What is the FDA-approved dose of Gabapentin (Gabapentin) for a patient with impaired renal function, specifically a creatinine clearance rate (CRCL) of 59?

From the Guidelines

For a patient with a creatinine clearance (CrCl) of 59 mL/min, the FDA-approved gabapentin dosing should be adjusted to 600-1800 mg daily in divided doses, with a recommended starting dose of 300 mg once daily and gradual titration upward based on the patient's response and tolerability 1. To determine the appropriate dose, it's essential to consider the patient's renal function, as gabapentin is primarily eliminated unchanged through the kidneys. With a CrCl of 59 mL/min, which falls in the mild renal impairment range (50-79 mL/min), the medication will be cleared more slowly from the body.

• Key considerations for dosing adjustments include:
  • Starting at a lower dose to minimize the risk of adverse effects
  • Gradually titrating upward every 3-7 days to reach an effective dose within the recommended range
  • Monitoring for side effects such as dizziness, somnolence, and peripheral edema, which may be more pronounced in patients with reduced renal function
  • Regularly assessing renal function during treatment to ensure the dose remains appropriate for the patient's changing renal function. Given the information provided in the study 1, it's crucial to prioritize the patient's renal function when determining the optimal gabapentin dose, ensuring that the benefits of treatment are balanced with the potential risks of adverse effects.
• The study 1 provides guidance on the pharmacological management of neuropathic pain, including recommendations for gabapentin dosing, which can be applied to patients with mild renal impairment. However, it's essential to note that the study 1 does not provide specific dosing recommendations for patients with CrCl of 59 mL/min, but the general principles of dose adjustment for renal impairment can be applied to guide clinical decision-making.

From the FDA Drug Label

TABLE 1 Gabapentin Tablets Dosage Based on Renal Function Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen (mg)

30-59 400-1400 200 BID 300 BID 400 BID 500 BID 700 BID

The FDA approved dose of gabapentin for a patient with a creatinine clearance (CrCL) of 59 is within the range of 400-1400 mg/day, with a dose regimen of 200-700 mg twice a day 2.

From the Research

FDA Approved Dose of Gabapentin for CrCL of 59

• The FDA approved dose of gabapentin for a creatinine clearance (CrCL) of 59 is not explicitly stated in the provided studies.
• However, according to the study 3, pregabalin dosage adjustment should be considered for patients with CrCL < 60 mL/min, and a 50% reduction in pregabalin daily dose is recommended for patients with CrCL between 30 and 60 mL/min.
• Although this study is about pregabalin, not gabapentin, it provides some insight into the dosage adjustment for patients with decreased renal function.
• The study 4 suggests that dosage adjustment for gabapentin enacarbil is necessary in patients with impaired renal function, but it does not provide a specific dosage recommendation for a CrCL of 59.
• The study 5 found that patients with a CrCL < 60 mL/min were frequently prescribed inappropriately high doses of gabapentinoids, but it does not provide a specific dosage recommendation for a CrCL of 59.
• The studies 6 and 7 do not provide specific dosage recommendations for gabapentin for a CrCL of 59, but they highlight the importance of judicious use of gabapentin and pregabalin in patients with decreased renal function.

Dosage Adjustment for Gabapentin

• Based on the study 3, it can be inferred that a dosage adjustment for gabapentin may be necessary for patients with a CrCL of 59, but the exact dosage reduction is not specified.
• The study 4 suggests that the pharmacokinetics of gabapentin derived from gabapentin enacarbil are affected by renal function, and dosage adjustment may be necessary in patients with impaired renal function.
• However, without explicit FDA guidance or further studies, it is difficult to determine the exact dosage adjustment for gabapentin for a CrCL of 59.