Topiramate Tablets (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 pediatric patients, including older adults, who do not have renal disease. This medicine 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 potential effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, gradually reduce and discontinue the other antiepileptic drugs by approximately 1/3 at 2-week intervals (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): During the first week, begin treatment with 25㎎ in the evening. Thereafter, increase the dose by 25 or 50㎎ per day at intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating this titration, 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 per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000㎎ per day. 2) 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. Begin treatment during the first week with 25-50mg in the evening; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller 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: During the first week, begin treatment with 25mg of this medicine in the evening. 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 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 undergoing hemodialysis: Since this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Adjust 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 with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

Pediatric patients (6-16 years), monotherapy: 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), adjunctive therapy: 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, any mood changes or unusual behaviors during treatment should be immediately discussed with a physician. Patients with epilepsy may have a risk of sudden death, so regular monitoring of the patient's condition during treatment is important. Serious skin reactions may occur during treatment with this medication; therefore, if rash or other skin abnormalities develop, use should be discontinued immediately and healthcare personnel should be notified. Patients with a known allergy to this medication or with specific genetic lactose intolerance should not take this medication. Women who are pregnant or planning to become pregnant should conduct a pregnancy test before starting this medication and should use effective contraception, as taking this medication during pregnancy may harm the fetus. Patients with impaired kidney or liver function may need to adjust the dosage of this medication, and the time the drug remains in the body may change depending on kidney function. Adequate hydration is necessary while taking this medication, and it is advised to drink plenty of water to reduce the risk of kidney stones. This medication may cause central nervous system side effects such as drowsiness, dizziness, and blurred vision, so caution is advised when driving or operating machinery, particularly at the beginning of treatment. Weight changes may occur during treatment; therefore, dietary regulation and nutrition status should be managed well. This medication may interact with other drugs, so it is essential to inform healthcare personnel about any other medications being taken, particularly contraceptives, lithium, and other antiepileptics. Mental symptoms such as depression, anxiety, or aggression may appear during treatment; if such symptoms develop, immediate consultation with healthcare personnel is required. Abrupt discontinuation of this medication may worsen seizures, so it should be gradually reduced under the supervision of a physician when stopping treatment. Pregnant or breastfeeding women should consult a physician before taking this medication, as it may affect the fetus or baby.

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

This medication should be stored in a sealed container to protect from air and moisture. It is best stored in a cool, dry place at a temperature below 25 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle