Topiramate 100 mg Tablets

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring of blood concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including the elderly, provided they do not have renal disease. This medicine may be administered with or without food. Swallow the tablets whole; do not crush them. Epilepsy monotherapy: When discontinuing other concomitant antiepileptic medicines in order to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic medicines must be discontinued immediately for safety reasons, gradually taper them by approximately 1/3 at 2-week intervals. When enzyme-inducing medicines 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. Epilepsy monotherapy in adults (17 years and older): Initiate treatment with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1-2 week intervals, administered in 2 divided doses. If the patient has difficulty tolerating this dose escalation, extend the interval between increases. The dose and rate of increase 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. Epilepsy adjunctive therapy in 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, a maximum recommended dose of 800mg per day may be administered. Initiate 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 1-2 week intervals, administered 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. Migraine prevention in adults: Initiate treatment with 25mg of this medicine 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 dose escalation, extend the interval between increases. The recommended daily dose is 100mg, 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 increase should be determined according to clinical response. 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: Since 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, dialyzer clearance, and the patient's residual clearance, and administer it in divided doses at the beginning and end of hemodialysis. Use with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

Epilepsy monotherapy in children (6-16 years): Initiate treatment with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at 1-2 week intervals, administered twice daily. If the patient has difficulty tolerating the increase, use smaller increments or extend the interval between increases. The dose and degree 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. Epilepsy adjunctive therapy in children (2-16 years): The recommended daily dose is approximately 5-9mg/kg, administered in 2 divided doses. Administer 25mg (or less, based on 1-3mg/kg per day) in the evening during the first week. Thereafter, increase the dose by 1-3mg/kg per day at 1-2 week intervals until an appropriate clinical effect is achieved, administered 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 medication may increase the risk of suicidal thoughts or actions during treatment, so patients and caregivers should immediately inform healthcare professionals if such symptoms appear. Patients taking this medication may be at risk of sudden death and should exercise caution. Serious reactions may occur on the skin, so if symptoms such as rash or blisters appear, medication should be stopped immediately and healthcare providers consulted. Patients allergic to any ingredient of this drug or with certain genetic metabolic disorders should not take it. Women who are pregnant or planning to become pregnant must consult healthcare professionals before taking this medication and should use effective contraception while using it. Patients with kidney or liver function issues may need to adjust the dosage of this medication and should ensure adequate hydration to reduce the risk of kidney stones. This medication may affect the central nervous system, leading to symptoms like drowsiness, dizziness, and blurred vision, thus caution is needed when driving or operating machinery. Mental health status, including mood changes, depression, and anxiety, should be monitored periodically during therapy. Sudden withdrawal of this medication may lead to seizures; therefore, tapering off should be done gradually under the guidance of healthcare professionals. Interactions with other medications may occur, so all medications the patient is taking should be disclosed to healthcare providers, especially when combined with contraceptives, lithium, blood pressure medications, and diabetes medications. Taking this medication during pregnancy may cause fetal abnormalities or growth issues, hence pregnant women should carefully consider its use.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• perception abnormalities
• ataxia
• motor coordination disorder

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is also advisable to keep it in a cool, dry place below 25 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle