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.
|LYRICA Total Daily Dose|
(dosed 2 or 3 times daily)
|LYRICA CR Dose|
(dosed 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:
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.)
|Creatinine Clearance (CLcr)|
|Total LYRICA CR Daily Dose|
|greater than or equal to 60||165||330||495*||660†||Once a day|
|30–60||82.5||165||247.5‡||330||Once a day|
|less than 30/hemodialysis||Dose with LYRICA|