Generic Name

Pregabalin

Brand Names
Lyrica, Pregablin
FDA approval date: December 30, 2004
Form: Tablet, Capsule, Solution

What is Lyrica (Pregabalin)?

LYRICA is indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy, Management of postherpetic neuralgia, Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, Management of fibromyalgia, Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for:, Neuropathic pain associated with diabetic peripheral neuropathy , Postherpetic neuralgia , Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older , Fibromyalgia , Neuropathic pain associated with spinal cord injury

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Brand Information

    Lyrica (PREGABALIN)
    1INDICATIONS AND USAGE
    LYRICA is indicated for:
    • Management of neuropathic pain associated with diabetic peripheral neuropathy
    • Management of postherpetic neuralgia
    • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
    • Management of fibromyalgia
    • Management of neuropathic pain associated with spinal cord injury
    2DOSAGE FORMS AND STRENGTHS
    Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg
    Oral Solution: 20 mg/mL
    [see
    3CONTRAINDICATIONS
    LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy
    4ADVERSE REACTIONS
    The following serious adverse reactions are described elsewhere in the labeling:
    • Angioedema
    • Hypersensitivity
    • Suicidal Behavior and Ideation
    • Respiratory Depression
    • Dizziness and Somnolence
    • Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation
    • Peripheral Edema
    • Weight Gain
    • Tumorigenic Potential
    • Ophthalmological Effects
    • Creatine Kinase Elevations
    • Decreased Platelet Count
    • PR Interval Prolongation
    4.1Clinical Trials Experience
    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
    In all controlled and uncontrolled trials across various patient populations during the premarketing development of LYRICA, more than 10,000 patients have received LYRICA. Approximately 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years.
    4.2Postmarketing Experience
    The following adverse reactions have been identified during postapproval use of LYRICA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
    Nervous System Disorders – Headache
    Gastrointestinal Disorders – Nausea, Diarrhea
    Reproductive System and Breast Disorders – Gynecomastia, Breast Enlargement
    Skin and subcutaneous tissue disorders – Bullous pemphigoid
    There are postmarketing reports of life-threatening or fatal respiratory depression in patients taking LYRICA with opioids or other CNS depressants, or in the setting of underlying respiratory impairment.
    In addition, there are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when LYRICA was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
    5DRUG INTERACTIONS
    Since LYRICA is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement.
    6DESCRIPTION
    Pregabalin is described chemically as (
    Chemical Structure
    Pregabalin is a white to off-white, crystalline solid with a pK
    LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.
    LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.
    7PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide).
    8PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Label
    Pfizer
    NDC 0071-1012-68
    Lyrica®
    (pregabalin)
    capsules
    CV
    25 mg
    ALWAYS DISPENSE WITH
    MEDICATION GUIDE
    90 Capsules
    PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Label
    9PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack
    Lyrica
    (pregabalin)
    Capsule
    CV
    50 mg
    DIST BY PARKE-DAVIS
    LOT 00000VX EXP XXX 00
    PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack
    10PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton
    Pfizer
    NDC 0071-1013-41
    Lyrica®
    (pregabalin) capsules
    CV
    50 mg
    ALWAYS DISPENSE WITH MEDICATION GUIDE
    For in-institution use only
    100 Capsules
    PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton
    11PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label
    Pfizer
    NDC 0071-1013-68
    Lyrica®
    (pregabalin)
    capsules
    CV
    50 mg
    ALWAYS DISPENSE WITH
    MEDICATION GUIDE
    90 Capsules
    PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label
    12PRINCIPAL DISPLAY PANEL - 75 mg Capsule Blister Pack
    Lyrica
    (pregabalin)
    Capsule
    CV
    75 mg
    DIST BY PARKE-DAVIS
    LOT 00000VX EXP XXX 00
    PRINCIPAL DISPLAY PANEL - 75 mg Capsule Blister Pack
    13PRINCIPAL DISPLAY PANEL - 75 mg Capsule Blister Pack Carton
    Pfizer
    NDC 0071-1014-41
    Lyrica®
    (pregabalin) capsules
    CV
    75 mg
    ALWAYS DISPENSE WITH MEDICATION GUIDE
    For in-institution use only
    100 Capsules
    PRINCIPAL DISPLAY PANEL - 75 mg Capsule Blister Pack Carton
    14PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label
    Pfizer
    NDC 0071-1014-68
    Lyrica®
    (pregabalin)
    capsules
    CV
    75 mg
    ALWAYS DISPENSE WITH
    MEDICATION GUIDE
    90 Capsules
    PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label
    15PRINCIPAL DISPLAY PANEL - 100 mg Capsule Blister Pack
    Lyrica
    (pregabalin)
    Capsule
    CV
    100 mg
    DIST BY PARKE-DAVIS
    LOT 00000VX EXP XXX 00
    PRINCIPAL DISPLAY PANEL - 100 mg Capsule Blister Pack
    16PRINCIPAL DISPLAY PANEL - 100 mg Capsule Blister Pack Carton
    Pfizer
    NDC 0071-1015-41
    Lyrica®
    (pregabalin) capsules
    CV
    100 mg
    ALWAYS DISPENSE WITH MEDICATION GUIDE
    For in-institution use only
    100 Capsules
    PRINCIPAL DISPLAY PANEL - 100 mg Capsule Blister Pack Carton
    17PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label
    Pfizer
    NDC 0071-1015-68
    Lyrica®
    (pregabalin)
    capsules
    CV
    100 mg
    ALWAYS DISPENSE WITH
    MEDICATION GUIDE
    90 Capsules
    PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label
    18PRINCIPAL DISPLAY PANEL - 150 mg Capsule Blister Pack
    Lyrica
    (pregabalin)
    Capsule
    CV
    150 mg
    DIST BY PARKE-DAVIS
    LOT 00000VX EXP XXX 00
    PRINCIPAL DISPLAY PANEL - 150 mg Capsule Blister Pack
    19PRINCIPAL DISPLAY PANEL - 150 mg Capsule Blister Pack Carton
    Pfizer
    NDC 0071-1016-41
    Lyrica®
    (pregabalin) capsules
    CV
    150 mg
    ALWAYS DISPENSE WITH MEDICATION GUIDE
    For in-institution use only
    100 Capsules
    PRINCIPAL DISPLAY PANEL - 150 mg Capsule Blister Pack Carton
    20PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Label
    Pfizer
    NDC 0071-1016-68
    Lyrica®
    (pregabalin)
    capsules
    CV
    150 mg
    ALWAYS DISPENSE WITH
    MEDICATION GUIDE
    1. 90 Capsules
    PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Label
    21PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label
    Pfizer
    NDC 0071-1017-68
    Lyrica®
    (pregabalin)
    capsules
    CV
    200 mg
    ALWAYS DISPENSE WITH
    MEDICATION GUIDE
    90 Capsules
    PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label
    22PRINCIPAL DISPLAY PANEL - 225 mg Capsule Bottle Label
    Pfizer
    NDC 0071-1019-68
    Lyrica®
    (pregabalin)
    capsules
    CV
    225 mg
    ALWAYS DISPENSE WITH
    MEDICATION GUIDE
    1. 90 Capsules
    PRINCIPAL DISPLAY PANEL - 225 mg Capsule Bottle Label
    23PRINCIPAL DISPLAY PANEL - 300 mg Capsule Bottle Label
    Pfizer
    NDC 0071-1018-68
    Lyrica®
    (pregabalin)
    capsules
    CV
    300 mg
    ALWAYS DISPENSE WITH
    MEDICATION GUIDE
    1. 90 Capsules
    PRINCIPAL DISPLAY PANEL - 300 mg Capsule Bottle Label
    24PRINCIPAL DISPLAY PANEL - 20 mg Bottle Label
    Pfizer
    NDC 0071-1020-01
    Lyrica®
    (pregabalin)
    CV
    20 mg per mL
    oral solution
    ALWAYS DISPENSE WITH MEDICATION GUIDE
    FOR ORAL USE ONLY
    16 fl oz (473 mL)
    PRINCIPAL DISPLAY PANEL - 20 mg Bottle Label
    25PRINCIPAL DISPLAY PANEL - 20 mg Bottle Carton
    Pfizer
    NDC 0071-1020-01
    Lyrica
    CV
    20 mg per mL
    oral solution
    ALWAYS DISPENSE WITH MEDICATION GUIDE
    FOR ORAL USE ONLY
    16 fl oz (473 mL)
    PRINCIPAL DISPLAY PANEL - 20 mg Bottle Carton
    Lyrica has been selected.