Topiramate
Product Images NDC 31722-281

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 31722-281). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber Pharmaceuticals, Inc., 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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100mg (100 60)

Topiramate Tablets USP 100 mg bottle label from Camber Pharmaceuticals, Inc. The label includes the NDC 31722-280-60 and instructs pharmacists to dispense with the attached medication guide. It states the bottle contains 60 tablets, is prescription only, and includes storage instructions and manufacturer details.*

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200mg (200 60)

Topiramate Tablets, USP 200 mg label from Camber Pharmaceuticals, Inc. The label shows 60 tablets per bottle, NDC 31722-281-60, with instructions to dispense with attached medication guide and typical storage instructions. Manufactured for Camber Pharmaceuticals and by Ascent Pharmaceuticals.*

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25mg (25 60)

Topiramate Tablets USP 25 mg carton label by Camber Pharmaceuticals, Inc. The label includes dosing instructions, storage conditions, and manufacturer details. The package contains 60 tablets and is marked for Rx only use.*

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50mg (50 60)

Packaging label for Topiramate Tablets, USP 50 mg by Camber Pharmaceuticals, Inc. The label includes the NDC 31722-279-60 and specifies a quantity of 60 tablets. It instructs pharmacists to dispense with an attached medication guide and notes storage instructions and manufacturer information for Camber Pharmaceuticals in Piscataway, NJ, and Ascent Pharmaceuticals in Central Islip, NY.*

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Fig1 (Fig1)

A Kaplan-Meier survival curve chart showing cumulative rates for time to first seizure over 500 days. It compares two Topiramate dosage groups, 50 mg/day and 400 mg/day, indicated by solid and dashed lines respectively, with cumulative seizure rates plotted on the y-axis against time in days on the x-axis.*

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Struct (Struct)

Chemical structure of the active pharmaceutical ingredient Topiramate. The diagram shows the molecular connectivity and functional groups characteristic of Topiramate.*

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Tbl1 (Table1)

A data table titled 'Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older' showing morning and evening doses for Weeks 1 through 6, with doses increasing from 25 mg/25 mg in Week 1 to 200 mg/200 mg by Week 6.*

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Tbl (Table12)

Table titled 'Summary of AED Interactions with Topiramate' showing the effects of co-administered antiepileptic drugs (AEDs) on AED and topiramate concentrations. It lists phenytoin, carbamazepine, CBZ epoxide, valproic acid, phenobarbital, primidone, and lamotrigine with notes on whether their plasma concentrations are decreased, not changed, or not evaluated when combined with topiramate.*

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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'. It lists various protocols with corresponding stabilization doses, placebo counts, and target topiramate dosages in mg/day, detailing mean and median doses for each protocol and dosage level.*

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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 responders for Topiramate at various dosages (200 to 1000 mg/day and >6 mg/kg/day) across multiple study protocols including partial onset seizures in adults and pediatric patients, primary generalized tonic-clonic, and Lennox-Gastaut syndrome. The table compares results for placebo and Topiramate treatment groups.*

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Tbl2 (Table2)

A table titled 'Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to <10 Years' listing weight ranges in kilograms alongside minimum and maximum total daily doses of medication in mg/day. It includes dosing guidance for weight categories from up to 11 kg through greater than 38 kg, with doses administered in two equally divided doses.*

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Tbl4 (Table4)

A table titled 'Risk by Indication for Antiepileptic Drugs in Pooled Analysis' showing comparative event rates per 1000 patients for placebo and drug groups across indications including Epilepsy, Psychiatric, Other, and Total, with relative risk incidence and risk differences detailed.*

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Tbl5 (Table5)

Table presenting the incidence percentages of treatment-emergent adverse reactions in monotherapy epilepsy patients treated with Topiramate. Data is segmented by age group (pediatric 6 to <16 years, adult ≥16 years) and daily dosage (50 mg/day and 400 mg/day). It covers multiple body systems and specific adverse reactions, showing higher rates notably in the 400 mg/day groups.*

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Tbl6 (Table6)

Data table presenting adverse reactions by body system for Topiramate tablets at dosages 200 to 400 mg/day and 600 to 1,000 mg/day versus placebo. It shows percentages of patients experiencing various side effects across categories like nervous system disorders, gastrointestinal issues, psychiatric disorders, and more, comparing different dosage groups and placebo.*

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Tbl7 (Table7)

A data table showing the incidence of treatment-emergent adverse reactions in a clinical study comparing placebo and Topiramate 200 mg/day. The table lists adverse reactions by body system with percentages of patients affected in each group, including general disorders, cardiovascular, nervous system, gastrointestinal, psychiatric, respiratory, urinary, and vision disorders.*

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Tbl8 (Table8)

A data table showing the incidence percentages of dose-related adverse reactions from placebo-controlled, add-on trials in adults with partial onset seizures. The table compares adverse reactions for placebo and three dosages of Topiramate tablets (200 mg/day, 600-1,000 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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Tbl9 (Table9)

A data table showing the incidence percentage of treatment-emergent adverse reactions in placebo-controlled, add-on epilepsy trials in pediatric patients aged 2 to 16 years. The table compares adverse reaction rates between placebo (N=101) and Topiramate (N=98) treatment groups, listing various body system disorders and their corresponding incidence percentages, highlighting reactions occurring at least 1% more frequently in Topiramate-treated patients.*

* 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.