Gabapentin Capsule
Product Images NDC 60760-669

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 60760-669). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by St. Mary's Medical Park Pharmacy, 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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Equation (Equ)

This text provides formulas for calculating estimated creatinine clearance based on age, weight, and serum creatinine level. The first formula calculates using age and weight, while the second formula uses serum creatinine level. There is also an adjustment for female patients in the second formula.*

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Fig 1 (Fig 1)

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Fig 2 (Fig 2)

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Fig 3 (Fig 3)

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Fig 4 (Fig 4)

This text presents a figure illustrating the Responder Rate in patients receiving Gabapentin as compared to Placebo in Adjunctive Therapy Studies for patients over 12 years old with Partial Seizures. The figure shows the difference from Placebo based on Gabapentin dose and study.*

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60760-669 (Gabapentin 100mg 60760 669 90)

This text appears to be details of a medication packaging for Gabapentin capsules. The capsules are in 100mg strength with a quantity of 60 capsules in each pack. The manufacturer is mentioned as HERO, located in Karnataka, India. The medication is to be used as directed and should be stored at controlled room temperature. The expiration date and lot numbers are provided for reference. Additionally, there are details about prescription numbers and how the medication is packaged.*

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Structure (Struct)

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Table 1 (Tab 1)

This is a dosage table for Gabapentin based on renal function. The table provides dosages depending on the patient's creatinine clearance levels. It includes dosage regimens for patients with different levels of renal function, as well as supplemental doses for patients on hemodialysis. The table also explains the abbreviations used, such as TID for three times a day, BID for two times a day, and QD for a single daily dose. Additionally, it outlines dosage adjustments for patients with lower creatinine clearance levels.*

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Table 2 (Tab 2)

This is a table providing information on the risk factors associated with antiepileptic drugs based on different indications. The table presents data on the number of events per 1,000 patients for each indication (epilepsy, psychiatric, and other) in both placebo and drug patients. It also includes the relative risk incidence by calculating the ratio of events in drug patients to events in placebo patients for each indication. Additionally, the risk difference is provided, showing the additional number of drug patients with events per 1,000 patients compared to placebo patients.*

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Table 3 (Tab 3)

This section provides a breakdown of adverse reactions from pooled placebo-controlled trials in postherpetic neuralgia for Gabapentin and Placebo. Common side effects include asthenia, infection, accidental injury, diarrhea, dry mouth, constipation, nausea, vomiting, peripheral edema, weight gain, hyperglycemia, dizziness, somnolence, ataxia, abnormal thinking, abnormal gait, incoordination, pharyngitis, amblyopia, conjunctivitis, diplopia, and otitis media. Blurred vision was also reported.*

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Table 4 (Tab 4)

This is a table showing adverse reactions in pooled placebo-controlled add-on trials in epilepsy patients over 12 years of age. Gabapentin and placebo were compared, with the percentage of patients experiencing each adverse reaction listed. Adverse reactions include fatigue, increased weight, back pain, peripheral edema, cardiovascular issues, digestive system problems, nervous system effects, respiratory problems, skin issues, urogenital system effects, and special senses issues. The table also mentions that amblyopia was often described as blurred vision.*

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Table 5 (Tab 5)

This is a table displaying adverse reactions reported in a placebo-controlled add-on trial for pediatric epilepsy patients aged 3 to 12 years using Gabapentin. Some of the common adverse reactions included viral infection, fever, increased weight, fatigue, nausea and/or vomiting, somnolence, hostility, emotional lability, dizziness, hyperkinesia, bronchitis, and respiratory infection. These adverse reactions were observed alongside the patients receiving background antiepileptic drug therapy.*

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Tab 6 (Tab 6)

This text provides details of controlled postherpetic neuralgia (PHN) studies involving the use of gabapentin. It includes the duration of the studies, dosages administered, and the number of patients involved in each study. The target doses of gabapentin and placebo are specified for each study. The patients were given gabapentin in three divided doses per day (TID).*

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