Product Images Topiramate

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The following 13 images provide visual information about the product associated with Topiramate NDC 43353-696 by Aphena Pharma Solutions - Tennessee, Llc, such as packaging, labeling, and the appearance of the drug itself. This resource could be helpful for medical professionals, pharmacists, and patients seeking to verify medication information and ensure they have the correct product.

Bottle Label 100mg - 43353 696

Bottle Label 100mg - 43353 696

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The text appears to be a medication titration schedule for adults and pediatric patients, showing the recommended dosage in milligrams for each week for a particular medication. It is likely used by healthcare professionals as a guide for gradually increasing the dosage of the medication over time.*

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This is a table that provides the recommended total daily maintenance dosing for patients between 2 to less than 10 years of age who are receiving monotherapy. The dosing is based on the weight of the patient and ranges from 150mg/day to 250mg/day depending on the weight category. The dosing is administered in two equally divided doses.*

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Table 4 shows the relative risk and incidence of events in patients taking antiepileptic drugs for different indications. The table includes data on patients taking placebo, the number of events per 1000 patients, and the risk difference. For patients with epilepsy, there is a higher incidence of events in those taking the drug compared to placebo. The same is true for patients with psychiatric indications. Conversely, patients with other indications had similar event rates between the drug and placebo. The total risk difference between drug and placebo patients across all indications is 19 per 1000 patients.*

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The table shows the incidence of treatment-emergent adverse reactions in monotherapy epilepsy patients who were administered Topiramate tablets daily at 50 mg/day and 400 mg/day dosages. The adverse reactions with an incidence rate of 2% or more in any Topiramate group, where the rate in the 400 mg/day Topiramate group was greater than the rate in the 50 mg/day Topiramate group for adults (216 years) and pediatric (6 to <16 years) patients in Study TOPAMAX-EPMN-106 were recorded. The table includes adverse reactions grouped by different body systems, such as nervous system disorders, metabolic and nutritional disorders, respiratory system disorders, and skin and appendages disorders. Percentages were calculated using the number of subjects in each group as the denominator.*

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The text provides a table of adverse reactions reported by patients receiving topiramate tablets in dosages of 200 to 400 mg/day as an add-on/adjunctive treatment for epilepsy. The table categorizes the adverse reactions by body system and shows the percentage of patients reporting each reaction. The most frequently reported reactions include fatigue, dizziness, weight decrease, somnolence, nervousness, difficulty with memory, anorexia, and depression. Patients may have reported more than one adverse reaction during the study, and some cases were common compared to the placebo group.*

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The text describes a table with the incidence of treatment-emergent adverse reactions in a study comparing the effects of topiramate tablets dosage (200mg/day) to placebo. The table lists various body systems and specific adverse reactions that were present in at least 2% of patients in the topiramate group, but not in the placebo group. The adverse reactions are classified under several categories including General Disorders, Nervous System Disorders, Gastrointestinal System Disorders, Metabolic and Nutritional Disorders, Psychiatric Disorders, Respiratory System Disorders, Urinary System Disorders, and Vision Disorders. The table also contains some additional information regarding the study setup and data interpretation.*

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The table shows the incidence of dose-related adverse reactions from placebo-controlled, add-on trials in adults with partial onset seizures. The study involved the use of Topiramate at different dosages ranging from 200mg/day to 1000mg/day. The adverse reactions were fatigue, nervousness, difficulty with concentration/attention, confusion, depression, anorexia, language problems, anxiety, mood problems, and weight decrease. No dose-response studies were conducted for other adult medications or pediatric medications.*

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This is a table listing the incidence of treatment-emergent adverse reactions in pediatric patients with epilepsy, ranging from ages 2 to 16, who were part of placebo-controlled add-on trials with topiramate. The table categorizes the reactions by body system and lists the adverse reaction along with the percentage of patients experiencing them. The reactions are compared between the placebo and topiramate groups, with reactions that occurred in at least 1% of topiramate-treated patients and occurred more frequently in topiramate-treated than placebo-treated patients listed.*

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The text describes a figure labeled as "Figure 1" which displays cumulative rates for time to first seizure. The figure includes two groups with sample sizes of 234 and 236, respectively, treated with different dosages of Topramate (50 mg/day and 400 mg/day). The x-axis of the figure shows time in days and the y-axis shows cumulative rates. However, since the text does not provide any useful or readable information regarding the actual cumulative rates displayed on the graph, no further description can be provided.*

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This is a table (Table 15) containing efficacy results of add-on epilepsy trials that were double-blind and placebo-controlled, based on different dosages of topiramate (ranging from 200 to 1000 mg/day). The trials were conducted on both pediatric and adult patients with various types of seizures. The results are presented in terms of median percentage reduction and percentage responders for each trial. The table also includes data on the comparison with the placebo and the percentage of patients who showed improvement in seizure severity.*

Aphena Pharma Solutions - TN - Aphena

Aphena Pharma Solutions - TN - Aphena

* The product label images have been analyzed using a combination of traditional computing and machine learning techniques. It should be noted that the descriptions provided may not be entirely accurate as they are experimental in nature. Use the information in this page at your own discretion and risk.