What is the dosing for Pregabalin (Lyrica)?

From the Guidelines

Lyrica (pregabalin) should be started at 50 mg 3 times a day, with gradual titration based on response and tolerability, up to a maximum dose of 600 mg daily in divided doses, as recommended by the most recent and highest quality study 1. The effective dose range is usually 150-600 mg daily, divided into two or three doses.

• For neuropathic pain, including diabetic peripheral neuropathy and postherpetic neuralgia, 300-600 mg daily is often needed.
• For fibromyalgia, 300-450 mg daily is typically effective.
• For generalized anxiety disorder, 150-600 mg daily is recommended. Patients with renal impairment require dose reduction based on creatinine clearance, as pregabalin is more efficiently absorbed through the GI tract than gabapentin, and dose adjustment is required for those with renal insufficiency 1. Elderly patients may need lower starting doses and slower titration, as they may be more susceptible to the side effects of the medication 1. Lyrica should be tapered gradually over at least one week when discontinuing to avoid withdrawal symptoms. The medication works by binding to voltage-gated calcium channels in the central nervous system, reducing the release of excitatory neurotransmitters. Common side effects include dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and concentration difficulties, which often improve with continued use. It is essential to monitor patients for these side effects and adjust the dose accordingly, to minimize the risk of adverse effects and maximize the therapeutic benefits of the medication 1.

From the FDA Drug Label

2.1 Important Administration Instructions Pregabalin is given orally with or without food. When discontinuing pregabalin, taper gradually over a minimum of 1 week [see WARNINGS AND PRECAUTIONS (5. 6)]. Because pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function [see DOSAGE AND ADMINISTRATION (2.7)]. 2. 2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults 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. 2. 3 Postherpetic Neuralgia in Adults The recommended dose of pregabalin is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. 2. 4 Adjunctive Therapy for Partial-Onset Seizures in Patients 1 Month of Age and Older The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. 2. 5 Management of Fibromyalgia in Adults The recommended dose of pregabalin for fibromyalgia is 300 to 450 mg/day. 2. 6 Neuropathic Pain Associated with Spinal Cord Injury in Adults The recommended dose range of pregabalin for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. 2. 7 Dosing for Adult Patients with Renal Impairment In view of dose-dependent adverse reactions and since pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function.

The dosing of Lyrica (pregabalin) varies by indication.

• Neuropathic Pain Associated with Diabetic Peripheral Neuropathy: 300 mg/day (100 mg three times a day)
• Postherpetic Neuralgia: 150 to 300 mg/day (75 to 150 mg two times a day, or 50 to 100 mg three times a day)
• Adjunctive Therapy for Partial-Onset Seizures: dosages are included in Table 1
• Management of Fibromyalgia: 300 to 450 mg/day
• Neuropathic Pain Associated with Spinal Cord Injury: 150 to 600 mg/day
• Adult Patients with Renal Impairment: adjust the dose based on creatinine clearance (CLcr) as indicated in Table 2 2

From the Research

Lyrica Dosing

• The dosing of Lyrica (pregabalin) varies depending on the indication and patient response 3
• For diabetic peripheral neuropathy, the recommended dose is 300 mg/day 3
• For postherpetic neuralgia, the recommended dose is 300-600 mg/day 3
• For fibromyalgia, the recommended dose is 300-450 mg/day 3
• The dose-response of pregabalin for pain, Patient Global Impression of Change (PGIC), and sleep quality measures is relevant for physicians treating these patients 3
• A hyperbolic Emax dose-response model examined the dose-response of pregabalin for pain, PGIC, and sleep quality, and found that the likelihood of patients experiencing pain relief and improvements in PGIC and sleep quality increased in a dose-dependent manner with increasing doses 3

Pharmacokinetics

• Pregabalin controlled-release (CR) formulation has been studied in healthy volunteers, and found to have equivalent total exposure to the immediate-release (IR) formulation 4
• The relative bioavailability of pregabalin CR was 93-97% of pregabalin IR, and bioequivalence criteria were met 4
• Administration of a two-tablet dose of pregabalin CR was bioequivalent to one-tablet pregabalin CR 4
• Pregabalin CR pharmacokinetic parameters were dose proportional following administration of 82.5-660 mg/day pregabalin CR 4

Efficacy and Safety

• Pregabalin has been shown to be effective in reducing pain and improving sleep quality in patients with diabetic peripheral neuropathy, postherpetic neuralgia, and fibromyalgia 5, 3
• Common adverse events associated with pregabalin include dizziness, somnolence, and weight gain 3
• The incidence of adverse events is highest after 1 week of treatment, and prevalence rates decrease steadily after 1 week of treatment 3
• Pregabalin has been found to be cost-effective compared to gabapentin in the management of peripheral neuropathic pain associated with post-herpetic neuralgia and diabetic neuropathy 6