Topiramate
Product Images NDC 50436-9950

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 50436-9950). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

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Fig1 (Fig1)

Kaplan-Meier plot showing cumulative rates for time to first seizure for Topiramate at doses of 50 mg/day and 400 mg/day. The x-axis represents time in days up to 500 days, and the y-axis shows cumulative rates. The graph compares seizure occurrence between two dosage groups with statistical significance indicated (p = 0.0002).*

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Label Image (Lbl504369950)

Topiramate 50 mg tablet label from Unit Dose Services featuring the product name, strength, dosage form (60 tablets), NDC 50436-9950-2, and storage instructions. The label includes placeholders for manufacturing and expiration dates, lot numbers, and identifies the manufacturer as Unit Dose Services, LLC, Miami, FL.*

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Struct (Struct)

Chemical structure diagram of Topiramate showing its molecular rings and functional groups, including methyl, sulfate, and amine components, consistent with its verified identity.*

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Tbl1 (Table1)

A data table titled "Table 1: Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older" listing morning and evening doses of Topiramate in milligrams for Weeks 1 through 6, starting at 25 mg twice daily and increasing to 200 mg twice daily by Week 6.*

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Tbl (Table12)

Table summarizing antiepileptic drug (AED) interactions with Topiramate, showing changes in plasma concentrations of AEDs and Topiramate when co-administered. The table lists AEDs like Phenytoin, Carbamazepine, Valproic acid, Lamotrigine, and others, detailing percentage decreases or no change in concentrations, with abbreviations explained in footnotes.*

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Tbl13 (Table13)

A data table titled "Topiramate Dose Summary During the Stabilization Periods of Each of Six Double-Blind, Placebo-Controlled, Add-On Trials in Adults with Partial Onset Seizures." The table lists protocols (YD, YE, Y1, Y2, Y3, 119) with the number of subjects (N), placebo counts, mean doses, median doses, and target Topiramate dosages ranging from 200 to 1,000 mg/day. Notes below clarify dosing details and study conditions.*

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Tbl14 (Table14)

A data table titled 'Efficacy Results in Double-Blind, Placebo-Controlled, Add-On Epilepsy Trials' summarizing the median percentage reduction and percentage of responders for Topiramate at dosages ranging from placebo to 1,000 mg/day in adult and pediatric seizure studies, including specific trials for partial onset seizures, primary generalized tonic-clonic seizures, and Lennox-Gastaut syndrome. The table includes multiple protocols and highlights statistical comparisons with placebo.*

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Tbl2 (Table2)

A table titled 'Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to <10 Years' showing weight ranges in kilograms alongside corresponding minimum and maximum total daily maintenance doses in milligrams per day, with a note that doses are administered in two equally divided doses.*

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Tbl4 (Table4)

A data table titled 'Risk by Indication for Antiepileptic Drugs in Pooled Analysis' presenting risk statistics for epilepsy, psychiatric, and other indications. It compares placebo and drug patients' event rates per 1000 patients, relative risk ratios, and risk differences for additional drug patients with events.*

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Tbl5 (Table5)

Data table showing the incidence percentages of treatment-emergent adverse reactions in pediatric and adult patients treated with Topiramate tablets at daily doses of 50 mg and 400 mg. The table categorizes adverse reactions by body system, comparing rates for various side effects in epilepsy monotherapy for patients aged 6 to under 16 years and adults 16 years and older.*

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Tbl6 (Table6)

Data table displaying adverse reactions reported during Topiramate tablets clinical trials, categorized by body system and dosage group (placebo, 200-400 mg/day, and 600-1,000 mg/day). It lists the percentage of patients experiencing various side effects such as general disorders, nervous system, gastrointestinal, psychiatric, reproductive, respiratory, skin, urinary, vision, and blood disorders.*

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Tbl7 (Table7)

Data table presenting the incidence of treatment-emergent adverse reactions occurring in 119a,b patients treated with Topiramate 200 mg/day compared to placebo. The table categorizes adverse reactions by body system, listing specific disorders and the percentage of patients experiencing each reaction in both Topiramate and placebo groups.*

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Tbl8 (Table8)

A data table titled 'Incidence (%) of Dose-Related Adverse Reactions From Placebo-Controlled, Add-On Trials in Adults with Partial Onset Seizures.' It compares the percentage incidence of various adverse reactions such as fatigue, nervousness, confusion, and anxiety among placebo and Topiramate tablet dosage groups (200 mg/day, 600-1000 mg/day).*

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Tbl9 (Table9)

A data table listing the incidence percentage of treatment-emergent adverse reactions in placebo-controlled pediatric epilepsy trials for Topiramate compared to placebo. It categorizes adverse reactions by body system and reaction type, showing comparative percentages for the Topiramate and placebo groups.*

* 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.