Topiramate
Product Images NDC 10544-489

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 10544-489). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Blenheim Pharmacal, 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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Table 2 (Part 1)

This appears to be a table showing the adverse reactions reported for different dosages of Topiramate. The adverse reactions are grouped by body system, including the body as a whole, the central and peripheral nervous system, the gastrointestinal system, and the liver and biliary system. The dosages that were studied were 50mg/day and 400mg/day. The adverse reactions reported include asthenia, leg pain, chest pain, paresthesia, dizziness, ataxia, hypertonia, diarrhea, constipation, gastritis, dry mouth, gastroesophageal reflux, Gamma- GT Increased, and weight decrease.*

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Table 2 (Part 2)

This is a list of adverse reactions and disorders that were reported by patients during a study. These reactions include psychiatric disorders such as depression, anxiety, and mood problems. Patients also reported physical disorders such as anemia, urinary tract infections, and respiratory disorders such as bronchitis and rhinitis. Other reported disorders include cystitis, dyspnea, pruritus, and taste perversion. The percentages represent the number of patients who reported each adverse reaction.*

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Table 3 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 03)

This text provides a table showing the frequency of reported adverse reactions to a medication among 57 patients. The table lists various body systems and disorders, along with the corresponding number and percentage of patients who reported each disorder. The disorders range from fever and diarrhea to paresthesia and alopecia. Patients could report more than one disorder and could be included in multiple categories.*

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Table 4 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 04)

This text presents a table showing the Topiramate dosage and the reported adverse reactions based on body systems, including general disorders, nervous system, gastrointestinal system, psychiatric disorders, urinary system, and others. The values represent the percentage of patients who reported a given adverse event, and patients may have reported more than one adverse reaction during the study. Adverse reactions reported by at least 19 of patients in the Topiramate 200-400 mg/day group and more common than in the placebo group are listed in the table.*

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Table 5 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 05)

This text provides a list of possible adverse reactions to Topiramate, a migraine and epilepsy medication, with corresponding dosages (200mg/d). The reactions are listed by body system and number of patients reporting the reaction. The percentages represent patients reporting one or more reactions during the study. The document also notes that patients in the study were taking additional antepileptic drugs along with the topiramate or placebo. The provided reactions that were listed under the Topiramate 200mg/day group and were more common than in the placebo group.*

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Table 6 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 06)

This text presents a table displaying the adverse reactions at different dosages of the drug Topiramate. The dosages evaluated were 200mg/day, 400mg/day, and 600-1000mg/day. The adverse reactions include nervousness, difficulty with concentration/attention, confusion, depression, anorexia, language problems, anxiety, mood problems and weight decrease. The table includes the number of patients (N) and the frequency of reactions (%). No dose-response studies were conducted for other adult indications or pediatric indications.*

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Table 7 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 07)

This is a list of adverse reactions reported by patients in a clinical trial that was evaluating Topiramate compared to a placebo. The reactions were classified into different body systems and included fatigue, injury, hypertension, gait abnormality, dizziness, weight changes, skin disorders, urinary incontinence, and others. The percentage of patients reporting each reaction is provided. Patients in the trial were also taking one or two other antiepileptic drugs in addition to Topiramate or placebo.*

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Structure Of Topiramate (D3343e6b 6ff3 4ba4 A138 4636dd463fec 08)

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Figure 1 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 09)

The text is a table with the title "Cumulative Rates for Time to First Seizure" and two rows of data showing the results of a study on topiramate (an anti-epileptic drug) for two different dosages. The first dosage of 20 mg/day had a cumulative rate of 2% and the second dosage of 400 mg/day had a sample size of 226 with no further information provided.*

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Table 12 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 10)

This text provides a chart of target topiramate dosages and the corresponding efficacy results for various dosages in the treatment of partial onset seizures in adults and pediatric patients, as well as primary generalized tonic-clonic seizures and Lennox-Gastaut syndrome. The chart includes median percentage reduction and percentage responders for each dosage level. Additionally, the text reports improvements in seizure severity and provides information on protocol-specific target dosages.*

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Glenmark Logo (D3343e6b 6ff3 4ba4 A138 4636dd463fec 11)

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Label Graphic-50mg 60s (D3343e6b 6ff3 4ba4 A138 4636dd463fec 12)

This is a description of a medication labeled as Topiramate tablets USP 50mg. The tablets are packaged in bottles containing 60 tablets, and the lot number is BPOT00000D. The medication should be stored at a controlled room temperature of 20-25°C (68-77°F), protected from moisture, and kept out of reach of children. The tablets are manufactured by Glenmark Generics Inc. and packaged by Blenhelm Pharmacal, Inc. There are also additional labels with different lot numbers and expiration dates for the same medication and dosage.*

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Label Graphic-100mg 60s (D3343e6b 6ff3 4ba4 A138 4636dd463fec 13)

Topiramate Tablets, USP 100mg is a medication available in the form of tablets that are sold in bottles containing 60 tablets. Each tablet contains 100mg of Topiramate. The product should be stored at a controlled room temperature of 20-25°C and should be kept away from children. The Lot number and expiration date are printed on the packaging of the tablets. A dosage guide is included in the package and should be followed for correct usage of the medication. The manufacturer's details and NDC number are also mentioned.*

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