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Lyrica

INDICATIONS

LYRICA is indicated for:

  • Management of neuropathic pain associated with diabetic peripheral neuropathy
  • Management of postherpetic neuralgia
  • Adjunctive therapy for adult patients with partial onset seizures
  • Management of fibromyalgia
  • Management of neuropathic pain associated with spinal cord injury

DOSAGE AND ADMINISTRATION

LYRICA is given orally with or without food.

When discontinuing LYRICA, taper gradually over a minimum of 1 week.

Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

The maximum recommended dose of LYRICA 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. Because LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see Patients with Renal Impairment].

Although LYRICA 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].

Postherpetic Neuralgia

The recommended dose of LYRICA 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. 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. Because LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see Patients with Renal Impairment].

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 LYRICA, 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].

Adjunctive Therapy For Adult Patients With Partial Onset Seizures

LYRICA at doses of 150 to 600 mg/day has been shown to be effective as adjunctive therapy in the treatment of partial onset seizures in adults. Both the efficacy and adverse event profiles of LYRICA have been shown to be dose-related. Administer the total daily dose in two or three divided doses. In general, it is recommended that patients be started on a total daily dose no greater than 150 mg/day (75 mg two times a day, or 50 mg three times a day). Based on individual patient response and tolerability, the dose may be increased to a maximum dose of 600 mg/day.

Because LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see Patients with Renal Impairment].

The effect of dose escalation rate on the tolerability of LYRICA has not been formally studied.

The efficacy of add-on LYRICA in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of LYRICA with gabapentin cannot be offered.

Management Of Fibromyalgia

The recommended dose of LYRICA for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although LYRICA was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see ADVERSE REACTIONS]. Because LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see Patients with Renal Impairment].

Neuropathic Pain Associated With Spinal Cord Injury

The recommended dose range of LYRICA for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate LYRICA may be treated with up to 300 mg two times a day [see Clinical Studies]. Because LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see Patients with Renal Impairment].

Patients With Renal Impairment

In view of dose-dependent adverse reactions and since LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function. Base the dose adjustment in patients with renal impairment on creatinine clearance (CLcr), as indicated in Table 1. To use this dosing table, an estimate of the patient's CLcr in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft and Gault equation:

Males: (weight in kg) x (140 – age)
(72) x serum creatinine (mg/100 mL)
Females (0.85) x (above value)

Next, refer to the Dosage and Administration section to determine the recommended total daily dose based on indication, for a patient with normal renal function (CLcr ≥ 60 mL/min). Then refer to Table 1 to determine the corresponding renal adjusted dose.

(For example: A patient initiating LYRICA therapy for postherpetic neuralgia with normal renal function (CLcr ≥ 60 mL/min), receives a total daily dose of 150 mg/day pregabalin. Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a total daily dose of 75 mg/day pregabalin administered in two or three divided doses.)

For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment (see Table 1).

Table 1: Pregabalin Dosage Adjustment Based on Renal Function

Creatinine Clearance (CLcr) (mL/min) Total Pregabalin Daily Dose (mg/day)* Dose Regimen
≥ 60 150 300 450 600 BID or TID
30–60 75 150 225 300 BID or TID
15–30 25–50 75 100–150 150 QD or BID
< 15 25 25–50 50–75 75 QD
Supplementary dosage following hemodialysis (mg)†
Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mg
Patients on the 25–50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg
Patients on the 50–75 mg QD regimen: take one supplemental dose of 75 mg or 100 mg
Patients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg
ID= Three divided doses; BID = Two divided doses; QD = Single daily dose.
* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose.
† Supplementary dose is a single additional dose.

Oral Solution Concentration And Dispensing

The oral solution is 20 mg pregabalin per milliliter (mL) and prescriptions should be written in milligrams (mg). The pharmacist will calculate the applicable dose in mL for dispensing (e.g., 150 mg equals 7.5 mL oral solution).

HOW SUPPLIED

Dosage Forms And Strengths

Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg Oral Solution: 20 mg/mL [see DESCRIPTION and Storage and Handling].

25 mg capsules

White, hard-gelatin capsule printed with black ink “Pfizer” on the cap, “PGN 25” on the body; available in:

Bottles of 90: NDC 0071-1012-68

50 mg capsules

White, hard-gelatin capsule printed with black ink “Pfizer” on the cap, “PGN 50” and an ink band on the body, available in:

Bottles of 90: NDC 0071-1013-68
Unit-Dose Blister Packages of 100: NDC 0071-1013-41

75 mg capsules

White/orange hard gelatin capsule printed with black ink “Pfizer” on the cap, “PGN 75” on the body; available in:

Bottles of 90: NDC 0071-1014-68
Unit-Dose Blister Packages of 100: NDC 0071-1014-41

100 mg capsules

Orange, hard-gelatin capsule printed with black ink “Pfizer” on the cap, “PGN 100” on the body, available in:

Bottles of 90: NDC 0071-1015-68
Unit-Dose Blister Packages of 100: NDC 0071-1015-41

150 mg capsules

White hard gelatin capsule printed with black ink “Pfizer” on the cap, “PGN 150” on the body, available in:

Bottles of 90: NDC 0071-1016-68
Unit-Dose Blister Packages of 100: NDC 0071-1016-41

200 mg capsules

Light orange hard gelatin capsule printed with black ink “Pfizer” on the cap, “PGN 200” on the body, available in:

Bottles of 90: NDC 0071-1017-68

225 mg capsules

White/light orange hard gelatin capsule printed with black ink “Pfizer” on the cap, “PGN 225” on the body; available in:

Bottles of 90: NDC 0071-1019-68

300 mg capsules

White/orange hard gelatin capsule printed with black ink “Pfizer” on the cap, “PGN 300” on the body, available in:

Bottles of 90: NDC 0071-1018-68

20 mg/mL oral solution

16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:

16 fluid ounce bottle NDC 0071-1020-01

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).

See FDA-Approved Medication Guide

Distributed by: Parke Davis, Division of Pfizer Inc, NY, NY 10017. Revised: 12/2013

Last reviewed on RxList: 1/3/2014
This monograph has been modified to include the generic and brand name in many instances.

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