Gabapentin
Product Images NDC 53002-1472

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 53002-1472). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rpk 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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This is a dosage table for Gabapentin based on a patient's renal function (creatinine clearance). The table provides information on the total daily dose range given for each regimen (TID, BID, and QD) based on the patient's creatinine clearance level. The table also provides supplemental post-hemodialysis doses for patients on hemodialysis. The dosage should be adjusted for patients with creatinine clearance <15 mL/min. The Cockcroft and Gault equation can be used to estimate CLCr in patients with stable renal function.*

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This is a table presenting the risk and relative risk of antiepileptic drugs for different indications (epilepsy, psychiatric and other) in comparison to placebo patients, based on a pooled analysis. The risks are presented as events per 1000 patients, and the relative risk is calculated as the incidence of events in drug patients compared to placebo patients. The risk difference is also presented as additional drug patients with events per 1000 patients.*

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This table shows the results of a study on adverse reactions in patients with postherpetic neuralgia who were treated with Gabapentin or Placebo. The table lists the different reactions and the percentage of patients who experienced them in each group. Some of the reactions include asthenia, infection, accidental injury, diarrhea, and abnormal thinking. Gabapentin had a higher incidence of dizziness and somnolence compared to placebo. Blurred vision was reported as a special sense reaction.*

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This is a table summarizing the adverse reactions reported in pooled placebo-controlled add-on trials in epilepsy patients above 12 years old for Gabapentin and Placebo. The table shows the number of patients and the percentage of reported adverse reactions in each category. The adverse reactions for Gabapentin included fatigue, somnolence, dizziness, pharyngitis, and impotence, among others. The adverse reactions for Placebo included dyspepsia, dry mouth, and dental abnormalities, among others. Amblyopia was a commonly reported adverse reaction for Gabapentin patients and often described as blurred vision.*

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This is a table showing the adverse reactions in a placebo-controlled add-on trial in pediatric epilepsy patients aged 3 to 12 years who were given Gabapentin®. The table compares the occurrence of adverse reactions for the Gabapentin® group (N=110) and the Placebo group (N=128). Adverse reactions experienced by patients in the Gabapentin® group include body weakness, fever, increased weight, fatigue, nausea and/or vomiting, somnolence, hostility, emotional labile, dizziness, hyperkinesia, Bronchitis, and respiratory infection. The placebo group experienced a lower rate of adverse reactions in general.*

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This text provides a table with information on controlled PHN studies, including the duration, dosages, and number of patients in each study. The table includes two studies, with varying target doses of Gabapentin given in three divided doses (TID). The total number of patients involved in the studies was 336 for Gabapentin and 227 for Placebo.*

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The text presents a figure that shows the percentage of patients with more than a 50% reduction in pain score in controlled PHN studies. The figure includes two studies, but the information is not clear enough to determine the overall outcomes of the studies. The text also presents some numbers, possibly dosages or cost of the medication used in the studies.*

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