Pexeva

— THERAPEUTIC CATEGORIES —
  • Anxiety/OCD
  • Mood 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

    • Pexeva Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Paroxetine (as mesylate) 10mg, 20mg+, 30mg, 40mg; tabs; +scored.

    Pharmacological Class

    SSRI.

    How Supplied

    Tabs—30

    Manufacturer

    Sebela Pharmaceuticals Inc.

    Generic Availability

    NO

    Mechanism of Action

    The mechanism of action of paroxetine in the treatment of major depressive disorder, obsessive compulsive disorder, panic disorder, and general anxiety disorder is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-HT).

    Pexeva Indications

    Indications

    Panic disorder (PD). Obsessive-compulsive disorder (OCD). Generalized anxiety disorder (GAD).

    Pexeva Dosage and Administration

    Adult

    Give once daily, usually in the AM; adjust by 10mg/day at 1-week intervals. PD: initially 10mg/day; max 60mg/day. OCD: initially 20mg/day; max 60mg/day. GAD: initially 20mg/day; max 50mg/day. Elderly, severe renal or severe hepatic impairment: initially 10mg/day; max 40mg/day.

    Children

    Not established.

    Pexeva Contraindications

    Contraindications

    Concomitant pimozide, thioridazine. During or within 14 days of MAOIs (including linezolid, IV methylene blue).

    Pexeva Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Pexeva Warnings/Precautions

    Warnings/Precautions

    Increased risk of suicidal thoughts and behavior in children and young adults; monitor all patients for clinical worsening or unusual changes. Monitor for serotonin syndrome; discontinue and treat if occurs. Screen for bipolar disorder, mania, or hypomania. Seizure disorder. Risk for bleeding events. Angle-closure glaucoma. Avoid in untreated anatomically narrow angles. Volume-depleted. Hyponatremia (esp. in elderly). Bone fracture risk. Sexual dysfunction. Write ℞ for the smallest practical amount. Avoid abrupt cessation; reduce dose gradually. Reevaluate periodically. Renal and/or hepatic impairment. Elderly. Labor & delivery. Pregnancy (during 3rd trimester; see full labeling for effects on neonates). Nursing mothers.

    Pexeva Pharmacokinetics

    Absorption

    Paroxetine mesylate is completely absorbed after oral dosing.

    Distribution

    Paroxetine distributes throughout the body, including the CNS, with only 1% remaining in the plasma. Plasma protein bound: ~95% and 93% at 100 ng/mL and 400 ng/mL, respectively.

    Metabolism

    CYP2D6.

    Elimination

    Renal (64%), fecal (36%). Half-life: 15–20 hours.

    Pexeva Interactions

    Interactions

    See Contraindications. Do not start MAOI until at least 2 weeks after discontinuing paroxetine. Increased risk of serotonin syndrome with other serotonergic drugs (eg, other SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Potentiation with other protein bound drugs. Increased risk of bleeding with aspirin, NSAIDs, clopidogrel, heparin, warfarin, or others that affect coagulation. May affect, or be affected by, drugs metabolized by CYP2D6 (eg, propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone). May reduce effects of tamoxifen; consider alternative antidepressant. Antagonized by fosamprenavir/ritonavir.

    Pexeva Adverse Reactions

    Adverse Reactions

    Asthenia, sweating, nausea, decreased appetite, dry mouth, constipation, somnolence, dizziness, insomnia, tremor, nervousness, libido decreased, female genital disorders, impotence, ejaculatory disturbance, other male genital disorders, orgasmic disturbance, infection; discontinuation syndrome.

    Pexeva Clinical Trials

    See Literature

    Pexeva Note

    Not Applicable

    Pexeva Patient Counseling

    See Literature

    Pexeva Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Paroxetine (as mesylate) 10mg, 20mg+, 30mg, 40mg; tabs; +scored.

    Pharmacological Class

    SSRI.

    How Supplied

    Tabs—30

    Manufacturer

    Sebela Pharmaceuticals Inc.

    Generic Availability

    NO

    Mechanism of Action

    The mechanism of action of paroxetine in the treatment of major depressive disorder, obsessive compulsive disorder, panic disorder, and general anxiety disorder is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-HT).

    Pexeva Indications

    Indications

    Major Depressive Disorder (MDD).

    Pexeva Dosage and Administration

    Adult

    Give once daily, usually in the AM; adjust by 10mg/day at 1-week intervals. Initially 20mg/day; max 50mg/day. Elderly, severe renal or severe hepatic impairment: initially 10mg/day; max 40mg/day.

    Children

    Not established.

    Pexeva Contraindications

    Contraindications

    Concomitant pimozide, thioridazine. During or within 14 days of MAOIs (including linezolid, IV methylene blue).

    Pexeva Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Pexeva Warnings/Precautions

    Warnings/Precautions

    Increased risk of suicidal thoughts and behavior in children and young adults; monitor all patients for clinical worsening or unusual changes. Monitor for serotonin syndrome; discontinue and treat if occurs. Screen for bipolar disorder, mania, or hypomania. Seizure disorder. Risk for bleeding events. Angle-closure glaucoma. Avoid in untreated anatomically narrow angles. Volume-depleted. Hyponatremia (esp. in elderly). Bone fracture risk. Sexual dysfunction. Write ℞ for the smallest practical amount. Avoid abrupt cessation; reduce dose gradually. Reevaluate periodically. Renal and/or hepatic impairment. Elderly. Labor & delivery. Pregnancy (during 3rd trimester; see full labeling for effects on neonates). Nursing mothers.

    Pexeva Pharmacokinetics

    Absorption

    Paroxetine mesylate is completely absorbed after oral dosing.

    Distribution

    Paroxetine distributes throughout the body, including the CNS, with only 1% remaining in the plasma. Plasma protein bound: ~95% and 93% at 100 ng/mL and 400 ng/mL, respectively.

    Metabolism

    CYP2D6.

    Elimination

    Renal (64%), fecal (36%). Half-life: 15–20 hours.

    Pexeva Interactions

    Interactions

    See Contraindications. Do not start MAOI until at least 2 weeks after discontinuing paroxetine. Increased risk of serotonin syndrome with other serotonergic drugs (eg, other SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Potentiation with other protein bound drugs. Increased risk of bleeding with aspirin, NSAIDs, clopidogrel, heparin, warfarin, or others that affect coagulation. May affect, or be affected by, drugs metabolized by CYP2D6 (eg, propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone). May reduce effects of tamoxifen; consider alternative antidepressant. Antagonized by fosamprenavir/ritonavir.

    Pexeva Adverse Reactions

    Adverse Reactions

    Asthenia, sweating, nausea, decreased appetite, dry mouth, constipation, somnolence, dizziness, insomnia, tremor, nervousness, libido decreased, female genital disorders, impotence, ejaculatory disturbance, other male genital disorders, orgasmic disturbance, infection; discontinuation syndrome.

    Pexeva Clinical Trials

    See Literature

    Pexeva Note

    Not Applicable

    Pexeva Patient Counseling

    See Literature

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