Gabapentin Tablet
Product Images NDC 68071-3445

This text appears to be the description of a medication called Gabapentin. It is in tablet form and each tablet contains 600 mg of gabapentin. The medication is intended to be dispensed by a pharmacist and comes with a Medication Guide for patients. It should be stored at a temperature between 15°C to 30°C (59°F to 86°F). The medication should be dispensed in tight, child-resistant containers. For detailed prescribing information, it is recommended to refer to the package insert. The medication is manufactured by Ascent Pharmaceuticals, Inc. and distributed by Camber Pharmaceuticals, Inc.*

This text appears to be a list of symptoms commonly associated with a medical condition or illness. These symptoms include lack of coordination, viral infection, difficulty with speaking, tremor, swelling (usually of the legs and feet), feeling tired, fever, feeling drowsy, nausea and vomiting, jerky movements, difficulty with coordination, double vision, and unusual eye movement. Based on these symptoms, it is possible that the individual may be experiencing a neurological or viral illness. Further medical evaluation is recommended to determine the exact cause and provide appropriate treatment.*

TABLE 1. Gabapentin Dosage Based on Renal Function This table provides dosing guidelines for the medication Gabapentin based on the patient's renal function. The dosage is determined by the patient's creatinine clearance, which is a measure of kidney function. The table includes different dosage regimens for different ranges of creatinine clearance. For patients with a creatinine clearance of 60 mL/min or higher, the total daily dose ranges from 900 mg to 3600 mg, to be taken three times a day (TID). For patients with a creatinine clearance of 30 to 59 mL/min, the total daily dose ranges from 400 mg to 1400 mg, to be taken twice a day (BID). For patients with a creatinine clearance of 15 to 29 mL/min, the total daily dose ranges from 200 mg to 700 mg, to be taken once a day (QD). For patients with a creatinine clearance of 15 mL/min or lower, the daily dose should be reduced in proportion to the creatinine clearance. The table also provides supplemental doses for patients on hemodialysis. These doses should be administered after each 4 hours of hemodialysis, with the dosage determined based on estimates of creatinine clearance. Please note that TID refers to three times a day, BID refers to two times a day, and QD refers to a single daily dose. It is important to consult a healthcare professional for personalized dosing instructions, especially for patients with low creatinine clearance or undergoing hemodialysis.*

TABLE 3. Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia This table provides data on the adverse reactions reported in pooled placebo-controlled trials for postherpetic neuralgia. The trials involved the use of Gabapentin compared to a placebo. The table presents the number of patients (N) in each group and the percentage (%) of patients experiencing each adverse reaction. The adverse reactions are categorized into different body systems, including: - Body as a Whole: Asthenia (6% in Gabapentin group, 5% in placebo group), Infection (5% in Gabapentin group, 4% in placebo group), Accidental injury (3% in Gabapentin group, 1% in placebo group) - Digestive System: Diarrhea (6% in Gabapentin group, 3% in placebo group), Dry mouth (5% in Gabapentin group, 1% in placebo group), Constipation (4% in Gabapentin group, 2% in placebo group), Nausea (4% in Gabapentin group, 3% in placebo group), Vomiting (3% in Gabapentin group, 2% in placebo group) - Metabolic and Nut: Peripheral edema (8% in Gabapentin group, 2% in placebo group), Weight gain (2% in Gabapentin group, 0% in placebo group), Hyperglycemia (1% in Gabapentin group, 0% in placebo group) - Nervous System: Dizziness (28% in Gabapentin group, 8% in placebo group), somnolence (21% in Gabapentin group, 5% in placebo group), Ataxia (3% in Gabapentin group, 0% in placebo group), Abnormal thinking (3% in Gabapentin group, 0% in placebo group), Abnormal gait (2% in Gabapentin group, 0% in placebo group), Incoordination (2% in Gabapentin group, 0% in placebo group) - Respiratory System: Pharyngitis (1% in Gabapentin group, 0% in placebo group) - Special Senses: Amblyopia (3% in Gabapentin group, 1% in placebo group), Conjunctivitis (1% in Gabapentin group, 0% in placebo group), Diplopia (1% in Gabapentin group, 0% in placebo group), Otitis media (1% in Gabapentin group, 0% in placebo group) Blurred vision was also reported.*

TABLE 4 shows the adverse reactions reported in pooled placebo-controlled add-on trials in epilepsy patients aged 12 years and above. The table provides the number of occurrences and percentages for each adverse reaction for both the Gabapentin® group and the Placebo group. Some of the adverse reactions reported include fatigue, increased weight, back pain, peripheral edema, dyspepsia, dry mouth or throat, constipation, somnolence, dizziness, ataxia, nystagmus, tremor, dysarthria, amnesia, depression, abnormal thinking, abnormal coordination, pharyngitis, coughing, abrasion, impotence, diplopia, and amblyopia. Amblyopia is described as blurred vision.*

This text provides a summary of adverse reactions observed in a placebo-controlled add-on trial involving pediatric epilepsy patients aged 3 to 12 years. The table includes data for Gabapentin® and Placebo® groups, with the number of participants (N) indicated for each group. The adverse reactions mentioned in the text include Nausea and/or Vomiting, Emotional Lability, and Respiratory Infection. However, there is some unclear text at the end. Nevertheless, the information available suggests that this trial evaluated the adverse reactions associated with the use of Gabapentin® in pediatric epilepsy patients.*

This text provides information on controlled studies conducted on patients with PHN (postherpetic neuralgia) and their treatment with gabapentin. The table includes details such as the duration of the studies, dosages administered, and the number of patients involved. The first study lasted 8 weeks and involved a target dose of 3600 mg/day of gabapentin, with 113 patients receiving the medication and 116 receiving a placebo. The second study lasted 7 weeks and involved dosages of 1800 and 2400 mg/day of gabapentin, with 223 patients receiving the medication and 111 receiving a placebo. In total, there were 336 patients who received gabapentin and 221 who received a placebo. The medication was given in three divided doses per day.*

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