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LYRICA®, CV Highlights (pregabalin)

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

RECENT MAJOR CHANGES

Warnings and Precautions, Respiratory Depression (5.4)4/2020

INDICATIONS AND USAGE

LYRICA is indicated for:

  • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1)
  • Postherpetic neuralgia (PHN) (1)
  • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older (1)
  • Fibromyalgia (1)
  • Neuropathic pain associated with spinal cord injury (1)

DOSAGE AND ADMINISTRATION

  • For adult indications, begin dosing at 150 mg/day. For partial-onset seizure dosing in pediatric patients 1 month of age and older, refer to section 2.4. (2.2, 2.3, 2.4, 2.5, 2.6)
  • Dosing recommendations:
INDICATIONDosing RegimenMaximum Dose
DPN Pain (2.2)3 divided doses per day300 mg/day within 1 week
PHN (2.3)2 or 3 divided doses per day300 mg/day within 1 week.
Maximum dose of 600 mg/day.
Adjunctive Therapy for Partial-Onset Seizures in Pediatric and Adult Patients Weighing 30 kg or More (2.4)2 or 3 divided doses per dayMaximum dose of 600 mg/day.
Adjunctive Therapy for Partial-Onset Seizures in Pediatric Patients Weighing Less than 30 kg (2.4)1 month to less than 4 years:
  3 divided doses per day
4 years and older:
  2 or 3 divided doses per day
14 mg/kg/day.
Fibromyalgia (2.5)2 divided doses per day300 mg/day within 1 week.
Maximum dose of 450 mg/day.
Neuropathic Pain Associated with Spinal Cord Injury (2.6)2 divided doses per day300 mg/day within 1 week.
Maximum dose of 600 mg/day.
  • Dose should be adjusted in adult patients with reduced renal function. (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)
  • Antiepileptic drugs, including LYRICA, increase the risk of suicidal thoughts or behavior. (5.3)
  • Respiratory depression: May occur with LYRICA, when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate. (5.4)
  • LYRICA may cause dizziness and somnolence and impair patients' ability to drive or operate machinery. (5.5)
  • Increased seizure frequency or other adverse reactions may occur if LYRICA is rapidly discontinued. Withdraw LYRICA gradually over a minimum of 1 week. (5.6)
  • LYRICA may cause peripheral edema. Exercise caution when co-administering LYRICA and thiazolidinedione antidiabetic agents. (5.7)

ADVERSE REACTIONS

Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention). (6.1)

Most common adverse reactions (greater than or equal to 5% and twice placebo) in pediatric patients for the treatment of partial-onset seizures are increased weight and increased appetite. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 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: 6/2020

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch