Gabapentin
Product Images NDC 50436-0813

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Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 50436-0813). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

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This is a dosage table for Gabapentin based on renal function. The table shows the dosages for patients based on their creatinine clearance rates. The dosage ranges from 100mg to 3600mg per day and can be taken up to three times a day. Patients on hemodialysis should receive maintenance doses and a supplemental post-hemodialysis dose. For patients with a creatinine clearance rate of less than 15ml/min, the daily dosage should be reduced proportionally.*
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The text seems to be a fragment of a medical record or report. It is not clear what CLor stands for, but it may be a measure of kidney function. The text suggests that some female patients were evaluated based on their weight and age, and serum creatinine levels were measured (72 mg/dl). However, the context and purpose of the evaluation are not provided, so no definitive conclusion can be drawn.*
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FDA Label Image

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This is a table showing adverse reactions in pooled placebo-controlled trials in Postherpetic Neuralgia. Gabapentin and Placebo were given to 336 and 227 individuals respectively. The table shows the percentage (%) of adverse reactions. The adverse reactions are categorized into various systems including body as a whole, digestive system, metabolic and nutritional disorders, nervous system, respiratory system, and special senses. The adverse reactions include asthenia, infection, accidental injury, diarrhea, dry mouth, constipation, nausea, vomiting, peripheral edema, weight gain, hyperglycemia, dizziness, somnolence, ataxia, abnormal thinking, abnormal gait, incoordination, pharyngitis, amblyopia, conjunctivitis, diplopia, and otitis media. *
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This is a table displaying adverse reactions in epilepsy patients over 12 years of age who were taken Gabapentin compared to Placebo. The table contains a list of various adverse reactions such as fatigue, increased weight, back pain, dyspepsia, somnolence, dizziness, pharyngitis, coughing, and impotence. Amblyopia, which is often described as blurred vision, has also been mentioned.*
FDA Label Image

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This is a table showing the adverse reactions in a placebo-controlled add-on trial in pediatric epilepsy patients between the ages of 3 to 12 years who received either Gabapentin or placebo along with background antiepileptic drug therapy. The table displays the number of patients and percentage of patients experiencing each adverse reaction. The adverse reactions listed are body ash, weakened immune system, fever, increased weight, fatigue, nausea and/or vomiting, somnolence, hostility, emotional lability, dizziness, hyperkinesia, bronchitis, and respiratory infection.*
FDA Label Image

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FDA Label Image

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This is a table showing the duration, dosages, and number of patients in two controlled studies for PHN using Gabapentin. The target dose for Gabapentin was administered in 3 divided doses (TID). Study 1 lasted 8 weeks and involved 113 patients receiving Gabapentin and 116 receiving Placebo. Study 2 lasted 7 weeks and involved 223 patients receiving Gabapentin at dosages of 1800 or 2400 mg/day and 11 receiving Placebo. The total number of patients was 227 and only 3% received placebo.*
FDA Label Image

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This is a graph labeled as "Figure 3" displaying the proportion of responders in controlled PHN studies, where responders are patients who experienced more than 50% reduction in pain score at endpoint. One study is labeled "Study" while the other is labeled "Study 2". There is a significant difference indicated by "p<0.001" and "4p<0.001". The percentage of responders in Study is 34%. It is difficult to interpret the text at the end due to the lack of context, so it may be "GEP 3600 GBP 1800 GBP 2400" or "6EP 3600 61% 1800 6P 2400".*
FDA Label Image

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FDA Label Image

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This is a description of a medication called Gabapentin that comes in capsule form with a strength of 100 mg. The medication is identified by NDC code 50436-0813-1. Other information such as dosage and prescription details are not available due to incomplete text caused by .*

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