Topiramate Tablet
Product Images NDC 31722-182

Product Visual Gallery

This gallery contains 27 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 31722-182). 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-500s (100 mg 500s)

This is a prescription drug called Topiramate in tablet form and each tablet contains 100mg. It is important to verify prescription before dispensing and each patient should be provided with a medication guide. The tablets should be stored in a tight container and protected from moisture at a temperature of 20°C to 25°C. It is manufactured by Ascent Pharmaceuticals and distributed by Camber Pharmaceuticals. A medication guide is available at a specific website.*

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100mg-60s (100 mg 60s)

This text is a medication label for the drug Topiramate, in the form of tablets, with a dosage of 100 mg. It includes cautions for dispensing, instructions to provide a medication guide to patients, storage requirements, and manufacturing information.*

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200mg-500s (200 mg 500s)

This is a description of a medication called Topiramate in tablet form with a strength of 200 mg. It is important for the pharmacist to verify the prescription before dispensing and to provide a medication guide to each patient. The medication should be kept in a tight container at a temperature between 20° to 25°C and protected from moisture. It is manufactured by Ascent Pharmaceuticals, Inc. and distributed by Camber Pharmaceuticals, Inc. More information regarding dosage and prescribing should be found in the accompanying product literature.*

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200mg-60s (200 mg 60s)

This is a description of a medication called "Topiramate Tablets, USP" with a strength of 200 mg. It is manufactured by Ascent Pharmaceuticals in Central Islip, NY and distributed by Camber Pharmaceuticals in Piscataway, NJ. The medication guide should be given to each patient and the prescription should be verified by the pharmacist before dispensing. The tablets should be stored in a tight container with a child-resistant closure at 20° to 25°C (68° to 77°F) and protected from moisture. The medication guide is available at camberpharma.com/medication.*

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25mg-500s (25 mg 500s)

This is a description of Topiramate Tablets containing 25 mg of the active ingredient. The caution advises to verify the prescription before dispensing and provides a warning to keep out of reach of children. The medication guide should be dispensed to each patient. The tablets should be stored in a tightly closed container, protected from moisture, and kept at a temperature of 20° to 25°C (68° to 77°F). The manufacturing company is Ascent Pharmaceuticals, Inc. located in Central Islip, NY and the medicine is manufactured for Camber Pharmaceuticals, Inc. in Piscataway, NJ 08854.*

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25mg-60s (25 mg 60s)

This is a description for a medication called Topiramate, which comes in the form of 25 mg tablets. The prescription must be verified before dispensing to the patient, and the pharmacist should provide each patient with a separate medication guide. This medication should be kept in a tightly sealed container with a child-resistant closure, and stored at room temperature. It should be protected from moisture and kept out of reach of children. The drug is manufactured by Ascent Pharmaceuticals and distributed by Camber Pharmaceuticals. For additional information on dosages and prescribing information, refer to the product literature.*

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50mg-500s (50 mg 500s)

Topiramate Tablets USP is a medication used to treat certain types of seizures in adults and children. It contains 50 mg of topiramate per tablet and comes in a bottle with 500 tablets. The medication guide should be provided to each patient by the pharmacist. It should be stored at room temperature and protected from moisture. The manufacturer is Camber Pharmaceuticals, Inc.*

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50mg-60s (50 mg 60s)

This is the description: Topiramate Tablets, USP by Camber Pharmaceuticals are available in a bottle of 60 tablets. Each tablet contains Topiramate USP 50mg. These tablets are for Rx only and should be dispensed with a medication guide. For dosage and other prescribing information, refer to the accompanying product literature. To store this medication, it should be kept in a tight container, away from moisture and out of children's reach. Camber Pharmaceuticals manufactured these tablets for Ascent Pharmaceuticals, Inc at Central Islip, New York.*

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Common-side Effects (Common Side Effects)

This appears to be a list of possible symptoms that may be experienced due to a medical condition or medication. These symptoms include tingling of the arms and legs, nausea, a change in the way foods taste, diarrhea, weight loss, nervousness, upper respiratory tract infection, speech problems, tiredness, dizziness, sleepiness or drowsiness, slow reactions, difficulty with memory, pain in the abdomen, fever, abnormal vision, and decreased feeling or sensitivity, especially in the skin.*

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Figure1 (Fig1)

This appears to be a figure from a scientific study showing the Kaplan-Meier estimates of cumulative rates for time to first seizure in Study 1. The figure includes two medication labels, "Toiamate 50" and "Topramas 400," and the y-axis represents the cumulative rates for time to first seizure. The x-axis represents time in days. No further information can be obtained from this text.*

