What is the recommended dose of Lyrica (pregabalin) for a patient with impaired renal function undergoing dialysis?

Pregabalin Dosing in Dialysis Patients

For patients on hemodialysis, start pregabalin at 25 mg once daily or every other day, with a supplemental dose of 25-100 mg immediately after each 4-hour dialysis session, and titrate slowly based on tolerability up to a maximum of 75 mg daily plus supplemental post-dialysis doses. 1

Initial Dosing Strategy

• Start at 25 mg once daily for hemodialysis patients, as this represents the lowest end of the dosing range for patients with severe renal impairment (creatinine clearance <15 mL/min) 1
• The FDA label specifies that for patients with creatinine clearance <15 mL/min, the total daily dose should range from 25-75 mg/day, administered as a single daily dose 1
• For smaller patients (e.g., <60 kg), starting at the absolute lowest dose (25 mg daily or even every other day) is particularly important to minimize adverse effects 2

Supplemental Post-Dialysis Dosing

Administer a supplemental dose immediately following every 4-hour hemodialysis treatment to replace drug removed during dialysis 1:

• If daily dose is 25 mg: give 25 mg or 50 mg supplemental dose post-dialysis
• If daily dose is 50-75 mg: give 50 mg or 75 mg supplemental dose post-dialysis
• If daily dose is 75 mg: give 75 mg or 100 mg supplemental dose post-dialysis 1

The timing is critical—always give medications after dialysis to prevent premature drug removal and facilitate directly observed therapy 3

Titration and Maximum Dosing

• Titrate slowly over weeks, not days, monitoring closely for adverse effects including drowsiness, dizziness, and encephalopathy 4
• The maximum recommended total daily dose for hemodialysis patients is 75 mg/day (given as a single dose), plus the supplemental post-dialysis dose 1
• In clinical studies of hemodialysis patients with neuropathic pain, the mean effective dose was approximately 50 mg daily, with doses ranging from 25-150 mg 4
• However, the FDA-approved maximum for patients with creatinine clearance <15 mL/min is 75 mg/day as the baseline dose 1

Critical Safety Considerations

Pregabalin carries significant risk of neurotoxicity in dialysis patients, even at therapeutic plasma concentrations 5:

• Myoclonic encephalopathy can occur without drug accumulation in patients with acute or chronic renal failure 5
• Common adverse effects in hemodialysis patients include drowsiness, dizziness, and somnolence, which may necessitate dose reduction or discontinuation 6, 4
• In one study, 10 of 45 hemodialysis patients (22%) withdrew due to adverse effects, primarily drowsiness and dizziness 4
• Start low and go slow—the risk of adverse effects is dose-dependent 1

Practical Implementation Algorithm

1. Baseline assessment: Document indication (neuropathic pain, uremic pruritus, etc.), weight, dialysis schedule, and baseline neurological status
2. Initial prescription: 25 mg once daily, taken after dialysis on dialysis days 1, 3
3. Week 1-2: Assess tolerability; if well-tolerated and inadequate response, may continue at 25 mg daily
4. Week 3-4: If needed, increase to 25 mg daily plus 25 mg post-dialysis supplemental dose (or increase baseline to 50 mg daily) 1
5. Week 5-8: If further titration needed and well-tolerated, increase to maximum of 75 mg daily plus appropriate supplemental post-dialysis dose 1
6. Ongoing monitoring: Assess for drowsiness, dizziness, confusion, or myoclonus at each dialysis session 5, 4

Key Pitfalls to Avoid

• Never exceed 75 mg/day as the baseline daily dose in hemodialysis patients, regardless of indication 1
• Do not forget the supplemental post-dialysis dose—pregabalin is removed by hemodialysis and requires replacement 1
• Avoid rapid titration—studies show better tolerability with gradual dose increases over weeks 4
• Do not assume therapeutic drug levels are safe—neurotoxicity can occur even with normal plasma concentrations in renal failure 5
• Monitor for encephalopathy and myoclonus, which may require immediate drug discontinuation 5