Gabapentin
Product Images NDC 10544-557

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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 10544-557). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Blenheim Pharmacal, 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

7d5ebe51-figure-06 (Label Gabapentin Caps 400mg Bpi(10544 557 90) Camber(31722 223 05) Rev2)

7d5ebe51-figure-06 (Label Gabapentin Caps 400mg  Bpi(10544 557 90) Camber(31722 223 05) Rev2)
Gabapentin Capsules, USP 400mg is a prescription drug available in packs containing 90 capsules. Each capsule consists of Gabapentin, classified under the category of anticonvulsants. The dosage instructions are mentioned in the package insert. Ensure the capsules are stored in a tightly sealed container and kept in a safe place away from children. The batch number and expiry date are mentioned on the package. The drug must be stored at a controlled room temperature (20°-25°C or 68-77°F).*
FDA Label Image

Fig1-2-3 (Fig123)

Fig1-2-3 (Fig123)
The description is about a comparison of pain scores in two studies using different medications. The first study used "L & abspenti" at a dose of 3600 madsy, while the second study compared two doses of "Gabaparin". Weekly mean pain scores were calculated and presented in Figure 1 for study 1 and Figure 2 for study 2. The proportion of responders, defined as patients reporting a 50% or greater improvement in endpoint pain score compared with baseline, was also calculated and presented in Figure 3.*
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Fig4 (Fig4)

Fig4 (Fig4)
Not available.*
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Table1 (Img1)

Table1 (Img1)
This is a dosage table for gabapentin based on renal function. The recommended dose varies depending on the patient's glomerular filtration rate, which is displayed in mL/min. The dosage also varies depending on whether the patient is on hemodialysis. The recommended dose ranges from 100mg to 1200mg per day, divided into either a single dose or multiple doses. For patients with creatinine clearance less than 15 mL/min, the daily dose should be reduced in proportion to creatinine clearance. The Cockcroft and Gault equation is a reasonable estimation for calculating creatinine clearance when it cannot be measured. The use of gabapentin in patients under 12 with compromised renal function has not been studied.*
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Structure (Struct)

FDA Label Image

Table-2 (Tab2)

Table-2 (Tab2)
This appears to be a table containing information on the risk of antiepileptic drugs for different indications. The indications listed are epilepsy, psychiatric, and other. The table shows the number of patients with events per 1000 patients for both placebo and drug patients, as well as the relative risk and risk difference. However, without additional context or clearer formatting, it is difficult to draw any specific conclusions from this information.*
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Tab3 (Tab3)

Tab3 (Tab3)
This is a table that shows the adverse reactions observed in different systems of the body in pooled placebo-controlled trials in Postherpetic Neuralgia treated with Gabapentin and placebo. The symptoms observed in Gabapentin include Asthenia, Infection, Accidental injury, Diarrhea, Dry mouth, Constipation, Hausea, Vomiting, Peripheral edema, Weight gain, Hyperglycemia, Dizziness, Somnolence, Aavia, Abnormal thinking, Abnormal gait, Incoordination, Amblyopia, Conjunctivitis, Diplopia, Otitis media and blurred vision.*
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Tab4 (Tab4)

Tab4 (Tab4)
This is a useful description of the adverse reactions observed in epilepsy patients aged 12 years and above, who received Gabapentin as add-on therapy. The data in TABLE 4 shows a list of adverse reactions reported in the patients who received Gabapentin. The reactions are categorized under different systems like body as a whole, cardiovascular, digestive system, nervous system, respiratory system, skin and appendages, urogenital system, and special senses. Some of the commonly reported adverse reactions include fatigue, increased weight, back pain, dyspepsia, somnolence, dizziness, tremor, pharyngitis, and impotence. A unique adverse reaction is Amblyopia, which is described as blurred vision. It is important to note that this data is obtained through pooled placebo-controlled trials and the patients included in these trials were already receiving background antiepileptic drug therapy.*
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Tab5 (Tab5)

Tab5 (Tab5)
This is a table showing adverse reactions in a placebo-controlled trial of Gabapentin in pediatric epilepsy patients aged between 3 and 12 years. The table compares the percentage of adverse reactions in patients who received Gabapentin with those who received a placebo. Adverse reactions observed in patients receiving Gabapentin were Viral Infection, Fever, Increased Weight, Fatigue, Nausea and/or Vomiting, Somnolence, Hostility, Emotional Lability, Dizziness, Hyperkinesia, Bronchitis, and Respiratory Infection. The patients also received background antiepileptic drug therapy.*
FDA Label Image

Table-6 (Tab6)

Table-6 (Tab6)
The text provides a table showing details of controlled PHN studies, including the duration of each study, dosages administered, and the number of patients receiving Gabapentin and Placebo. Study 1 lasted for 8 weeks and administered 3600mg/day of Gabapentin to 113 patients and placebo to 116 patients. Study 2 lasted for 7 weeks and administered 1800 and 2400mg/day of Gabapentin in 3 divided doses to 223 patients and placebo to 111 patients. The total number of patients who received Gabapentin or Placebo was 336 and 227, respectively.*

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