Topiramate Tablets

Effects and efficacy: Topiramate is suitable for monotherapy of patients with newly diagnosed epilepsy or epilepsy patients who have been treated with combined drugs and are now switched to monotherapy. It can also be used for the adjunctive treatment of partial epileptic seizures in adults and children aged 2 to 16 years. Usage and dosage: Topiramate capsules and topiramate tablets are both taken orally. Do not crush the tablets when taking them. This product can be taken whether fasting or not. The specific dosage should be followed according to the doctor’s advice. It is recommended to start treatment with a low dose for both adults and children, and then gradually increase the dose to adjust to the effective dose. When using this product for treatment, it is not necessary to monitor the plasma topiramate concentration to achieve the best therapeutic effect; when adding phenytoin sodium for treatment, only a very small number of cases need to adjust the dosage of phenytoin sodium to achieve the best clinical efficacy; during the adjunctive treatment of this product, the dose of this product may need to be adjusted when adding or stopping phenytoin and carbamazepine. The dose adjustment for adults (17 years and above) who are taking adjunctive treatment should start with 25~50mg per night and take it for 1 week. Subsequently, the dose is increased by 25-50 mg (to 100 mg)/day every 1 or 2 weeks, divided into 2 doses. The dose should be adjusted according to the clinical effect. Some patients can achieve efficacy at once a day. In clinical trials of add-on therapy, 200 mg was the lowest dose studied and was effective. Therefore, 200 mg is considered as the lowest effective dose, and the usual daily dose is 200-400 mg (taken in 2 doses). Some patients have received a dose of 1600 mg/day. The above recommended dose is suitable for all adults without underlying kidney disease, including elderly patients. For pediatric patients aged 2 to 16 years old as add-on therapy, the recommended total daily dose of this product is 5-9 mg/kg/day, taken in 2 doses. Dose adjustment should start with 25 mg every night (or less, dose range 1-3 mg/kg/day) for 1 week. Then increase the dose by 1-3 mg/kg/day (taken in 2 doses) every 1 or 2 weeks until the best clinical effect is achieved. The dose should be adjusted according to the clinical effect. A daily dose of 30 mg/kg/day has been studied and patients generally tolerate it well. Monotherapy When other antiepileptic drugs are discontinued and switched to topiramate monotherapy, the effect of discontinuation on epilepsy control should be considered. In general, the drug should be discontinued slowly, and it is recommended to reduce the dose by about 1/3 every 2 weeks, except for the immediate discontinuation of the combined antiepileptic drugs due to safety considerations. When enzyme-inducing drugs are discontinued, the blood concentration of topiramate will increase. If clinical symptoms occur, the dose of this product should be reduced. For adults (17 years and above), the dose adjustment should start with 25 mg every night for 1 week. Then, increase the dose by 25-50 mg per day every 1 or 2 weeks, divided into 2 doses. If the patient is intolerant to the dose adjustment scheme, the dose increase should be reduced, or the interval between dose adjustments should be extended. The dose and its adjustment speed should be adjusted according to clinical efficacy. For adults with topiramate monotherapy, the recommended initial target dose is 100 mg/day, with a maximum of 500 mg/day. Patients with refractory partial seizures can tolerate a dose of 1000 mg/day. The above recommended dose is applicable to all adults without underlying renal disease, including elderly patients. The dose for children aged 2 to 16 years should start at 0.5 to 1 mg/kg every night for 1 week. Increase the dose by 0.5 to 1 mg/kg/day (taken in 2 doses) every 1 or 2 weeks. If the patient does not tolerate the dose adjustment regimen, the dose increase should be reduced or the interval between dose adjustments should be extended. The dose and its adjustment rate should be adjusted according to clinical efficacy. The recommended initial target dose range for monotherapy with this product is 100 to 400 mg/day. For children with recently diagnosed partial seizures, the daily dose has reached 500 mg/day. Special populations Patients with impaired renal function Patients with moderate to severe renal impairment (CLCR < 70 ml/min) may need to reduce the dose of this product. The recommended starting dose and maintenance dose are half of the usual dose. Since this product can be cleared from plasma by hemodialysis, a supplemental dose of about half of the daily dose is given during hemodialysis. The supplementary dose should be divided into 2 times and given at the beginning and end of dialysis. The supplementary dose may vary depending on the dialysis machine used. Patients with impaired liver function Patients with impaired liver function should use topiramate with caution.
Drug contraindications:
Allergy to this product is prohibited. Use with caution during lactation. Use with caution during pregnancy. Use with caution in patients with impaired liver function
Related dosage forms:
Topiramate tablets, topiramate capsules