Boryeong Topiramate 25 mg Tablet

Adult dosage

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including elderly patients, 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 them 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): Start with 25㎎ in the evening for the first week. Thereafter, increase the daily dose by 25 or 50㎎ at 1-2 week intervals and administer in 2 divided doses. If the patient has difficulty tolerating this titration, extend the interval between dose increases. 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 up to 1,000㎎ per day as topiramate monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg per day; 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 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 and administer 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: Start with 25mg of this medicine in the evening for the first week. Thereafter, increase the daily dose by 25mg at 1-week intervals. If the patient has difficulty tolerating the increase, extend the interval 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. The dose may be increased to 200mg per day; the dose and rate of increase should be determined according to clinical response. 3. Patients with renal impairment - In 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. - Hemodialysis patients: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Increase 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 amounts at the beginning 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.

Children's dosage

Children (6-16 years), monotherapy: Start with 0.5-1㎎/㎏ in the evening for 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 increment or extend the interval between increases. The dose and extent of titration 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 seizures, doses up to 500㎎ per day have been used. Children (2-16 years), adjunctive therapy: The recommended dose is approximately 5-9mg/kg per day, 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 until an appropriate clinical effect is achieved, and administer in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg per day have been administered and were generally well tolerated.

This medicine may increase the risk of suicidal thoughts or behaviors, so if mood changes or symptoms of depression occur during treatment, you should inform your healthcare provider immediately. Patients with epilepsy taking this medication may be at risk for sudden death, so they should be closely monitored for changes in symptoms. Serious skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur, and if abnormal skin symptoms appear, discontinue use immediately and consult with your healthcare provider. Patients allergic to any components of this medication or those with certain genetic lactose intolerance disorders should not take it, and pregnant women or those planning to become pregnant should consult with a physician before taking this medication. Women of childbearing age should use effective contraception while taking this drug, as there is a risk of fetal harm and growth restriction during pregnancy, so it should be administered with caution. Patients with reduced kidney function may have delayed elimination of this medication, requiring dose adjustment, and patients undergoing dialysis should adjust the dose according to dialysis conditions. There is a risk of kidney stones, therefore adequate hydration is necessary, and patients with a history of kidney stones should be particularly cautious. This medication affects the central nervous system and may cause drowsiness, dizziness, and decreased concentration, so caution should be exercised when driving or operating machinery. During treatment, psychiatric side effects such as depression, anxiety, aggression, and memory impairment may appear, and if such symptoms occur, inform your healthcare provider. This medication can interact with other drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist, especially when taking it with antiepileptic drugs, contraceptives, lithium, antihypertensives, etc. Abruptly discontinuing this medication may worsen seizures, so when discontinuing, it should be tapered off gradually following medical advice. Taking this medication during pregnancy may increase the risk of congenital malformations and neurodevelopmental disorders in the fetus, so women who are pregnant or planning to become pregnant should consult with their physician. Various adverse reactions like weight loss, loss of appetite, fatigue, visual disturbances, skin rashes may occur, so if any of these symptoms persist or worsen, consult with your healthcare provider.

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

This medication should be stored in a tightly sealed container as it may be sensitive to air and moisture. It is best to keep it in a cool, dry place below 25 degrees Celsius. Proper storage helps maintain the medication's efficacy over time.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle