Topiramate Tablets 100 Milligrams (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 dosage of this medicine. The recommended dosage of this medicine is the same for all adults and children, including older adults, who do not have renal disease. It may be taken regardless of meals. The 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, consider the potential effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, taper and discontinue them gradually 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 during the first week. Thereafter, increase the daily dose by 25 or 50㎎ at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and rate of titration should be determined according to clinical response. The recommended dosage for monotherapy in adults is 100～200mg/day. The maximum recommended dosage is 500㎎/day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000㎎/day. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg/day, and the usual dosage is 200-400mg/day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dosage of 800mg/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 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 interval between increases extended. The dosage 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 the daily dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, extend the interval between dose increases. The recommended dosage is 100mg/day, administered in 2 divided doses. Some patients may respond to a dose of 50mg/day. The dose may be increased to 200mg/day, and the dose and rate of titration 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 initial and maintenance doses be reduced to approximately 1/2. Patients on hemodialysis: Because this medicine is removed from plasma by hemodialysis, the dose on the day of dialysis should be increased by approximately 1/2. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis equipment, and the patient's renal clearance, and administer divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at intervals of 1-2 weeks and administer twice daily. If the patient has difficulty tolerating the dose increase, reduce the dose increment or extend the interval between increases. The dose and degree of titration should be determined according to clinical response. The recommended dosage for monotherapy in children is 3-6mg/kg/day. Doses of up to 500㎎/day have been used in children diagnosed with partial-onset seizures. Children (2-16 years): The recommended daily dosage is approximately 5-9mg/kg, administered in 2 divided doses. During the first week, administer 25mg (or less, based on 1-3mg/kg/day) in the evening. Thereafter, increase the daily dose by 1-3mg/kg at intervals of 1-2 weeks 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/day have been administered and were generally well tolerated.

This medication is an anti-epileptic drug and may increase the risk of suicidal thoughts or behavior, so patients and caregivers should promptly inform medical personnel of any psychological changes or symptoms of depression. During treatment with this medication, significant skin rashes or allergic reactions may occur suddenly; if any skin abnormalities appear, discontinue use immediately and consult a doctor. Women who are pregnant or planning to become pregnant must take a pregnancy test before using this medication and should use effective contraception during treatment. This medication may cause fetal malformations or growth delays, and thus should be used cautiously during pregnancy; it should not be administered for migraine prevention to pregnant women or women of childbearing age who are not using contraception. Patients with impaired renal or liver function may have delayed excretion of this medication and require dosage adjustment, and patients undergoing hemodialysis should adjust the dosage according to dialysis conditions. This drug may affect the central nervous system, causing symptoms such as drowsiness, dizziness, and blurred vision, so caution is needed when driving or operating machinery. Additionally, suddenly discontinuing this medication may worsen seizures; therefore, it must be gradually reduced according to a doctor's instructions. Ample hydration is essential during treatment with this medication, and attention should be paid to hydration due to the risk of kidney stones. This medication may interact with other drugs, so if any other medications are being taken, it is essential to inform a doctor or pharmacist. Particularly, caution is needed if valproate is taken concurrently, as it may lead to hyperammonemia. If taking contraceptives, this medication may reduce their effectiveness, so appropriate contraceptive methods should be maintained in consultation with a doctor. Due to this medication's administration, various side effects such as weight loss, lack of appetite, depression, and decreased concentration may occur; if any abnormal symptoms persist, consultation with medical personnel is advised. If abnormal behaviors or mood changes occur during treatment, please report them to medical personnel immediately, and seek professional help if suicidal thoughts or behaviors are suspected.

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

This medication is sensitive to air and humidity; therefore, it should be stored in a tightly sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius to safely maintain its effectiveness.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle