Gabapentin
Product Images NDC 45865-498

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Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 45865-498). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medsource Pharmaceuticals, 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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Pdp (498 60)

Pdp (498 60)
This is a description for Gabapentin capsules with a strength of 400mg. The capsules are a generic alternative for Neurontin. Each capsule contains Gabapentin 400HG. The capsules come in a package size of 60. The manufacturer's name is Wer canber Pharmace. The National Drug Code is 45865-0498-60. The capsules may cause dizziness or drowsiness; therefore, it is recommended to avoid alcohol. The instructions say to take the capsules ten times a day.*
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Figure3 (Figure3)

Figure3 (Figure3)
The text describes a figure that shows the proportion of responders in each study who reported a minimum of 50% improvement in endpoint pain score compared to baseline. It is not possible to conclude anything else from this text.*
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Figure4 (Figure4)

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Structure (Structure)

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Study1 (Study1)

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Study2 (Study2)

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Table1 (Table1)

Table1 (Table1)
The text provides a table that shows the recommended dosage range for gabapentin depending on a patient's renal function, specifically their creatinine clearance rate. The table provides detailed dosing information for patients with creatinine clearance rates greater than 60 mL/min down to those who require hemodialysis. Patients with a clearance rate below 15 mL/min must have their dosage adjusted proportionally. The table concludes with information advising that gabapentin has not been studied in patients under the age of 12 with compromised renal function.*
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Table2 (Table2)

Table2 (Table2)
This text is a table showing the risk of antiepileptic drugs in comparison to placebos for different indications such as epilepsy, psychiatric conditions, and others. The table provides data on the number of patients with events per 1000 patients and the relative risk and risk difference. It is a useful resource for evaluating the risks associated with antiepileptic drugs for different indications.*
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Table3a (Table3a)

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Table3b (Table3b)

Table3b (Table3b)
This appears to be a list of symptoms, side effects or medical conditions. It mentions nervous system issues such as dizziness, somnolence, ataxia, and incoordination, respiratory problems like pharyngitis and sensory problems including amblyopias, conjunctivitis, and diplopia. It also includes the number "28" and "21" with unclear context, as well as a note on reported blurred vision. It is possible that this text describes side effects or symptoms experienced by a patient taking medication, but without additional context or information, it is difficult to determine the precise nature and cause of these issues.*
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Table4a (Table4a)

Table4a (Table4a)
In this document, we have a table that presents the incidence of treatment-emergent adverse reactions in controlled add-on trials with Gabapentin in patients over 12 years of age. The reactions listed in the table have occurred in at least 1% of Gabapentin patients and were numerically more frequent than in the placebo group. The table shows the rates of adverse reactions for both Gabapentin and Placebo groups in percentages for different body systems like Body as a Whole, Cardiovascular, and Digestive System. The adverse reactions include Fatigue, Weight Increase, Back Pain, Peripheral Edema, Vasodilation, Dyspepsia, Mouth or Throat Dry, Constipation, and Dental Abnormalities.*
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Table4b (Table4b)

Table4b (Table4b)
This text describes the side effects of a medication on different systems of the body. Specifically, it lists the frequency of occurrences of various symptoms related to the nervous system, respiratory system, urogenital system, and special senses. The medication is likely to be an antiepileptic drug and the last line provides a definition of amblyopia.*
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Table5 (Table5)

Table5 (Table5)
This is a table showing the incidence of treatment-emergent adverse reactions in pediatric patients aged 3 to 12 years who participated in a controlled add-on trial of Gabapentin. The listed adverse reactions occurred in at least 2% of Gabapentin patients and were numerically more frequent than in the placebo group. The table includes the body system affected, the adverse reaction, and the percentage of patients experiencing it in both the Gabapentin and placebo groups. Adverse reactions listed include viral infection, fever, weight increase, fatigue, nausea and/or vomiting, somnolence, hostility, emotional lability, dizziness, hyperkinesia, bronchitis, and respiratory infection. The study involved patients on background antiepileptic drug therapy.*
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Table6 (Table6)

Table6 (Table6)
This is a table showing the duration, dosages, and number of patients in two controlled studies on the use of Gabapentin for PHN treatment. Study 1 lasted for 8 weeks with a target dose of 3600mg/day and had 113 patients receiving Gabapentin and 116 receiving placebo. Study 2 lasted for 7 weeks with dosages of 1800 and 2400mg/day given in 3 divided doses per day (TID) and had 223 receiving Gabapentin and 111 receiving placebo. The total number of patients in both studies was 336 receiving Gabapentin and 227 receiving placebo.*

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