Pregabalindosage

Pregabalin extended-release tablets should be administered once daily after an evening meal. It should be swallowed whole and should not be split, crushed, or chewed. Dosing recommendations for pregabalin extended-release tablets: Indication Dosing Regimen Initial Dose Maximum Dose DPN Pain Single dose per day 165 mg/day 330 mg/day within 1 week. PHN Single dose per day 165 mg/day 330 mg/day within 1 week. Maximum dose of 660 mg/day. Conversion from LYRICA Capsules or Oral Solution to pregabalin extended-release tablets: See full prescribing information. Dose modification recommended in patients with renal impairment.

2.1 Important

Dosage and Administration Instructions Pregabalin extended-release tablets should be administered once daily after an evening meal. Pregabalin extended-release tablets should be swallowed whole and should not be split, crushed, or chewed. When discontinuing pregabalin extended-release tablets, taper gradually over a minimum of 1 week. Instruct patients that if they miss taking their dose of pregabalin extended-release tablets after an evening meal, then they should take their usual dose of pregabalin extended-release tablets prior to bedtime following a snack. If they miss taking the dose of pregabalin extended-release tablets prior to bedtime, then they should take their usual dose of pregabalin extended-release tablets following a morning meal. If they miss taking the dose of pregabalin extended-release tablets following the morning meal, then they should take their usual dose of pregabalin extended-release tablets at the usual time that evening following an evening meal.

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 pregabalin extended-release tablets 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 pregabalin extended-release tablets.

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 pregabalin extended-release tablets, 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 pregabalin extended-release tablets is 660 mg once daily.

2.4 Conversion from LYRICA

Capsules or Oral Solution to Pregabalin Extended-Release Tablets When switching from LYRICA to pregabalin extended-release tablets on the day of the switch, instruct patients to take their morning dose of LYRICA as prescribed and initiate pregabalin extended-release tablets therapy after an evening meal. Table 1. Conversion from LYRICA Capsules or Oral Solution to Pregabalin Extended-Release Tablets LYRICA Total Daily Dose (dosed 2 or 3 times daily) Pregabalin Extended-Release Tablets 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 247.5 mg = 3 × 82.5 mg tablets taken once a day. 300 mg/daily 330 mg/day 450 mg/daily 495 mg/day 495 mg = 3 × 165 mg tablets taken once a day. 600 mg/daily 660 mg/day 660 mg = 2 × 330 mg tablets taken once a day.

2.5 Patients with

Renal Impairment Use of pregabalin extended-release tablets 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 pregabalin extended-release tablets 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: Pregabalin Extended-Release Tablets Dosage Adjustment Based on Renal Function Creatinine Clearance (CLcr) (mL/min) Total Pregabalin Extended-Release Tablets Daily Dose (mg/day) Dose Regimen greater than or equal to 60 165 330 495 495 mg = 3 × 165 mg tablets taken once a day. 660 660 mg = 2 × 330 mg tablets taken once a day. Once a day 30–60 82.5 165 247.5 247.5 mg = 3 × 82.5 mg tablets taken once a day 330 Once a day less than 30/hemodialysis Dose with LYRICA PRINCIPAL DISPLAY PANEL - 50 mg/500 mg Tablet Bottle Label