Topiramate 100mg Tablets

Adult dose

It is advisable to start this medication at a low dose and gradually increase it to the effective dose. There is no need to monitor blood levels to optimize the dosage of this medication. The recommended dosage of this medication applies equally to all adults and children, including the elderly, provided they do not have renal disease. This medication may be taken with or without food. Swallow the tablet whole; do not crush it. 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 need to be discontinued immediately for safety reasons, gradually reduce the dose of the other antiepileptic drugs by approximately 1/3 every 2 weeks until they are discontinued (see “5. General Precautions” under Precautions for Use). When enzyme-inducing drugs that affect drug metabolism are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations occurs, the dose of this medication may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the intervals between dose increases. The dose and titration rate should be determined according to the 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 with 25-50mg in the evening for 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 it in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller dose increments may be used or the intervals between dose increases may be extended. The dose should be determined according to the clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this medication in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend the intervals 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. Doses of up to 200mg per day may be administered; the dose and titration rate should be determined according to the 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 on hemodialysis: Because this medication is removed from plasma by hemodialysis, increase the dose of this medication by approximately 1/2 on dialysis days. Adjust the dose taking into account the duration of dialysis, the clearance of the dialysis equipment, 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 this medication with caution in patients with hepatic impairment, as its clearance 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 1-2-week intervals and administer twice daily. If the patient has difficulty tolerating the increase, reduce the dose increment or lengthen the interval between increases. The dose and extent of increase should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses up to 500㎎ per day have been used in children diagnosed with partial seizures. Children (2-16 years): 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 the daily dose by 1-3mg/kg at 1-2-week intervals and administer in 2 divided doses until an appropriate clinical response is achieved. Dose titration should be determined according to clinical response. Doses up to 30mg/kg per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors in patients taking it, so any symptoms should be reported to a healthcare professional immediately. During treatment, sudden skin rashes or severe skin reactions may occur; if there are abnormalities in the skin, stop use immediately and consult a healthcare professional. This medication may harm the fetus during pregnancy, so women who are pregnant or planning to become pregnant should consult a physician before taking it and must use effective contraceptive methods during treatment. Patients with poor kidney or liver function may require dose adjustments, so regular check-ups are necessary to monitor their condition. This medication can cause central nervous system side effects such as drowsiness, dizziness, and blurred vision, so it is advisable to avoid driving or operating hazardous machinery during the initial treatment period. Adequate hydration is important, especially due to the risk of kidney stones, so drink plenty of water and avoid dehydration. Weight changes, mood changes, or symptoms of depression may occur during treatment; it is necessary to consult healthcare professionals if these symptoms persist. This medication may interact with other drugs; notify your healthcare provider of any other medications you are taking, especially contraceptives, lithium, and antihypertensives, as caution is required when taking them together. Suddenly stopping this medication may worsen seizures; therefore, follow a physician's instructions to taper off gradually when discontinuing. Regular blood tests and kidney and liver function tests during treatment are important to check for abnormalities.

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

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it is best to store it in a cool, dry place below 25 degrees Celsius. Storing it this way helps maintain the medication's effectiveness for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle