Lyrica Oral Solution

— THERAPEUTIC CATEGORIES —
  • Fibromyalgia
  • Nonnarcotic analgesics
  • Seizure disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Lyrica Oral Solution Generic Name & Formulations

    Legal Class

    CV

    General Description

    Pregabalin 20mg/mL.

    Pharmacological Class

    Alpha-2 delta ligand.

    See Also

    How Supplied

    Caps—90; Soln—16oz

    Manufacturer

    Pfizer Inc.

    Mechanism of Action

    Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, some results related to pregabalin (such as gabapentin) suggest that binding to the alpha2-delta subunit may be involved in pregabalin's anti-nociceptive and antiseizure effects in animals.

    Lyrica Oral Solution Indications

    Indications

    Fibromyalgia.

    Lyrica Oral Solution Dosage and Administration

    Adult

    Initially 75mg twice daily, may increase to 150mg twice daily within 1 week as tolerated; max 450mg/day. Renal impairment (CrCl <60mL/min): reduce dose (see full labeling); hemodialysis: give supplemental dose after session.

    Children

    Not established.

    Lyrica Oral Solution Contraindications

    Not Applicable

    Lyrica Oral Solution Boxed Warnings

    Not Applicable

    Lyrica Oral Solution Warnings/Precautions

    Warnings/Precautions

    Discontinue if angioedema, hypersensitivity reactions, myopathy or markedly elevated creatine kinase levels occur. Monitor for new or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood/behavior. Underlying respiratory depression; monitor and consider initiating at a low dose. CHF (w. NYHA Class III/IV status). Ocular conditions. Diabetes (monitor skin integrity). Avoid abrupt cessation (taper over ≥1 week). Pregnancy. Nursing mothers: not recommended.

    Lyrica Oral Solution Pharmacokinetics

    Absorption

    Peak plasma concentration: 1.5 hours (capsules). Oral bioavailability: ≥90%. Steady state: achieved within 24–48 hours.

    Distribution

    Apparent volume of distribution: ~0.5 L/kg.

    Elimination

    Renal (90%). Half-life: 6.3 hours.

    Lyrica Oral Solution Interactions

    Interactions

    Increased risk for serious respiratory depression when concomitant CNS depressants, opioids. Potentiates CNS depression with alcohol, other CNS depressants. Additive edema, weight gain with thiazolidinediones. Increased risk of angioedema with concomitant ACEIs.

    Lyrica Oral Solution Adverse Reactions

    Adverse Reactions

    Dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, thinking abnormal (primarily difficulty with concentration/attention); elevated creatine kinase, decreased platelets, PR prolongation, male-mediated teratogenicity; may be tumorigenic. Also in children: increased appetite.

    Lyrica Oral Solution Clinical Trials

    See Literature

    Lyrica Oral Solution Note

    Notes

    Register patients in North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling (888) 233-2334.

    Lyrica Oral Solution Patient Counseling

    See Literature

    Lyrica Oral Solution Generic Name & Formulations

    Legal Class

    CV

    General Description

    Pregabalin 20mg/mL.

    Pharmacological Class

    Alpha-2 delta ligand.

    See Also

    How Supplied

    Caps—90; CR tabs—30; Soln—16oz

    Manufacturer

    Pfizer Inc.

    Mechanism of Action

    Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, some results related to pregabalin (such as gabapentin) suggest that binding to the alpha2-delta subunit may be involved in pregabalin's anti-nociceptive and antiseizure effects in animals.

    Lyrica Oral Solution Indications

    Indications

    Neuropathic pain associated with diabetic peripheral neuropathy (DPN) or spinal cord injury. Postherpetic neuralgia (PHN).

    Lyrica Oral Solution Dosage and Administration

    Adult

    DPN: initially 50mg 3 times daily, may increase to 100mg 3 times daily within 1 week. Spinal cord injury: initially 75mg twice daily, may increase to 150mg twice daily within 1 week, then max 600mg/day after 2 weeks as tolerated. PHN: initially 75mg twice daily or 50mg 3 times daily; max 300mg/day after 1 week then 600mg/day after 2 weeks as tolerated (see full labeling). For all: renal impairment (CrCl <60mL/min): reduce dose (see full labeling); hemodialysis: give supplemental dose after session.

    Children

    Not established.

    Lyrica Oral Solution Contraindications

    Not Applicable

    Lyrica Oral Solution Boxed Warnings

    Not Applicable

    Lyrica Oral Solution Warnings/Precautions

    Warnings/Precautions

    Discontinue if angioedema, hypersensitivity reactions, myopathy or markedly elevated creatine kinase levels occur. Monitor for new or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood/behavior. Underlying respiratory depression; monitor and consider initiating at a low dose. CHF (w. NYHA Class III/IV status). Ocular conditions. Diabetes (monitor skin integrity). Avoid abrupt cessation (taper over ≥1 week). Pregnancy. Nursing mothers: not recommended.

    Lyrica Oral Solution Pharmacokinetics

    Absorption

    Peak plasma concentration: 1.5 hours (capsules). Oral bioavailability: ≥90%. Steady state: achieved within 24–48 hours.

    Distribution

    Apparent volume of distribution: ~0.5 L/kg.

    Elimination

    Renal (90%). Half-life: 6.3 hours.

    Lyrica Oral Solution Interactions

    Interactions

    Increased risk for serious respiratory depression when concomitant CNS depressants, opioids. Potentiates CNS depression with alcohol, other CNS depressants. Additive edema, weight gain with thiazolidinediones. Increased risk of angioedema with concomitant ACEIs.

    Lyrica Oral Solution Adverse Reactions

    Adverse Reactions

    Dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, thinking abnormal (primarily difficulty with concentration/attention); elevated creatine kinase, decreased platelets, PR prolongation, male-mediated teratogenicity; may be tumorigenic. Also in children: increased appetite.

    Lyrica Oral Solution Clinical Trials

    See Literature

    Lyrica Oral Solution Note

    Notes

    Register patients in North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling (888) 233-2334.

    Lyrica Oral Solution Patient Counseling

    See Literature

    Lyrica Oral Solution Generic Name & Formulations

    Legal Class

    CV

    General Description

    Pregabalin 20mg/mL.

    Pharmacological Class

    Alpha-2 delta ligand.

    See Also

    How Supplied

    Caps—90; Soln—16oz

    Manufacturer

    Pfizer Inc.

    Mechanism of Action

    Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, some results related to pregabalin (such as gabapentin) suggest that binding to the alpha2-delta subunit may be involved in pregabalin's anti-nociceptive and antiseizure effects in animals.

    Lyrica Oral Solution Indications

    Indications

    Adjunct in partial onset seizures.

    Lyrica Oral Solution Dosage and Administration

    Adult

    Give in 2–3 divided doses. ≥17yrs: initially 150mg/day; max 600mg/day. Renal impairment (CrCl <60mL/min): reduce dose (see full labeling); hemodialysis: give supplemental dose after session.

    Children

    <1 month: not established. Give in 2–3 divided doses (3 divided doses for <4yrs). ≥1 month (<30kg): initially 3.5mg/kg/day; max 14mg/kg/day; (≥30kg): initially 2.5mg/kg/day, max 10mg/kg/day (up to 600mg/day). Renal impairment (CrCl <60mL/min): not established.

    Lyrica Oral Solution Contraindications

    Not Applicable

    Lyrica Oral Solution Boxed Warnings

    Not Applicable

    Lyrica Oral Solution Warnings/Precautions

    Warnings/Precautions

    Discontinue if angioedema, hypersensitivity reactions, myopathy or markedly elevated creatine kinase levels occur. Monitor for new or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood/behavior. Underlying respiratory depression; monitor and consider initiating at a low dose. CHF (w. NYHA Class III/IV status). Ocular conditions. Diabetes (monitor skin integrity). Avoid abrupt cessation (taper over ≥1 week). Pregnancy. Nursing mothers: not recommended.

    Lyrica Oral Solution Pharmacokinetics

    Absorption

    Peak plasma concentration: 1.5 hours (capsules). Oral bioavailability: ≥90%. Steady state: achieved within 24–48 hours.

    Distribution

    Apparent volume of distribution: ~0.5 L/kg.

    Elimination

    Renal (90%). Half-life: 6.3 hours.

    Lyrica Oral Solution Interactions

    Interactions

    Increased risk for serious respiratory depression when concomitant CNS depressants, opioids. Potentiates CNS depression with alcohol, other CNS depressants. Additive edema, weight gain with thiazolidinediones. Increased risk of angioedema with concomitant ACEIs.

    Lyrica Oral Solution Adverse Reactions

    Adverse Reactions

    Dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, thinking abnormal (primarily difficulty with concentration/attention); elevated creatine kinase, decreased platelets, PR prolongation, male-mediated teratogenicity; may be tumorigenic. Also in children: increased appetite.

    Lyrica Oral Solution Clinical Trials

    See Literature

    Lyrica Oral Solution Note

    Notes

    Register patients in North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling (888) 233-2334.

    Lyrica Oral Solution Patient Counseling

    See Literature

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