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

Maximum Recommended Dose of Lyrica (Pregabalin)

The maximum recommended dose of Lyrica (pregabalin) is 600 mg per day, divided into two or three doses, with no additional benefit typically observed above this dosage. 1, 2

FDA-Approved Maximum Dosages by Indication

• Neuropathic Pain Associated with Diabetic Peripheral Neuropathy:

  • Maximum recommended dose: 300 mg/day (100 mg three times daily) 2
  • Higher doses are not recommended due to lack of additional benefit and increased adverse effects 2

• Postherpetic Neuralgia:

  • Maximum recommended dose: 600 mg/day 2
  • Can be administered as 300 mg twice daily or 200 mg three times daily 2
  • Doses above 300 mg/day should be reserved only for patients with ongoing pain who tolerate 300 mg/day 2

• Adjunctive Therapy for Partial-Onset Seizures:

  • Maximum recommended dose: 600 mg/day 2
  • For adults and pediatric patients weighing ≥30 kg 2

• Fibromyalgia:

  • Maximum recommended dose: 450 mg/day 2
  • Typically administered as 225 mg twice daily 2

Dosing Considerations and Titration

• Start with lower doses (typically 50-75 mg twice daily or 50 mg three times daily) and titrate gradually based on efficacy and tolerability 1
• For neuropathic pain, initiate at 150 mg/day in divided doses, then increase to 300 mg/day after 3-7 days, with further increases as needed 1
• Pregabalin should be titrated gradually to minimize side effects, with incremental increases at intervals allowing for monitoring of effects 1
• An adequate trial for pain management may require up to 4 weeks to determine full efficacy 1

Special Population Considerations

• Renal Impairment: Dose adjustment required as pregabalin is eliminated primarily by renal excretion (98%) 2, 3
• Elderly Patients: Lower starting doses and slower titration recommended due to potential decreased renal function and increased sensitivity to side effects 1

Safety and Adverse Effects

• Most common adverse effects are dose-dependent and include:
  • Dizziness (23.1%) 3
  • Somnolence/drowsiness (14.6%) 3
  • Peripheral edema (10.4%) 3
• At 600 mg/day, somnolence typically occurs in 15-25% of patients and dizziness in 27-46% 4
• Treatment discontinuation due to adverse events occurs in approximately 18-28% of patients on higher doses 4
• Pregabalin is classified as a Schedule V controlled substance due to potential for abuse and dependence 5

Important Administration Notes

• Pregabalin can be taken with or without food 2
• When discontinuing, taper gradually over a minimum of 1 week to minimize withdrawal symptoms 2
• The effect of dose escalation rate on tolerability has not been formally studied 2

Caution

• Although pregabalin has been studied at doses higher than 600 mg/day, there is no evidence of additional benefit, and these higher doses are associated with more adverse effects 2, 6
• Use above recommended dosages is rare but may occur in susceptible patients, particularly males and those taking antipsychotics or benzodiazepines 6