Topiragen 100 mg (Topiramate)

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor plasma concentrations to optimize administration of this medicine. The recommended dose of this medicine applies to all adults and children, including elderly patients, provided they do not have renal disease. It may be administered with or without food. The tablet should be swallowed whole without crushing. Epilepsy monotherapy in adults (17 years and older): Start with 25 mg in the evening during the first week. Thereafter, increase the daily dose by 25 or 50 mg at intervals of 1-2 weeks and administer it in 2 divided doses per day. 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 dose for monotherapy in adults is 100–200 mg per day. The maximum recommended dose is 500 mg per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000 mg per day. Adjunctive therapy for epilepsy in adults (17 years and older): The minimum effective dose is 200 mg per day, and the usual dose is 200-400 mg per day in 2 divided doses. Depending on the patient, the dose may be increased up to the maximum recommended dose of 800 mg per day. Start treatment with 25-50 mg in the evening during the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50 mg at intervals of 1-2 weeks and administer it in 2 divided doses per day. If the patient has difficulty tolerating the increased dose, a smaller dose increase may be made or the interval between dose increases may be extended. The dose should be determined according to clinical effect. Migraine prophylaxis in adults: Start with 25 mg of this medicine in the evening during the first week. Thereafter, increase the dose by 25 mg/day at weekly intervals. If the patient has difficulty tolerating this titration, extend the interval between dose increases. The recommended dose is 100 mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50 mg per day. Doses up to 200 mg per day may be administered, and the dose and rate of titration should be determined according to clinical response. Patients with renal impairment - Moderate to severe (CLcr < 70 mL/min/1.73 m2) renal impairment: It is recommended that the starting and maintenance doses be reduced to approximately 1/2. Patients on hemodialysis: Since 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 residual renal clearance, and administer the increased dose in divided doses at the beginning and end of hemodialysis. Use with caution in patients with hepatic impairment because clearance of this medicine may be reduced.

Child dose

Epilepsy monotherapy in children (6-16 years): Start with 0.5-1 mg/kg in the evening during the first week. Thereafter, increase the daily dose by 0.5-1 mg/kg at intervals of 1-2 weeks and administer it twice daily. If the patient has difficulty tolerating the 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 dose for monotherapy in children is 3-6 mg/kg per day. Doses up to 500 mg per day have been used in children diagnosed with partial seizures. Adjunctive therapy for epilepsy in children (2-16 years): The recommended dose is approximately 5-9 mg/kg per day, administered in 2 divided doses. During the first week, administer 25 mg (or less, based on 1-3 mg/kg per day) in the evening. Thereafter, increase the daily dose by 1-3 mg/kg at intervals of 1-2 weeks until an appropriate clinical effect is achieved, administering it in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30 mg/kg per day have been administered and were generally well tolerated.

This drug may increase the risk of suicidal thoughts or behaviors; therefore, patients and caregivers should immediately inform healthcare professionals if such symptoms occur. While taking this medicine, sudden skin rashes or severe skin reactions may occur; thus, if abnormal skin conditions arise, patients should stop taking the medication immediately and consult with healthcare providers. During pregnancy, this drug may harm the fetus; hence, women who are pregnant or planning to become pregnant should discuss with their doctor and use effective birth control methods. Patients with impaired kidney or liver function may experience slower elimination or metabolism of this drug, necessitating dosage adjustments based on healthcare provider recommendations. This drug may cause central nervous system side effects such as drowsiness, dizziness, and blurred vision; therefore, it is safer to avoid driving or operating machinery during the initial period of use. Adequate hydration should be maintained to reduce the risk of kidney stone formation, particularly for patients with a history of kidney stones. This medication may interact with other antiepileptic drugs or multiple medications; hence, patients should inform their healthcare providers about any other medications they are taking and should not abruptly discontinue or change them. During treatment, changes in weight, mood changes, depressive symptoms, and other abnormalities should be regularly monitored; if unusual symptoms appear, patients should consult healthcare providers. When discontinuing the medication, dosage should be gradually reduced according to healthcare providers' instructions to minimize the risk of seizures. Serious side effects such as skin allergic reactions, blood disorders, and metabolic acidosis may rarely occur, thus it is crucial to inform healthcare providers immediately if any unusual symptoms appear.

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

This medication can be sensitive to air and moisture; therefore, it should be stored in a sealed container. It is recommended to keep it in a cool, dry place at a temperature below 25 degrees. Proper storage will help maintain the efficacy of the medication over time.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle