Gabapentin Capsule
Product Images NDC 70518-4261

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 70518-4261). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack 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.

FDA Label Image

Remedy_label (Remedy Label)

This is a description of a Gabapentin medication in capsule form with a strength of 100 mg. It comes in a quantity of 30 tablets and is prescription only. The medicine is manufactured by Cipla Ltd in Kurkumbh, India, with reference to NDC numbers 70518-4261-00 and 69097-0813-07. The expiration date and lot number are left blank. The text also advises keeping the medication out of reach of children, provides storage conditions, and mentions repackaging by RemedyRepackinc., based in Indiana, Pennsylvania. For usage guidelines, it directs to the package insert.*

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This text provides information on Gabapentin dosage based on renal function, including recommendations for total daily doses based on creatinine clearance levels. The table outlines different dose regimens for patients with varying levels of renal function, with adjustments for hemodialysis patients as well. It also offers guidance on how to estimate creatinine clearance using the Cockcroft and Gault equation, especially valuable for outpatients.*

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This text provides a comparison of risks associated with different indications for antiepileptic drugs. It presents data on the number of patients with events per 1,000 patients for both placebo and drug treatment groups, along with relative risk and risk differences. The analysis covers indications such as epilepsy, psychiatric conditions, and others. The information can be used to evaluate the risk-benefit profile of antiepileptic drugs for specific indications.*

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This is a table showing adverse reactions in pooled placebo-controlled trials for postherpetic neuralgia with Gabapentin compared to Placebo. The table includes percentages of reported adverse reactions for various body systems, such as Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses. Adverse reactions include symptoms like asthenia, diarrhea, dizziness, weight gain, and blurred vision. The data can be useful for understanding the potential side effects of Gabapentin in this context.*

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This is a table presenting adverse reactions reported in pooled placebo-controlled add-on trials in epilepsy patients over 12 years of age using Gabapentin. The table lists various adverse reactions and their percentages compared to the placebo group. Common adverse reactions included fatigue, increased weight, back pain, peripheral edema, somnolence, dizziness, and dry mouth. Additionally, it notes cardiovascular, digestive, nervous, respiratory, skin, urogenital, and special senses-related adverse reactions. The table also mentions that amblyopia was often described as blurred vision.*

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This text provides information on adverse reactions in a placebo-controlled add-on trial for pediatric epilepsy patients aged 3 to 12 years involving Gabapentin®. The table lists the percentages of various adverse reactions experienced by patients in the Gabapentin group compared to the Placebo group, including body weakness, viral infection, fever, increased weight, fatigue, nausea, vomiting, somnolence, hostility, emotional lability, dizziness, hyperkinesia, and respiratory issues like bronchitis and respiratory infections. These adverse reactions are monitored alongside background antiepileptic drug therapy.*

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This text provides information on controlled postherpetic neuralgia (PHN) studies involving the use of gabapentin. It includes details on the duration of the studies, dosages administered (in mg/day), and the number of patients receiving gabapentin and placebo in each study. The total number of patients across the studies is also provided. The gabapentin was given in three divided doses (TID) in these studies.*

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This text appears to be a medication schedule or treatment plan. It includes the usage of Gabapentin and mentions the dosage of 3000 mg daily. It suggests a specific routine with a duration of weeks.*

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This is a description of results showing the proportion of responders (patients with over 50% reduction in pain score) in controlled PHN studies. The data provided is from Study 1 and Study 2, displaying a 34% rate of responders. The statistical significance of these findings is denoted by p<0.001. The treatments listed include GEP 3600, GBP 1800, and GBP 2400.*

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