Gabapentin Tablet
Product Images NDC 58118-0166

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 58118-0166). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Clinical Solutions Wholesale, Llc, 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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Gabapentin 600mg Tablets 30ct Blister Card (600mg 100s)

This text provides details on Gabapentin 600mg tablets, including NDC, quantity, manufacturer information, lot number, batch number, expiration date, and location of the wholesaler, Clinical Solutions Wholesale, LLC. The medication is manufactured by Camber Pharmaceuticals and has an expiration date of April 2025.*

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Gabapentin 600mg Tablets 30ct Blister Card (800 mg 100s)

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Sideeffects (Sideeffects)

This text lists common symptoms of a neurological disorder. These symptoms include lack of coordination, tremors, difficulty with speaking, swelling in the legs and feet, fatigue, fever, drowsiness, nausea, vomiting, jerky movements, double vision, and unusual eye movements. This information can help in identifying potential health issues or seeking appropriate medical attention.*

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Table-1 (Table1)

This text provides a comprehensive table detailing the recommended Gabapentin dosage based on renal function, including specific total daily doses for different ranges of creatinine clearance levels. It also mentions adjustments for patients with low creatinine clearance and supplemental post-hemodialysis doses for those on hemodialysis. The table outlines dosing regimens for various levels of renal function, such as TID (three times a day), BID (two times a day), and QD (single daily dose). It serves as a helpful guide for healthcare professionals prescribing Gabapentin in patients with renal impairment.*

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Table-2 (Table2)

This text provides data on risks associated with antiepileptic drugs for different indications such as epilepsy, psychiatric conditions, and others. The table shows the incidence of events per 1,000 patients for both placebo and drug patients, along with relative risk and risk differences. The information helps in comparing the safety profile of antiepileptic drugs based on different indications.*

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Table-3 (Table3)

This is a table displaying the adverse reactions observed in pooled placebo-controlled trials for postherpetic neuralgia treatment with Gabapentin compared to placebo. The table lists various side effects categorized by body systems, including Body as a Whole, Digestive System, Metabolic and Nutritional, Nervous System, Respiratory System, and Special Senses. Adverse reactions such as asthenia, dizziness, diarrhea, and peripheral edema are reported with their respective frequencies in percentage for both the Gabapentin and Placebo groups.*

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Table-4 (Table4)

The text provides a list of adverse reactions observed in pooled placebo-controlled add-on trials in epilepsy patients aged 12 years and older who were treated with Gabapentin. Adverse reactions include fatigue, back pain, peripheral edema, cardiovascular symptoms, digestive issues like dyspepsia and constipation, nervous system effects like somnolence and dizziness, respiratory symptoms like pharyngitis, and other reactions such as impotence and blurred vision. The data also suggest the use of background antiepileptic drug therapy in these patients.*

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Table-5 (Table5)

This text provides a table showing the adverse reactions observed in a placebo-controlled add-on trial in pediatric epilepsy patients aged 3 to 12 years, comparing the effects of Gabapentin® versus Placebo®. Adverse reactions listed include Nausea and/or Vomiting, Emotional Lability, Respiratory Infection, and Phosphaturia, a side effect of an anti-epileptic drug.*

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Table-6 (Table6)

This text provides information on controlled Postherpetic Neuralgia (PHN) studies, including the duration, dosages, and number of patients involved. The two studies listed show different durations, dosages, and the number of patients receiving Gabapentin and Placebo. Study 1 had a duration of 8 weeks with a target dose of 3600 mg/day, while Study 2 lasted 7 weeks with target doses of 1800 mg/day and 2400 mg/day, respectively. The total number of patients involved in both studies was 336 for Gabapentin and 221 for Placebo. Additionally, Gabapentin was administered in three divided doses per day (TID) in Study 2.*

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Clcr (Clcr)

This text seems to describe a formula or calculation involving age, weight, gender, and serum creatinine levels. The formula appears to be related to a medical or health assessment.*

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Figure-1 (Figure1)

This text provides a chart showing the weekly mean pain scores for observed cases in the ITT population in Study 1. Gabapentin at a dose of 3500 iy is being compared in this study. The chart displays how the mean pain score changes over time, from baseline to weeks 1 to 8.*

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Figure-2 (Figure2)

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Figure-3 (Figure3)

This text provides information on the proportion of responders (patients with greater than 50% reduction in pain score) at the endpoint of controlled post-herpetic neuralgia (PHN) studies. Study 1 and Study 2 are mentioned along with different treatment groups such as PBO, GBP 1800, and GBP 2400.*

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Figure-4 (Figure4)

The text provides information on the responder rate in patients receiving gabapentin compared to placebo, based on dose and study in adjunctive therapy studies with patients over 12 years old with partial seizures. The data includes percentage differences, daily doses in milligrams, and mentions three different studies: Study a, Study b, and Study c.*

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Struc (Struct)

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