Topiramate 100 mg Tablet

Adult dosage

It is preferable 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 older adults, provided they do not have renal disease. This drug may be administered 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 use 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 drug may need to be reduced. Adults (17 years of age and older): Start with 25㎎ in the evening for the first week. Thereafter, increase by 25 or 50㎎ per day at 1-2-week intervals, administered in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, extend the titration interval. The dose and rate of titration 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 topiramate monotherapy at doses up to 1,000㎎ per day. 2) Adjunctive therapy Adults (17 years of age and older): The minimum effective dose is 200mg per day; the usual dose is 200-400mg per day in 2 divided doses. The maximum recommended dose of 800mg per day may be used depending on the patient. Start treatment with 25-50mg in the evening for the first week; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2-week intervals, administered in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, increase by a smaller amount or extend the titration interval. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this drug in the evening for the first week. Thereafter, increase the dose 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 up to 200mg per day may be administered; 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 starting and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Because this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Adjust the dose taking into consideration the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and divide the dose between the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment, as clearance of this drug may be reduced.

Children's dosage

Children (6-16 years of age): Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase by 0.5-1㎎/㎏ per day at 1-2-week intervals, administered twice daily. If the patient has difficulty tolerating the increase, reduce the increment or extend the titration interval. The dose and degree of titration 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-onset seizures. Children (2-16 years of age): The recommended dose is approximately 5-9mg/kg per day, administered in 2 divided doses. For 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, administered in 2 divided doses, until an appropriate clinical effect is achieved. Dose titration should be determined according to clinical effect. Doses 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, if any mood changes or symptoms of depression occur during treatment, it is essential to consult a physician immediately. There is a risk of sudden death in epilepsy patients, so regular health monitoring is necessary. Rarely, serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if severe rashes or blisters appear, it is crucial to stop using the medication and inform healthcare professionals. Patients with known allergies to this medication or certain genetic disorders such as lactose intolerance should not take this medication. Women of childbearing potential should confirm pregnancy before taking this medication, use effective contraceptive methods during treatment, and understand that taking this medication during pregnancy may harm the fetus. Patients with poor kidney or liver function may require dosage adjustments, and those undergoing dialysis should adjust the dosage according to dialysis conditions. Adequate fluid intake is essential due to the risk of kidney stones, and particular caution should be taken by patients with a history of kidney stones. While taking this medication, symptoms such as drowsiness, dizziness, or blurred vision may occur, necessitating caution while driving or operating machinery. This medication can cause various neuropsychiatric symptoms such as weight loss, decreased appetite, memory impairment, decreased concentration, insomnia, and depression, so patients should inform healthcare providers if any abnormal symptoms arise. It is advisable not to use this medication concurrently with alcohol or other central nervous system depressants. This medication may interact with other drugs, so it is important to notify your physician or pharmacist of any other medications being taken during treatment. Taking this medication during pregnancy may increase the risk of congenital malformations, low birth weight, and premature birth; therefore, women planning to conceive or currently pregnant should consult their healthcare professional. Abruptly discontinuing this medication may exacerbate seizures, so when discontinuing, it should be done gradually under a physician's direction. Routine blood tests and monitoring of kidney and liver function may be required during treatment. This medication may cause problems with temperature regulation due to decreased sweating, so it is particularly important to be cautious during hot weather. If symptoms such as altered consciousness, severe fatigue, or vomiting occur during treatment, immediate consultation with a physician is necessary.

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

This medication may be sensitive to air and moisture, so it is important to store it in a sealed container. Additionally, keep it in a cool, dry place at or below 25 degrees Celsius to maintain its efficacy.

Appearance

Light yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle