Product Images Topiramate

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The following 13 images provide visual information about the product associated with Topiramate NDC 43353-695 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 25mg - 43353 695

Bottle Label 25mg - 43353 695

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Table 1 describes a monotherapy titration schedule for adults and pediatric patients aged 10 years and older. The table outlines the morning and evening doses to be administered for each week, starting with 25mg in the morning and 5mg in the evening during Week 1, and gradually increasing the dosage up to 200mg in the morning and 0mg in the evening during Week 6.*

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This is a table that shows the risk associated with using antiepileptic drugs based on indication. The table includes the number of patients who received a placebo and the number who received the drug, the relative risk, incidence, and risk difference. The indications included are epilepsy, psychiatric conditions, and other indications. The relative risk and incidence are highest for psychiatric indications. The risk difference is highest for epilepsy. The total risk for all indications is shown at the bottom of the table.*

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The text describes a table (Table 5) that shows the incidence of treatment-emergent adverse reactions for epilepsy patients treated with monotherapy using topiramate tablets of 50mg/day or 400mg/day. The table is divided into various body systems such as nervous system disorders and gastrointestinal system disorders, among others. The adverse reactions listed in the table have an incidence rate of at least 2% in any topiramate group, and the rate is greater in the 400mg/day Topiramate group than in the 50mg/day Topiramate group. The data collected includes information for both pediatric (6 to <16 years) and adult patients (216 years) with epilepsy.*

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Topiramate Tablets Dosage (mg/day) along with its adverse reactions are listed in the table. The patients were receiving 1 to 2 concomitant antiepileptic drugs along with topiramate or placebo. The table shows the percentage of patients reporting a given adverse reaction. Adverse reactions reported by at least 1% of patients in the topiramate 200 to 400 mg/day group and more common than in the placebo group are listed in this table. Some of the common adverse reactions reported are fatigue, dizziness, somnolence, nervousness, difficulty with memory, anorexia, depression, vision abnormality, diplopia, weight decrease, paresthesia, nystagmus, etc.*

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This is a table presenting incidence rates of treatment-emergent adverse reactions in a study where patients with epilepsy were either given topiramate or a placebo. The adverse reactions are grouped according to affected body systems, and the percentage of patients in either group reporting each reaction is given. The adverse reactions listed are those that were reported by at least 2% of patients in the topiramate 200 mg/day group and were more common than in the placebo group.*

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This table shows the incidence of dose-related adverse reactions in adults with partial onset seizures treated with topiramate tablets at different dosages in comparison to placebo. The adverse reactions include fatigue, nervousness, difficulty with concentration/attention, confusion, depression, anorexia, language problems, anxiety, mood problems, and weight decrease. The study did not conduct dose-response studies for other adult medications or pediatric medications.*

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The table provides the incidence of treatment-emergent adverse reactions in placebo-controlled, add-on epilepsy trials with pediatric patients between the ages of 2-16 years. The adverse reactions that occurred in at least 1% of topiramate-treated patients and occurred more frequently in topiramate-treated than placebo-treated patients are included. The table includes adverse reactions by body system, such as general disorders, cardiovascular disorders, central & peripheral nervous system disorders, gastrointestinal system disorders, psychiatric disorders, reproductive disorders, respiratory system disorders, skin and appendage disorders, urinary system disorders, vision disorders, and white cell and RES disorders. Each adverse reaction is presented with its respective incidence percentage in the placebo or topiramate group. Patients in these trials were receiving one to two concomitant antiepileptic drugs in addition to topiramate or placebo.*

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The text provides efficacy results in double-blind, placebo-controlled, add-on epilepsy trials. It includes different target Topiramate dosages for partial onset seizures in adults, primary generalized tonic-clonic seizures, and Lennox-Gastaut syndrome. The median % reduction and % responders are reported. There are also comparisons with the placebo and the percentage of patients who experienced improvement in seizure severity. Dosage information is provided for some protocols based on subject weight.*

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.