Maximum Dose of Pregabalin
The maximum recommended dose of pregabalin is 600 mg per day, administered in two or three divided doses. 1
Standard Dosing Framework
The FDA-approved maximum of 600 mg/day applies across all indications, though the therapeutic target varies by condition 1:
- Diabetic peripheral neuropathy: Maximum 300 mg/day (100 mg three times daily) - doses above this are not recommended as 600 mg/day showed no additional benefit and was less well tolerated 1
- Postherpetic neuralgia: 150-300 mg/day is standard; 600 mg/day is reserved only for patients with ongoing pain who tolerate 300 mg/day but have insufficient relief after 2-4 weeks 1
- Partial-onset seizures (adults): Up to 600 mg/day in 2-3 divided doses 1
- Fibromyalgia: 300-450 mg/day is recommended; 600 mg/day showed no additional benefit and was less well tolerated 1
Dosing Administration
Pregabalin should be administered in 2 or 3 divided doses per day (e.g., 300 mg twice daily or 200 mg three times daily for the 600 mg maximum) 1. The medication can be taken with or without food 1.
Critical Dose-Dependent Considerations
Higher doses above 300 mg/day often provide minimal additional benefit while substantially increasing adverse effects 2, 1. The dose-dependent adverse reactions include:
- Dizziness (23-46% at higher doses) 2
- Somnolence (15-25%) 2
- Peripheral edema (10%) 2
- Higher discontinuation rates due to adverse events (18-28% at 600 mg/day) 3
Mandatory Dose Adjustments
Renal impairment requires dose reduction since pregabalin is eliminated primarily unchanged by the kidneys 4, 2, 1:
- CrCl 30-60 mL/min: Reduce total daily dose by approximately 50% 2
- CrCl 15-30 mL/min: Reduce by 75% 2
- CrCl <15 mL/min: Reduce by 85-90% 2
Special Population Warnings
Elderly patients require lower starting doses and slower titration due to increased risk of dizziness, somnolence, confusion, balance disorders, and falls 4, 2. Start at the lowest dose and escalate gradually over longer intervals than in younger adults 4.
Discontinuation Protocol
When stopping pregabalin, taper gradually over a minimum of 1 week to avoid withdrawal symptoms 2, 1. Abrupt discontinuation should be avoided 2.
Common Pitfall
The most frequent error is escalating to 600 mg/day routinely rather than reserving it for specific scenarios. For most conditions, 300 mg/day is the optimal therapeutic dose - further increases to 600 mg/day should only occur in patients who: (1) have ongoing pain despite 2-4 weeks at 300 mg/day, (2) tolerate the current dose well, and (3) have conditions where higher doses may provide benefit (postherpetic neuralgia, seizures) 2, 1.