Gabapentin
Product Images NDC 50436-0813

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.

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A table titled 'Gabapentin Dosage Based on Renal Function' showing dosage adjustments for gabapentin based on renal function measured by creatinine clearance (mL/min). It includes total daily dose ranges (mg/day) and dose regimens (mg) for varying renal function categories, along with a section on post-hemodialysis supplemental doses (mg). Footnotes explain dose reduction for low creatinine clearance and dosing guidance for hemodialysis patients.*

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Mathematical formula calculating creatinine clearance (CLCr) based on age, weight, serum creatinine, and a factor for female patients. This type of formula is often used in dosing calculations relevant to pharmacology.*

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A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' presenting the risk metrics for epilepsy, psychiatric, other indications, and total patient categories. It includes columns for placebo patients with events per 1000, drug patients with events per 1000, relative risk comparing incidence in drug versus placebo patients, and risk difference for additional drug patients with events per 1000.*

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A data table titled 'TABLE 3. Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia.' It compares the percentage of adverse reactions reported for Gabapentin (N=336) and Placebo (N=227) across several body systems including Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses.*

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A table presenting adverse reactions in pooled placebo-controlled add-on trials in epilepsy patients over 12 years of age comparing gabapentin (N=543) and placebo (N=378). The table categorizes side effects by system (Body, Cardiovascular, Digestive, Nervous, Respiratory, Skin, Urogenital, Special Senses) with respective percentages for each treatment group.*

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Table 5 shows adverse reactions in a placebo-controlled add-on trial in pediatric epilepsy patients aged 3 to 12 years, comparing percentages of various side effects for Gabapentin (N=119) and Placebo (N=128) groups. Categories include body as a whole, digestive system, nervous system, and respiratory system symptoms.*

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Chemical structure of gabapentin showing its molecular framework with a cyclohexane ring, an amino group, and a carboxyl group.*

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A table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing study duration, gabapentin target doses in mg/day, and the count of patients receiving gabapentin or placebo across two studies. Study 1 lasted 8 weeks with a 3600 mg/day dose and involved 113 gabapentin and 116 placebo patients. Study 2 lasted 7 weeks with doses 1800 and 2400 mg/day, including 223 gabapentin and 111 placebo patients, totaling 336 gabapentin and 227 placebo participants.*

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A line graph comparing mean pain scores over eight weeks for placebo versus Gabapentin 3600 mg/day. The x-axis represents weeks from baseline to week 8, with a 4-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 10. Gabapentin shows a decreasing pain score trend, while placebo remains relatively stable.*

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A line graph depicting mean pain score over a 7-week period comparing placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day. The timeline includes a 3-week dose titration period followed by a 4-week fixed-dose period. Scores decrease more for Gabapentin doses compared to placebo.*

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A bar graph titled 'Proportion of Responders (patients with ≥ 50% reduction in pain score) at Endpoint: Controlled PHN Studies.' It compares percentages of responders for placebo (PBO) and different doses of Gabapentin (GBP 3600 in Study 1; GBP 1800 and GBP 2400 in Study 2). The graph shows higher response rates for Gabapentin doses compared to placebo, with statistical significance indicated for differences (p < 0.01 and p < 0.001).*

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A scatter plot comparing percentage differences against daily dose (mg) for Gabapentin across three studies labeled 'a,' 'b,' and 'c.' The x-axis shows daily doses of 600, 900, 1200, and 1800 mg, and the y-axis shows difference percentages from 2% to 22%. Study markers are indicated with different symbols and colors for distinction.*

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GABAPENTIN 100 MG capsules, bottle of 30, labeled by Unit Dose Services. The label shows the drug name and strength, manufacturer Invagen Pharm Inc. in Hauppauge, NY, and packaging information. It includes storage instructions and cautions to keep out of reach of children.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.