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. Dosing
should begin at 50 mg three times a day (150 mg/day) and may be increased to
300 mg/day within 1 week based on efficacy and tolerability. Because LYRICA is eliminated
primarily by renal excretion, the dose should be adjusted for patients with reduced
renal function (see Dosage and Administration).
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. Dosing should begin at 75 mg two times a day, or 50 mg three
times a day (150 mg/day) and may be increased to 300 mg/day within 1 week based
on efficacy and tolerability. Because LYRICA is eliminated primarily by renal excretion,
the dose should be adjusted for patients with reduced renal function (see Dosage
and Administration).
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, dosing above 300 mg/day should be reserved only 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. The total daily dose
should be divided and given either two or three times daily. Both the efficacy and
adverse event profiles of LYRICA have been shown to be dose-related. 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, the dose should be adjusted
for patients with reduced renal function (see Dosage and Administration).
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. Dosing should
begin at 75 mg two times a day (150 mg/day) and 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, the dose should be adjusted for
patients with reduced renal function (creatinine clearance less than 60 mL/min -
see Patients with Renal Impairment) (see Dosage and Administration).
Patients with Renal Impairment
In view of dose-dependent adverse reactions and since LYRICA is eliminated primarily
by renal excretion, the dose should be adjusted in patients with reduced renal function.
Dosage adjustment in patients with renal impairment should be based 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:
For patients undergoing hemodialysis, pregabalin daily dose should be adjusted based
on renal function. In addition to the daily dose adjustment, a supplemental dose
should be given immediately following every 4-hour hemodialysis treatment (see Table
1).
Table 1: Pregabalin Dosage Adjustment Based on Renal Function
Dosage Forms and Strengths
Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg (see Description and How Supplied/Storage and Handling).