Gabapentin
Product Images NDC 50436-7285

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Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 50436-7285). 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

Fig1-2-3 (Fig123)

Fig1-2-3 (Fig123)
The text describes the weekly mean pain scores observed in two studies (Study 1 and Study 2), with baseline and pain scores indicated in Figure 1 and Figure 2. The proportion of responders who reported at least 50% improvement in endpoint pain score compared to baseline was also calculated, with results presented in Figure 3. The studies involved the use of medications such as L & Gabaparii, Gabapartin, and Controlled PHN Studies.*
FDA Label Image

Fig4 (Fig4)

FDA Label Image

Table1 (Img1)

Table1 (Img1)
The text provides a dosage chart for Gabapentin based on renal function. The dosage varies based on the patient's renal function, with patients with lower renal function receiving a reduced dose. The chart shows the daily doses for patients with different levels of renal function, along with a post-hemodialysis supplemental dose for patients on hemodialysis. The text also includes information on how to estimate creatinine clearance and notes that the use of gabapentin in children with compromised renal function has not been studied.*
FDA Label Image

Label Image (Lbl504367285)

Label Image (Lbl504367285)
This text appears to be a product label for a drug called Gabapentin. It includes information such as the lot number, dosage amount (300mg), and packaging details (30 capsules in one package). Additionally, there is a manufacturer's NDC (National Drug Code) listed and an expiration date.*
FDA Label Image

Structure (Struct)

FDA Label Image

Table-2 (Tab2)

Table-2 (Tab2)
This is a table displaying the risk of antiepileptic drugs categorized by their indication. The indications evaluated are epilepsy, psychiatric conditions, and other conditions. The table presents the number of patients with events per 1000 patients for both placebo and drug groups, and shows the relative risk and risk difference between them for each indication.*
FDA Label Image

Tab3 (Tab3)

Tab3 (Tab3)
This is a table that shows the adverse reactions in pooled placebo-controlled trials in Postherpetic Neuralgia for Gabapentin and Placebo. The data shows the percentage of patients who reported specific adverse reactions. The adverse reactions are categorized by body system and include: Asthenia, Infection, Accidental injury, Diarrhea, Dry mouth, Constipation, Nausea, Vomiting, Peripheral edema, Weight gain, Hyperglycemia, Dizziness, Somnolence, Anxiety, Abnormal thinking, Abnormal gait, Incoordination, Pharyngitis, Amblyopia, Conjunctivitis, Diplopia and Otitis media. Blurred vision is listed under abnormal thinking.*
FDA Label Image

Tab4 (Tab4)

Tab4 (Tab4)
This is a report on the adverse reactions documented in pooled placebo-controlled add-on trials among epilepsy patients over the age of 12 who were prescribed Gabapentin. The report includes a breakdown of the percentage of patients who experienced adverse reactions relating to various bodily systems including body as a whole, cardiovascular, digestive system, nervous system, respiratory system, skin and appendages, urogenital system, and special senses. Some of the documented adverse reactions include fatigue, increased weight, dyspepsia, dry mouth or throat, somnolence, dizziness, tremor, depression, abnormal thinking, pharyngitis, coughing, impotence, and diplopia. Additionally, Amblyopia was often described as blurred vision.*
FDA Label Image

Tab5 (Tab5)

FDA Label Image

Table-6 (Tab6)

Table-6 (Tab6)
This text provides information about the dosages, duration, and number of patients in two controlled PHN studies conducted using Gabapentin. The table shows that the target dose and duration of the first study were 3600 mg/day and 8 weeks, respectively, and the number of patients receiving gabapentin and placebo were 113 and 116, respectively. Whereas, the target dose and duration of the second study were 1800-2400 mg/day and 7 weeks, respectively, and the number of patients receiving gabapentin and placebo were 223 and 111, respectively. The text also mentions that in the second study, gabapentin was given in 3 divided doses (TID).*

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