HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA.
LYRICA(pregabalin)Capsules, CV
LYRICA (pregabalin) Oral Solution, CV
Initial U.S. Approval: 2004
INDICATIONS AND USAGE
LYRICA is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1)
Postherpetic neuralgia (PHN) (1)
Adjunctive therapy for adult patients with partial onset seizures (1)
Fibromyalgia (1)
Neuropathic pain associated with spinal cord injury (1)
DOSAGE AND ADMINISTRATION
For all indications, begin dosing at 150 mg/day. (2.1, 2.2, 2.3, 2.4, 2.5)
Dosing recommendations:
INDICATION Dosing Regimen Maximum Dose
DPN Pain (2.1) 3 divided doses per day 300 mg/day within 1 week
PHN (2.2) 2 or 3 divided doses per day 300 mg/day within 1 week. Maximum dose of 600 mg/day.
Adjunctive Therapy for Adult Patients with Partial Onset Seizures (2.3) 2 or 3 divided doses per day Maximum dose of 600 mg/day.
Fibromyalgia (2.4) 2 divided doses per day 300 mg/day within 1 week.
Maximum dose of 450 mg/day.
Neuropathic Pain Associated with Spinal Cord Injury (2.5) 2 divided doses per day 300 mg/day within 1 week. Maximum dose of 600 mg/day.
Dose should be adjusted in patients with reduced renal function. (2.6)
Oral Solution Concentration and Dispensing (2.7)
DOSAGE FORMS AND STRENGTHS
Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg. (3)
Oral Solution: 20 mg/ mL. (3)
CONTRAINDICATIONS
Known hypersensitivity to pregabalin or any of its components. (4)
WARNINGS AND PRECAUTIONS
Angioedema (e.g., swelling of the throat, head and neck) can occur, and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in these cases. (5.1)
Hypersensitivity reactions (e.g. hives, dyspnea, and wheezing) can occur. Discontinue LYRICA immediately in these patients. (5.2)
Increased seizure frequency may occur in patients with seizure disorders if LYRICA is rapidly discontinued. Withdraw LYRICA gradually over a minimum of 1 week. (5.3)
Antiepileptic drugs, including LYRICA, increase the risk of suicidal thoughts or behavior. (5.4)
LYRICA may cause peripheral edema. Exercise caution when co-administering LYRICA and thiazolidinedione antidiabetic agents. (5.5)
LYRICA may cause dizziness and somnolence and impair patients' ability to drive or operate machinery.(5.6)
ADVERSE REACTIONS
Most common adverse reactions (greater than or equal to 5% and twice placebo) are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at (800) 438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
Pregnancy: May cause fetal harm. Advise of potential risk to the fetus.(8.1 )
Lactation: Breastfeeding is not recommended. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 1/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
2.2 Pos