Lyrica CR

LYRICA CR- pregabalin tablet, film coated, extended release
U.S. Pharmaceuticals

1 INDICATIONS AND USAGE

LYRICA CR is indicated for the management of:

  • Neuropathic pain associated with diabetic peripheral neuropathy
  • Postherpetic neuralgia

Efficacy of LYRICA CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

LYRICA CR should be administered once daily after an evening meal.

LYRICA CR should be swallowed whole and should not be split, crushed, or chewed.

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

Instruct patients that if they miss taking their dose of LYRICA CR after an evening meal, then they should take their usual dose of LYRICA CR prior to bedtime following a snack. If they miss taking the dose of LYRICA CR prior to bedtime, then they should take their usual dose of LYRICA CR following a morning meal. If they miss taking the dose of LYRICA CR following the morning meal, then they should take their usual dose of LYRICA CR at the usual time that evening following an evening meal [see Patient Counseling Information (17)].

2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

Begin dosing at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of LYRICA CR is 330 mg once daily.

Although LYRICA was studied at 600 mg/day, there was no evidence that this dose conferred additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions with LYRICA, treatment with doses above 330 mg/day is not recommended for LYRICA CR.

2.3 Postherpetic Neuralgia

Begin dosing at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability.

Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate LYRICA CR, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of LYRICA CR is 660 mg once daily.

2.4 Conversion from LYRICA Capsules or Oral Solution to LYRICA CR

When switching from LYRICA to LYRICA CR on the day of the switch, instruct patients to take their morning dose of LYRICA as prescribed and initiate LYRICA CR therapy after an evening meal.

Table 1. Conversion from LYRICA Capsules or Oral Solution to LYRICA CR
LYRICA Total Daily Dose(dosed 2 or 3 times daily) LYRICA CR Dose(dosed once a day)
*
247.5 mg = 3 × 82.5 mg tablets taken once a day.
495 mg = 3 × 165 mg tablets taken once a day.
660 mg = 2 × 330 mg tablets taken once a day.
75 mg/daily 82.5 mg/day
150 mg/daily 165 mg/day
225 mg/daily 247.5 mg/day *
300 mg/daily 330 mg/day
450 mg/daily 495 mg/day
600 mg/daily 660 mg/day

2.5 Patients with Renal Impairment

Use of LYRICA CR is not recommended for patients with creatinine clearance (CLcr) less than 30 mL/min or who are undergoing hemodialysis. Those patients should receive LYRICA.

In view of dose-dependent adverse reactions and because pregabalin 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 CLcr, as indicated in Table 2. To use the dosing tables, 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:

Equation
(click image for full-size original)

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 greater than or equal to 60 mL/min). Then refer to Table 2 to determine the corresponding renal adjusted dose.

(For example: A patient initiating LYRICA CR therapy for postherpetic neuralgia with normal renal function [CLcr greater than or equal to 60 mL/min], receives a single daily dose of 165 mg/day pregabalin. Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a single daily dose of 82.5 mg.)

Table 2. LYRICA CR Dosage Adjustment Based on Renal Function
Creatinine Clearance (CLcr)(mL/min)Total LYRICA CR Daily Dose(mg/day)Dose Regimen
*
495 mg = 3 × 165 mg tablets taken once a day.
660 mg = 2 × 330 mg tablets taken once a day.
247.5 mg = 3 × 82.5 mg tablets taken once a day.
greater than or equal to 60165330495*660Once a day
30–6082.5165247.5330Once a day
less than 30/hemodialysisDose with LYRICA

3 DOSAGE FORMS AND STRENGTHS

Extended-release tablets: 82.5 mg, 165 mg, and 330 mg [see Description (11) and How Supplied/Storage and Handling (16)].

LYRICA CR Tablets
Tablet Strength (mg) Tablet Description
82.5 mg Light blue, film-coated, almond-shaped tablet debossed with Pfizer on 1 side and PGN 82.5 on the other side
165 mg Beige, film-coated, almond-shaped tablet debossed with Pfizer on 1 side and PGN 165 on the other side
330 mg Rose, film-coated, almond-shaped tablet debossed with Pfizer on 1 side and PGN 330 on the other side

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