is advised when driving or operating machinery. It is safer to gradually taper off the medication to reduce the risk of seizures when discontinuing. Additionally, this medication can interact with other drugs; inform your healthcare provider if you are taking other medications, especially contraceptives, as their efficacy may decrease. Lastly, various adverse reactions such as weight changes, appetite changes, mood changes may occur during treatment, so it is important to monitor your condition regularly.

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

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Keep it in a cool place below 25 degrees Celsius, preferably in a dry environment with low humidity.

Appearance

Pale yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle