Topiramate
Product Images NDC 50436-9951

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 50436-9951). 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 estimates of cumulative rates for time to first seizure comparing Topiramate 50 mg/day and 400 mg/day doses over approximately 500 days. The graph shows cumulative rates on the vertical axis and time in days on the horizontal axis with distinct curves for each dose group and a p-value of 0.0002 indicating statistical comparison.*

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Label Image (Lbl504369951)

Topiramate 100 mg tablets packaging label from Unit Dose Services. The label indicates a package containing 30 tablets with NDC 50436-9951-2. It states storage at controlled room temperature and includes placeholders for manufacturing and expiration details.*

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Struct (Struct)

Chemical structure of topiramate showing its molecular configuration with specific functional groups and stereochemistry.*

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Tbl1 (Table1)

A table titled 'Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older' listing morning and evening doses of a medication over six weeks. The doses increase weekly from 25 mg morning and 25 mg evening in week 1 to 200 mg morning and 200 mg evening by week 6.*

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Tbl (Table12)

Table summarizing interactions between antiepileptic drugs (AED) co-administered with Topiramate and their concentration changes. It includes AEDs like Phenytoin, Carbamazepine, Valproic acid, Phenobarbital, Primidone, and Lamotrigine, showing respective plasma concentration changes or notes such as 'Not Evaluated' and 'Less than 10% change'.*

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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,' showing protocol names, stabilization doses (number of patients), placebo counts, and target Topiramate dosages in mg/day ranging from 200 to 1,000. The table includes mean and median dose values for each trial protocol (YD, YE, Y1, Y2, Y3, I19) along with footnotes explaining dose-response study limitations and placebo dosage details.*

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Tbl14 (Table14)

A data table titled 'Efficacy Results in Double-Blind, Placebo-Controlled, Add-On Epilepsy Trials' presenting median percentage reduction and percentage of responders across various studies and target Topiramate dosages (mg/day). The table details results for adult and pediatric patient studies, including seizure types and syndromes, comparing placebo and multiple dosages ranging from 200 mg to over 1000 mg per day.*

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Tbl2 (Table2)

A data table titled 'Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to <10 Years' presenting weight ranges in kilograms with corresponding minimum and maximum total daily doses of Topiramate in milligrams per day. It includes 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' comparing event rates per 1000 patients between placebo and drug groups across indications including epilepsy, psychiatric, and other. It presents relative risk, incidence, and risk difference values for adverse events associated with antiepileptic drugs.*

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Tbl5 (Table5)

A data table presenting the incidence (%) of treatment-emergent adverse reactions during monotherapy with Topiramate in epilepsy patients. It compares pediatric (6 to <16 years) and adult (≥16 years) patients at daily doses of 50 mg and 400 mg. The table categorizes adverse reactions by body systems and provides percentage incidences for each group.*

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Tbl6 (Table6)

A detailed data table showing the percentage of patients experiencing various adverse reactions by body system for Topiramate tablets at dosages of 200 to 400 mg/day and 600 to 1,000 mg/day, compared to placebo. The table categorizes reactions such as nervous system, gastrointestinal, psychiatric, reproductive, respiratory, skin, urinary, vision disorders, and others, with patient counts in each dosage group indicated.*

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Tbl7 (Table7)

A data table showing the incidence of treatment-emergent adverse reactions in a clinical study comparing Topiramate tablets 200 mg/day with placebo. The table lists various body systems and specific adverse reactions, displaying the percentage of patients experiencing each reaction in both placebo and Topiramate groups.*

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Tbl8 (Table8)

A table showing the incidence percentages of dose-related adverse reactions from placebo-controlled, add-on trials in adults with partial onset seizures for Topiramate tablets at dosages of 200 mg/day, 600-1,000 mg/day, and placebo. It lists adverse reactions like fatigue, nervousness, concentration difficulty, confusion, depression, anorexia, language problems, anxiety, mood problems, and weight decrease along with their corresponding incidence percentages across groups.*

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Tbl9 (Table9)

A table presenting the incidence percentage of treatment-emergent adverse reactions in placebo-controlled, add-on epilepsy trials involving pediatric patients aged 2-16 years treated with Topiramate versus placebo. The table lists various body systems, associated adverse reactions, and compares occurrence percentages between placebo (N=101) and Topiramate (N=98) 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.