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.
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.
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 ongoing pain and are tolerating 330 mg daily. The maximum recommended dose of LYRICA CR is 660 mg once daily.
Conversion from LYRICA Capsules to LYRICA CR Modified Release Tablets: When switching from LYRICA Capsules to LYRICA CR, on the day of the switch, instruct patients to take their morning dose of LYRICA Capsules as prescribed and initiate LYRICA CR therapy after an evening meal. (See Table 2.)
Discontinuation of pregabalin: If pregabalin has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week.
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 haemodialysis. Those patients should receive LYRICA Capsules.
In view of dose-dependent adverse reactions and since 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 3. 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: (See equation.)
Next, refer to the Dosage and Administration 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 3 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.) (See Table 3.)
Use in patients with hepatic impairment: No dosage adjustment is required for patients with hepatic impairment (see Pharmacology: Pharmacokinetics: Pharmacokinetics in special patient groups under Actions).
Use in children and adolescents (12 to 17 years of age): The safety and effectiveness of pregabalin in pediatric patients below the age of 12 years and adolescents has not been established.
The use in children is not recommended (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Use in the elderly (over 65 years of age): Elderly patients may require a dose reduction of pregabalin due to decreased renal function (see Pharmacology: Pharmacokinetics: Pharmacokinetics in special patient groups under Actions).
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