Topiramate
Product Images NDC 50436-9949

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 50436-9949). 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.

FDA Label Image

Fig1 (Fig1)

Kaplan-Meier plot showing cumulative rates for time to first seizure in days for two doses of Topiramate, 50 mg/day and 400 mg/day, with separate lines representing each dosage and cumulative seizure rates on the y-axis.*

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Label Image (Lbl504369949)

Topiramate 25 mg tablet label with 30 tablets per package. The label includes the product NDC 50436-9949, states storage at controlled room temperature, and shows manufacturing details including the manufacturer as Camber Pharm and packaging by Unit Dose Services, LLC, Miami, FL. It is marked with an Rx symbol.*

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Struct (Struct)

Chemical structure diagram of the active ingredient Topiramate, showing its molecular composition including carbon, oxygen, sulfur, nitrogen, and hydrogen atoms arranged in its characteristic rings and functional groups.*

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Tbl1 (Table1)

A table titled 'Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older' showing weekly morning and evening dosages of Topiramate. Dosages increase weekly from 25 mg both morning and evening in Week 1 to 200 mg both morning and evening by Week 6.*

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Tbl (Table12)

Table summarizing antiepileptic drug (AED) interactions with Topiramate, showing changes in AED and Topiramate plasma concentrations when co-administered, including drugs such as Phenytoin, Carbamazepine, Lamotrigine, and Valproic acid, along with notes on plasma concentration changes and abbreviations used.*

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Tbl13 (Table13)

A 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.' It summarizes stabilization dose data including sample size (N), mean dose, and median dose across various protocols (YD, YE, Y1, Y2, Y3, 119) for different target Topiramate dosages ranging from placebo to 1000 mg/day. It includes footnotes clarifying dose-response studies 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 to various dosages of Topiramate (mg/day) across different protocols and patient groups, including adults, pediatric patients, and specific epilepsy syndromes. The table compares placebo against Topiramate doses from 200 to 1,000 mg/day and includes footnotes detailing statistical significance and methodology.*

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Tbl2 (Table2)

A table titled 'Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to <10 Years' showing weight categories in kilograms alongside 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 table titled 'Risk by Indication for Antiepileptic Drugs in Pooled Analysis' presenting data on event rates per 1000 patients for placebo and drug patients across indications including epilepsy, psychiatric, and other. It shows relative risk incidence and risk difference between drug and placebo groups.*

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Tbl5 (Table5)

Table showing incidence percentages of treatment-emergent adverse reactions in monotherapy epilepsy patients aged 6 to 16 years (pediatric) and 16 years or older (adult) receiving Topiramate tablets at daily dosages of 50 mg and 400 mg. Reactions are categorized by body system and detailed for each age and dosage group.*

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Tbl6 (Table6)

A data table listing 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 adverse events under systems like nervous, gastrointestinal, psychiatric, reproductive, respiratory, skin, urinary, vision, and more, with percentages of patients reporting each reaction across treatment groups.*

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Tbl7 (Table7)

Table showing incidence of treatment-emergent adverse reactions in a study comparing placebo and Topiramate 200 mg/day. It lists various body systems and adverse reactions with corresponding percentages in placebo and Topiramate groups, indicating higher rates for Topiramate in symptoms such as fatigue, dizziness, somnolence, and weight decrease.*

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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' comparing adverse reactions between placebo and varying dosages of Topiramate tablets (200 mg/day, 600 mg/day, 1,000 mg/day). It lists adverse reactions and corresponding percentage incidences across groups.*

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Tbl9 (Table9)

A data table detailing the incidence percentages of treatment-emergent adverse reactions in placebo-controlled, add-on epilepsy trials in pediatric patients aged 2-16 years. It compares the occurrence of various adverse reactions between placebo-treated (N=101) and topiramate-treated (N=98) groups across multiple body systems and disorder categories.*

* 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.