Topiramate
Product Images NDC 50436-9951

The text is an image containing a graph labeled "Figure 1: Kaplan-Meler Estimates of Cumulative Rates for Time to First Seizure". The graph compares the cumulative rates of time to first seizure for two groups: Topramate 50 molday (with 234 participants) and Topramate 400 mojany (with 236 participants). The x-axis is labeled "Time (Days)" and the y-axis is labeled "Cumulative Rates for 1st Seizure". There are no useful descriptions obtained from the text.*

This is a drug package for Topiramate containing 30 tablets, each with a dose of 100 mg. The National Drug Code (NDC) is 50436-9951-2, and the package lot number is 300X with an expiration date of OK. No further information is available.*

This is a titration schedule for monotherapy in adults and pediatric patients who are 10 years old or older. It is a table that shows the recommended dosage for the morning and evening doses week by week. The starting dose is 25mg and it is gradually increased until reaching 200mg by week 6.*

This is a summary table showing the interactions of different anti-epileptic drugs (AEDs) with topiramate. The table lists the effect of co-administered AEDs on topiramate concentration and vice versa. The drugs evaluated in the table include Phenytoin, Carbamazepine (and its active metabolite CBZ epoxidet e), Valproic Acid, Phenobarbital, Primidone, and Lamotrigine. The table suggests that co-administration of topiramate with Phenytoin may increase its concentration (up to 25%) while causing a decrease of up to 48% in Phenytoin levels. Carbamazepine use can reduce the concentration of topiramate, while its active metabolite has not been administered. Valproic acid can cause a decrease of up to 1% in its concentration and 14% in the concentration of topiramate. Phenobarbital and Primidone effects on topiramate have not been evaluated, while co-administration with Lamotrigine results in no significant difference up to 400 mg/day dose of topiramate. However, some patients may show a 25% increase in topiramate plasma concentration on twice-a-day dosing regimen of phenytoin.*

This is a table showing the summary of topiramate dosage during the stabilization periods of six double-blind, placebo-controlled, add-on trials in adults with partial onset seizures. The table includes the target topiramate dosages in milligrams per day (200, 400, or 1,000), the mean and median doses for each protocol, and the number of participants. Dose-response studies were not conducted for other indications or pediatric partial onset seizures. The placebo target dosages were also given in terms of the number of tablets per day for each protocol.*

This is a table showing the efficacy results of add-on epilepsy trials with Topiramate at different dosages. The trials are double-blind and placebo-controlled, and they were carried out in both adult and pediatric patients. The percentage reduction and the responders' rate for different types of seizures are reported. The table also includes the target Topiramate dosages (in mg/day) and some statistical comparisons with placebos.*

This is a table showing the target total daily maintenance dosing for patients aged between 2 to less than 10 years who are undergoing monotherapy treatment. It shows the minimum and maximum maintenance dose for patients of different weights, ranging from up to 11 kg to greater than 38 kg. The total daily dose in milligrams (mg) is administered twice a day in equal divisions.*

The text seems to be a table presenting the risk associated with different indications of antiepileptic drugs. It shows the number of events per 1000 patients for both placebo and drug patients, along with their relative risk, incidence risk difference, and additional drug events. The indications mentioned are epilepsy, psychiatric, and others.*

The table shows the incidence of treatment-emergent adverse reactions in monotherapy epilepsy where the rate was at least 2% in any Topiramate group, and the rate in the 400 mg/day Topiramate group was greater than the rate in the 50 mg/day Topiramate group for adults and pediatric patients in Study TOPAMAX-EPMN-106.The table lists various body systems and associated adverse reactions, along with the percentage incidence of the reactions in the Topiramate dosage groups.*

The text provides a table with adverse reactions to Topiramate tablets with dosage (mg/day). The table is divided by body system and displays the percentages of patients reporting a given adverse reaction in the topiramate 200-400mg/day group compared to the placebo group. It also provides information on the number of patients included in the study and the concomitant antiepileptic drugs used.*

The table displays the incidence of treatment-emergent adverse reactions in Study 119 where the incidence was 2% in the Topiramate group and greater than the rate in Placebo-treated patients. The table shows the percentage of patients reporting adverse reactions for different body systems and reactions. Patients in these add-on/adjunctive studies were receiving 1 to 2 concurrent antiepileptic drugs in addition to Topiramate or placebo.*

This is a table showing the incidence of dose-related adverse reactions from placebo-controlled, add-on trials in adults with partial onset seizures who took Topiramate at different dosages ranging from 200mg/day to 1000mg/day. The adverse reactions noted include fatigue, nervousness, difficulty with concentration/attention, confusion, depression, anorexia, language problems, anxiety, mood problems, and weight decrease. The percentage of individuals experiencing each adverse reaction at each dosage level is indicated in the table. The last sentence states that dose-response studies were not conducted for other adult medications or pediatric medications.*

The text describes the incidence of treatment-emergent adverse reactions in pediatric patients aged 2-16 years in placebo-controlled, add-on epilepsy trials. The table lists various adverse reactions with the percentage of patients reporting them in the placebo and topiramate groups. The reactions occurring in at least 1% of topiramate-treated patients and more frequently than placebo-treated patients are mentioned. Some of the adverse reactions include fatigue, injury, hypertension, nausea, somnolence, and urinary incontinence. The study notes that patients were receiving other antiepileptic drugs in addition to topiramate or placebo.*