What is the maximum recommended dose of Lyrica (pregabalin)?

Maximum Dose of Lyrica (Pregabalin)

The maximum recommended dose of pregabalin is 600 mg per day, divided into two or three doses (300 mg twice daily or 200 mg three times daily). 1

FDA-Approved Maximum Dosing

• The FDA label explicitly states that 600 mg/day is the maximum dose across all approved indications, including neuropathic pain, postherpetic neuralgia, fibromyalgia, and partial-onset seizures 1
• This maximum applies to adults with normal renal function (creatinine clearance ≥60 mL/min) 1

Critical Clinical Context: When 600 mg/Day Should Be Used

The 600 mg/day dose should be reserved ONLY for patients who have inadequate pain relief after 2-4 weeks at 300 mg/day AND who tolerate the medication well. 2, 1

• The standard effective dose for most neuropathic pain conditions is 300 mg/day (150 mg twice daily or 100 mg three times daily) 2, 1
• Evidence shows that 300 mg/day provides the optimal benefit-to-risk ratio for most patients 2
• Doses above 300 mg/day are not consistently more effective but are associated with significantly greater adverse effects and higher treatment discontinuation rates 2, 1

Condition-Specific Maximum Dosing

• Diabetic peripheral neuropathy: Maximum 300 mg/day (100 mg three times daily) - the FDA label specifically states there is no evidence that 600 mg/day confers additional significant benefit for this condition 1
• Postherpetic neuralgia: Up to 600 mg/day may be used, but only after inadequate response to 300 mg/day for 2-4 weeks 2, 1
• Fibromyalgia: Maximum 450 mg/day recommended, though FDA label allows up to 600 mg/day 2, 1
• Partial-onset seizures: Maximum 600 mg/day in adults 1

Mandatory Dose Reductions

Renal impairment requires mandatory dose reduction, as pregabalin is eliminated 95-98% unchanged by the kidneys: 2, 3

• CrCl 30-60 mL/min: Reduce total daily dose by approximately 50%
• CrCl 15-30 mL/min: Reduce total daily dose by approximately 75%
• CrCl <15 mL/min: Reduce total daily dose by 85-90%

Elderly Patients

• Lower starting doses and slower titration are strongly recommended due to increased risk of dizziness, somnolence, confusion, balance disorders, and falls 2
• The maximum dose may need to be lower than 600 mg/day depending on tolerability 2

Critical Safety Warning About Maximum Dosing

• At 600 mg/day, dizziness occurs in 27-46% of patients and somnolence in 15-25% 2, 3
• Treatment discontinuation due to adverse events occurs in 18-28% at maximum doses 4
• The FDA label emphasizes that doses above 300 mg/day carry dose-dependent adverse reactions and should not be routinely prescribed 1

Common Pitfall to Avoid

Do not prescribe 600 mg/day as a standard starting or target dose. The evidence clearly demonstrates that most patients achieve optimal benefit at 300 mg/day, and escalation to 600 mg/day should only occur after documented inadequate response at the lower dose with good tolerability 2, 1

Discontinuation Protocol

• When stopping pregabalin at any dose, taper gradually over a minimum of 1 week to avoid withdrawal symptoms 2, 1