Topiramate
Product Images NDC 53217-274

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 53217-274). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Image (Topiramate Usp 1)

A table titled 'Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older' showing the morning and evening doses of Topiramate over six weeks, with doses increasing from 25 mg in Week 1 to 200 mg by Week 6.*

FDA Label Image

Image (Topiramate Usp 10)

A Kaplan-Meier survival curve graph showing cumulative rates for time to first seizure comparing two doses of Topiramate (50 mg/day and 400 mg/day). The x-axis represents time in days up to 500, and the y-axis shows cumulative rates up to 0.50. The graph includes two lines with different patterns representing the two dosages with sample sizes noted.*

FDA Label Image

Image (Topiramate Usp 11)

Table titled 'Efficacy Results in Double-Blind, Placebo-Controlled, Add-On Epilepsy Trials' showing protocol efficacy results of Topiramate dosage levels (200 to 1000 mg/day and ~6 mg/kg/day) on various seizure studies in adults and pediatric patients. It includes sample size (N), median percentage seizure reduction, and percentage of responders across different protocols and seizure types.*

FDA Label Image

Image Description (Topiramate Usp 12)

Topiramate USP 100 mg tablet blister card from Aidarex Pharmaceuticals LLC. The label indicates 60 film-coated, light yellow, round tablets. The product is generic for Topamax and includes NDC 53217-0274-60. Manufacturer is Ascent Pharmaceuticals Inc., Central Islip, NY. Additional labeling shows prescription information and patient instructions in English and Spanish.*

FDA Label Image

Image (Topiramate Usp 2)

A table showing monotherapy target total daily maintenance dosing of Topiramate for patients aged 2 to under 10 years. It lists weight ranges in kilograms and corresponding minimum and maximum total daily dose in milligrams, with doses administered in two equally divided amounts.*

FDA Label Image

Image (Topiramate Usp 3)

Data table titled 'Risk by Indication for Antiepileptic Drugs in Pooled Analysis' showing comparison of event incidence between placebo and drug patients across indications (Epilepsy, Psychiatric, Other). It includes columns for events per 1000 patients, relative risk of events, and risk difference for additional drug patients with events.*

FDA Label Image

Image (Topiramate Usp 4)

A data table showing the incidence percentages of treatment-emergent adverse reactions in monotherapy epilepsy patients using Topiramate tablets. The table compares 50 mg/day and 400 mg/day doses across pediatric (6 to <16 years) and adult (≥16 years) age groups, detailing various body systems and specific adverse reactions reported in the TOPAMAX-EPMN-106 study.*

FDA Label Image

Image (Topiramate Usp 5)

Adverse reactions data table for Topiramate tablets showing percentages of patients experiencing various side effects by body system across placebo, 200 to 400 mg/day, and 600 to 1,000 mg/day dosage groups. Categories include general disorders, nervous system, gastrointestinal, psychiatric, reproductive, respiratory, skin, urinary, vision, and others with graded incidence rates.*

FDA Label Image

Image (Topiramate Usp 6)

Data table titled 'Incidence of Treatment-Emergent Adverse Reactions in Study 119a,b' comparing the percentage of various adverse reactions in patients taking placebo (N=92) versus Topiramate Tablets Dosage 200 mg/day (N=171). Reactions are categorized by body system and psychiatric, respiratory, urinary, and vision disorders, showing a higher incidence in the Topiramate group for all listed reactions.*

FDA Label Image

Image (Topiramate Usp 7)

A data table showing the incidence percentages of dose-related adverse reactions from placebo-controlled, add-on trials of Topiramate tablets in adults with partial onset seizures. It compares adverse reactions including fatigue, nervousness, confusion, depression, and others across placebo and three dosage groups: 200 mg/day, 600-1,000 mg/day.*

FDA Label Image

Image (Topiramate Usp 8)

A data table showing the incidence percentage of treatment-emergent adverse reactions in placebo-controlled, add-on epilepsy trials for pediatric patients aged 2 to 16 years. It compares adverse reaction rates between placebo (N=101) and topiramate (N=98) treated groups, categorized by body system and disorder type, listing specific reactions and their occurrence percentages.*

FDA Label Image

Image (Topiramate Usp 9)

Chemical structure diagram of Topiramate, showing the molecular arrangement and functional groups of the active ingredient.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.