Paxil Suspension

— 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

    • Paxil Suspension Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Paroxetine (as HCl) 10mg/5mL; orange-flavored liq.

    Pharmacological Class

    SSRI.

    See Also

    How Supplied

    CR—30; Tabs—30; Susp—250mL

    Manufacturer

    Apotex Corp.

    Generic Availability

    YES

    Mechanism of Action

    The mechanism of action of paroxetine in the treatment of MDD, SAD, OCD, PD, GAD, and PTSD 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-hydroxy-tryptamine, 5-HT).

    Paxil Suspension Indications

    Indications

    Panic disorder (PD). Social anxiety disorder (SAD). Obsessive-compulsive disorder (OCD). Generalized anxiety disorder (GAD). Posttraumatic stress disorder (PTSD).

    Paxil Suspension Dosage and Administration

    Adult

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

    Children

    Not established.

    Paxil Suspension Contraindications

    Contraindications

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

    Paxil Suspension Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Paxil Suspension 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. Cardiac disease. Angle-closure glaucoma. Volume-depleted. Hyponatremia (esp. in elderly). Sexual dysfunction. Write ℞ for smallest practical amount. Avoid abrupt cessation; reduce dose gradually. Reevaluate periodically. Elderly. Labor & delivery. Pregnancy (during 3rd trimester; see full labeling for effects on neonates). Nursing mothers.

    Paxil Suspension Pharmacokinetics

    Elimination

    Renal, fecal.

    Paxil Suspension 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). Avoid alcohol. 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. Monitor digoxin, phenytoin, phenobarbital, theophylline, warfarin. Antagonized by fosamprenavir/ritonavir. Hormonal contraceptives and PMDD treatment: see full labeling.

    Paxil Suspension Adverse Reactions

    Adverse Reactions

    Abnormal ejaculation, headache, nausea, somnolence, diarrhea, asthenia, dizziness, sweating, constipation, decreased appetite, insomnia, infection, decreased libido, tremor, akathisia, dry mouth, genital disorder, abnormal vision, impotence, abnormal bleeding, yawn, others; discontinuation syndrome (monitor).

    Paxil Suspension Clinical Trials

    See Literature

    Paxil Suspension Note

    Not Applicable

    Paxil Suspension Patient Counseling

    See Literature

    Paxil Suspension Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Paroxetine (as HCl) 10mg/5mL; orange-flavored liq.

    Pharmacological Class

    SSRI.

    See Also

    How Supplied

    CR—30; Tabs—30; Susp—250mL

    Manufacturer

    Apotex Corp.

    Generic Availability

    YES

    Mechanism of Action

    The mechanism of action of paroxetine in the treatment of MDD, SAD, OCD, PD, GAD, and PTSD 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-hydroxy-tryptamine, 5-HT).

    Paxil Suspension Indications

    Indications

    Major depressive disorder (MDD).

    Paxil Suspension 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, debilitated, severe hepatic or renal impairment: initially 10mg/day; max 40mg/day.

    Children

    Not established.

    Paxil Suspension Contraindications

    Contraindications

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

    Paxil Suspension Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Paxil Suspension 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. Cardiac disease. Angle-closure glaucoma. Volume-depleted. Hyponatremia (esp. in elderly). Sexual dysfunction. Write ℞ for smallest practical amount. Avoid abrupt cessation; reduce dose gradually. Reevaluate periodically. Elderly. Labor & delivery. Pregnancy (during 3rd trimester; see full labeling for effects on neonates). Nursing mothers.

    Paxil Suspension Pharmacokinetics

    Elimination

    Renal, fecal.

    Paxil Suspension 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). Avoid alcohol. 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. Monitor digoxin, phenytoin, phenobarbital, theophylline, warfarin. Antagonized by fosamprenavir/ritonavir. Hormonal contraceptives and PMDD treatment: see full labeling.

    Paxil Suspension Adverse Reactions

    Adverse Reactions

    Abnormal ejaculation, headache, nausea, somnolence, diarrhea, asthenia, dizziness, sweating, constipation, decreased appetite, insomnia, infection, decreased libido, tremor, akathisia, dry mouth, genital disorder, abnormal vision, impotence, abnormal bleeding, yawn, others; discontinuation syndrome (monitor).

    Paxil Suspension Clinical Trials

    See Literature

    Paxil Suspension Note

    Not Applicable

    Paxil Suspension Patient Counseling

    See Literature

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