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1. Indications and Usage

Pregabalin capsules are indicated for:

• Management of neuropathic pain associated with diabetic peripheral neuropathy

• Management of postherpetic neuralgia

• Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older

• Management of fibromyalgia

• Management of neuropathic pain associated with spinal cord injury

The pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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2. Dosage and Administration

2.1 Important Administration Instructions

Pregabalin capsules are 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 capsule is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.

Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended [see ADVERSE REACTIONS (6.1)].

2.3 Postherpetic Neuralgia in Adults

The recommended dose of pregabalin capsule is 75 mg to 150 mg two times a day, or 50 mg to 100 mg three times a day (150mg/day to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.

Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate pregabalin, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily [see ADVERSE REACTIONS (6.1)].

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2.4 Adjunctive Therapy for Partial-Onset Seizures in Patients 17 Years of Age and Older

The recommended dosage for adult patients 17 years of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. Based on clinical response and tolerability, dosage may be increased, approximately weekly.

Table 1: Recommended Dosage for Adult Patients 17 Years and Older