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Fig2 (Fig2)

The text describes a figure (Figure 2) that shows the reduction in 4-week migraine headache frequency based on studies 11 and 12 for both adults and adolescents. The figure presents a graph and indicates that there was a significant reduction in migraine headache frequency with a p-value of 0.001. No further information is available.*

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Metabolic-acidosis Symptoms (Metabolic Acidosis Symptoms)

This text seems to describe several symptoms that an individual might experience. The symptoms include feeling tired and changes in heartbeat. Additionally, the person may not feel hungry and have trouble thinking clearly. It is unclear what the cause of these symptoms might be, but they could be related to a variety of conditions or illnesses.*

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Structure (Structure)

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Symptom (Symptom)

This text appears to be a list of warning signs for changes in behavior or mood that may indicate a person is at risk for suicide. It includes symptoms such as thoughts of suicide, attempts to commit suicide, worsening depression or anxiety, agitation or restlessness, panic attacks, insomnia, irritability, and aggressive or violent behavior. Additionally, it notes that an extreme increase in activity and talking (mania) or other unusual changes in behavior or mood may also be potential warning signs. These symptoms, if experienced, should be taken seriously and may require immediate medical attention.*

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Tab1 (Tab1)

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Tab10 (Tab10)

This is a table summarizing the interactions of AED (Antiepileptic drugs) with Topiramate. It shows that the plasma concentration of Topiramate increased by 25% in some patients who were on a five times a day dosing regimen of Phenytoin. It also indicates that a metabolite of Carbamazepine is not administered by Topiramate. In addition, the table shows that there was no more than a 10% change in Lasca concentration due to Topiramate interaction.*

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Tab11 (Tab11)

Table 11 shows the summary of topiramate dosage during stabilization periods of six double-blind, placebo-controlled, adjunctive trials in adults with partial-onset seizures. The target dosage for topiramate was 200 mg/day. The text mentions that dose response studies were not conducted for other indications or pediatric partial-onset seizures. The placebo dosages are given as the number of tablets, varying from 34 tablets/day for Protocol 34 to 6 tablets/day for Protocols 1 and 4, to § tablets/day for Protocols 5 and 6, and 10 tablets/day for Protocol 2.*

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Tab13 (Tab13)

This is a table showing the percent reduction in average monthly attack rate from baseline to the last 12 weeks of double-blind phase in Study 13, analyzed using the Intent-to-Treat Analysis Set. The table includes data for the placebo group and two topiramate groups (50 mg/day and 100 mg/day). The median baseline value is 56, and the median value during the last 12 weeks of the double-blind phase is between 51 and 35. The percent reduction ranges from -8% to -3%. The statistical analysis used a 2-factor ANCOVA model and included monthly migraine attack rate as a covariate. Adjusted p-values were calculated using the Holm-Bonferroni multiple comparison procedure.*

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Tab2 (Tab2)

This is a table showing the recommended total daily maintenance dosing for patients aged 2 to 9 years old who are undergoing monotherapy, based on their weight. The minimum and maximum maintenance doses are given for weight ranges from up to 11 kg to greater than 38 kg, with corresponding total daily doses in milligrams per day. The medication should be administered in two equally divided doses.*

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Tab3 (Tab3)

This is a table showing the titration schedule for preventive treatment of migraine in patients 12 years of age and older. It includes the morning and evening doses for each week for a span of four weeks. The medication dosage increases each week to gradually reach the maintenance dose.*

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Tab4 (Tab4)

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Tab5 (Tab5)

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Tab6 (Tab6)

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Tab7 (Tab7)

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Tab8 (Tab8)

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Tab9 (Tab9)

Table 9 displays the adverse reactions in pooled double-blind pediatric studies for preventing migraine in patients aged 12-17 years. The table compares the Toprats dosage of 100mg/day with the Somgaay's dosage of 16. The adverse reactions are categorized under different systems, including the central and peripheral nervous system, gastrointestinal system, respiratory system, among others. The reactions include fatigue, dizziness, nausea, taste perversion, etc. In another study, 55 adolescent patients aged 13 to 16 years were assessed for adverse reactions, but the incidence rate is not stated due to insufficient information. The text seems to be from a medical report on drug reactions in pediatric patients.*

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Table12 (Table 12)

The text appears to be a table showing efficacy results in double-blind, placebo-controlled, adjunctive epilepsy trials with different target topiramate dosages. The table includes the study number, target dosage, median % reduction, % responders, and improvement percentages for different types of seizures, such as primary generalized tonic-clonic and Lennox-Gastaut syndrome. There are also comparisons with placebo and reported dosages for certain studies based on subjects' weight.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.