Product Images Topiramate

This text provides a titration schedule for adult and pediatric patients who are 10 years or older for a Monotherapy treatment. It outlines the recommended dosage for five weeks, increasing the morning and evening dose every week until the fifth week when the dose reaches 150 mg. The text then shows a week 6 dosage of 200 mg for both morning and evening.*

This is a summary of the interactions between various antiepileptic drugs (AED) and topiramate. Table 12 provides information on the changes in the concentration of AED and topiramate when co-administered with other drugs. The table includes data on the concentration changes of AED such as phenytoin, carbamazepine, valproic acid, phenobarbital, primidone, and lamotrigine with topiramate. The changes in concentration range from a 25% increase to a 48% decrease. The text mentions an increase in plasma concentration of 25% in some patients, typically those on a twice a day dosing schedule of phenytoin.*

This is a table showing the summary of Topiramate doses administered during the stabilization periods of six double-blind, placebo-controlled, add-on trials in adults with partial onset seizures. Different protocols were used with varying target dosages and the mean and median doses administered were recorded. No dose-response studies were done for other indications or pediatric partial onset seizures. Placebo dosages were given as the number of tablets, with dosages ranging from four to ten tablets per day depending on the protocol.*

The text is a table showing efficacy results on add-on epilepsy trials with Topiramate Dosage in mg/day. The table reports median % reduction and % responders on partial onset seizures and primary generalized tonic-clonic seizures, among others. It also includes protocol efficacy results comparing placebo and different dosages of topiramate. The table specifies that for certain protocols, target dosages were assigned based on the subject's weight.*

Table 2 provides the targeted maintenance dosing range for monotherapy in patients aged 2 to under 10 years, based on weight. The maintenance doses range from 150-250 mg/day up to 250 mg/day, with the dose varying according to the patient's weight. The minimum and maximum dosing ranges are also specified in the table. The doses are to be administered in two equally divided doses.*

The text contains a table (Table 4) showing the risk of antiepileptic drugs for different indications based on a pooled analysis. The table includes the number of events per 1000 patients for both placebo and drug patients, as well as the relative risk, incidence risk difference, and additional events in patients taking the drug. The indications listed are epilepsy, psychiatric, and other, with varying risks associated with each.*

This text presents a table displaying the percentages of treatment-emergent adverse reactions in monotherapy epilepsy for pediatric (6 to <16 years) and adult (216 years) patients in Study TOPAMAX-EPMN-106. The adverse reactions are categorized by body system including General Disorders, Central & Peripheral Nervous System Disorders, Gastro-Intestinal System Disorders, Metabolic and Nutritional Disorders, Platelet, Bleeding & Clotting Disorders, Psychiatric Disorders, Red Blood Gl Disorders, Reproductive Disorders, Female, Resistance Mechanism Disorders, Respiratory System Disorders, Skin and Appendages Disorders, Special Senses Other Disorders, Urinary System Disorders, and Vascular (Extracardiac) Disorders. The percentages are calculated with the number of subjects in each group as the denominator.*

The given text lists the adverse reactions of Topiramate tablets and their dosage in mg/day. The table categorizes the reported reactions obtained from patients who were receiving 1 to 2 additional antiepileptic drugs. Adverse reactions reported by at least 1% of patients in the topiramate 200 to 400 mg/day group are listed in the table. The percentage of patients reporting the reaction is provided for each category. The adverse reactions are organized according to body systems/places. Common reported reactions are fatigue, dizziness, somnolence, nervousness, difficulty with memory, anorexia, depression, vision abnormality, and diplopia, among others.*

This table shows the incidence of treatment-induced side effects in a study where topiramate tablets were given to patients as an add-on/adjunctive treatment for epilepsy along with 1-2 other antiepileptic drugs. The adverse reactions that happened in at least 2% of patients in the topiramate 200 mg/day group with a frequency greater than the placebo group are listed in the table. The table displays the percentage of patients who reported each of these reactions. Adverse reactions are categorized based on the body system that they affect such as cardiovascular disorders, language problems, urinary system disorders, weight decrease, and psychiatric disorders, among others.*

This is a table (Table 8) that presents the incidence, in percentages, of dose-related adverse reactions from placebo-controlled, add-on trials in adults with partial onset seizures taking Topiramate at different dosages ranging from 0mg/day (placebo) to 1000mg/day. The study included parameters such as fatigue, nervousness, difficulty with concentration/attention, confusion, depression, anorexia, language problems, anxiety, mood problems, and weight decrease. No other dose-response studies were conducted for other adult medications or pediatric medications.*

The table shows the incidence of treatment-emergent adverse reactions observed in pediatric patients aged 2-16 years with epilepsy, in placebo-controlled add-on topiramate trials. The adverse reactions that occurred in at least 1% of topiramate-treated patients and more frequently than in the placebo group are listed. The reactions are categorized by body system, and the percentage of patients reporting each adverse reaction is shown. The add-on trials included patients receiving 1-2 concurrent antiepileptic drugs in addition to topiramate or placebo.*