Topiramate
Product Images NDC 71610-193

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 71610-193). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

Bottle Label 50 mg (71610 0193 53)

Topiramate USP 50 mg tablets label showing package with 60 tablets. The label includes storage instructions, manufacturer Invagen Pharmaceuticals Inc., and packager Aphena Pharma Solutions - Tennessee, LLC. The product NDC 71610-0193-53 and expiration date are also displayed. The label is primarily black text on a white background.*

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A data table titled 'Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older' showing weekly morning and evening doses of Topiramate starting at 25 mg twice daily in Week 1 and progressively increasing to 200 mg twice daily by Week 6.*

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Table showing monotherapy target total daily maintenance dosing of Topiramate for patients aged 2 to under 10 years according to weight categories. It lists minimum and maximum daily doses in mg/day, with a note specifying administration in two equally divided doses.*

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A data table titled 'Risk by Indication for Antiepileptic Drugs in Pooled Analysis' showing the incidence of events per 1000 patients among placebo and drug patients across epilepsy, psychiatric, and other indications. It also presents the relative risk and risk difference for drug patients compared to placebo patients.*

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A table presenting the incidence percentages of treatment-emergent adverse reactions in monotherapy epilepsy patients taking Topiramate tablets. Data is shown by age group (pediatric 6 to <16 years, adult ≥16 years) and daily dosage (50 mg/day and 400 mg/day). Adverse reactions are categorized by body system, with specific conditions and their incidence rates listed for each group. The table is from study TOPAMAX-EPMN-106.*

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Table showing the incidence of adverse reactions in clinical trials of Topiramate tablets at daily doses of 200 to 400 mg and 600 to 1,000 mg compared to placebo. It categorizes reactions by body system, such as general disorders, nervous system, gastrointestinal, psychiatric, reproductive, respiratory, skin, urinary, vision, and blood disorders, listing percentage rates for each group.*

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Table showing the incidence of treatment-emergent adverse reactions in Study 119a,b with Topiramate tablets (200 mg/day) compared to placebo. It lists adverse reactions by body system with percentage rates for placebo (N=92) and Topiramate (N=171), including fatigue, paresthesia, somnolence, and other reactions occurring at ≥2% in the Topiramate group and higher than placebo.*

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A table showing the incidence percentage of dose-related adverse reactions from placebo-controlled, add-on trials in adults with partial onset seizures, comparing placebo and Topiramate tablet dosages at 200 mg/day, 600-1000 mg/day. Adverse reactions listed include fatigue, nervousness, difficulty with concentration/attention, confusion, depression, anorexia, language problems, anxiety, mood problems, and weight decrease.*

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A data table titled 'Table 9' showing incidence percentages of treatment-emergent adverse reactions in placebo-controlled, add-on epilepsy trials for pediatric patients aged 2-16 years. The table compares adverse reaction rates in patients treated with placebo versus Topiramate (N=101 and N=98 respectively) across multiple body systems, including general disorders, nervous system, gastrointestinal, psychiatric, and others, reporting higher incidence in several reactions for Topiramate-treated patients.*

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Chemical structure of Topiramate showing its molecular configuration, including a sugar-like ring with multiple substituents such as methyl groups and a sulfamate group.*

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Kaplan-Meier estimates graph showing cumulative rates for time to first seizure in patients taking Topiramate at dosages of 50 mg/day and 400 mg/day. The x-axis represents time in days, and the y-axis shows cumulative seizure rates. The graph compares outcomes for the two dosages.*

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Table presenting efficacy results from double-blind, placebo-controlled, add-on epilepsy trials of topiramate across various dosages (200 to 1000 mg/day). Data includes median percent reduction in seizures and percent responders for adult and pediatric studies, covering partial onset seizures, primary generalized tonic-clonic seizures, and Lennox-Gastaut syndrome. Comparative statistics versus placebo are also noted.*

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Aphena Pharma Solutions (TN)

* 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.