From the FDA Drug Label
Because pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function [see DOSAGE AND ADMINISTRATION (2.7)]. The maximum recommended dose of pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min.
Dose adjustment is required for patients with impaired renal function. The dose should be adjusted based on the patient's creatinine clearance. 1
From the Research
Pregabalin requires dose adjustment in patients with impaired renal function to prevent potential adverse effects and ensure optimal therapeutic outcomes. The standard dosing of pregabalin should be reduced based on creatinine clearance (CrCl) levels. For patients with CrCl ≥60 mL/min, no adjustment is needed. For CrCl 30-60 mL/min, the daily dose should be reduced by 50%. When CrCl is 15-30 mL/min, the dose should be decreased by 75%. For CrCl <15 mL/min, the daily dose should be reduced by 87.5%. Patients on hemodialysis should receive a supplemental dose immediately after each dialysis session. These adjustments are necessary because pregabalin is primarily eliminated unchanged through renal excretion, with approximately 90% of the drug excreted in urine 2. Without proper dose adjustment, the drug can accumulate in patients with kidney impairment, potentially leading to increased side effects such as dizziness, somnolence, peripheral edema, and weight gain. Regular monitoring of renal function is recommended when prescribing pregabalin to patients with kidney disease or those at risk of developing renal impairment.
Key considerations for dose adjustment include:
- CrCl levels: dose reduction is necessary for patients with CrCl <60 mL/min
- Hemodialysis: supplemental doses are required after each dialysis session
- Renal function monitoring: regular monitoring is essential to adjust doses accordingly
- Potential adverse effects: dose adjustment can help prevent increased side effects in patients with kidney impairment
It is essential to note that pregabalin's pharmacokinetics are highly predictable and linear, making it easy to use in clinical practice 3. However, the drug's elimination is heavily dependent on renal function, emphasizing the need for dose adjustment in patients with impaired renal function. Studies have demonstrated the importance of proper dose adjustment to prevent adverse effects and ensure optimal therapeutic outcomes 4, 5. Additionally, electronic prescribing and automated reporting of estimated glomerular filtration rate (eGFR) can help reduce medication errors and improve patient safety 6.