Paxil Cr

— 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 Cr Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Paroxetine (as HCl) 12.5mg, 25mg, 37.5mg; extended-release tabs.

    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 Cr Indications

    Indications

    Panic disorder (PD). Social anxiety disorder (SAD).

    Paxil Cr Dosage and Administration

    Adult

    Swallow whole. Give once daily, usually in the AM, adjust by 12.5mg/day at 1-week intervals. PD: initially 12.5mg/day; max 75mg/day. SAD: initially 12.5mg/day; max 37.5mg/day. Elderly, debilitated, severe hepatic or renal impairment: initially 12.5mg once daily; max 50mg/day.

    Children

    Not established.

    Paxil Cr Contraindications

    Contraindications

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

    Paxil Cr Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Paxil Cr 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 Cr Pharmacokinetics

    Elimination

    Renal, fecal.

    Paxil Cr 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 Cr 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 Cr Clinical Trials

    See Literature

    Paxil Cr Note

    Not Applicable

    Paxil Cr Patient Counseling

    See Literature

    Paxil Cr Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Paroxetine (as HCl) 12.5mg, 25mg, 37.5mg; extended-release tabs.

    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 Cr Indications

    Indications

    Major depressive disorder (MDD). Premenstrual dysphoric disorder (PMDD).

    Paxil Cr Dosage and Administration

    Adult

    Swallow whole. Give once daily, usually in the AM, adjust by 12.5mg/day at 1-week intervals. MDD: initially 25mg/day; max 62.5mg/day. PMDD: Give daily throughout menstrual cycle or intermittently (start 14 days before expected menses onset through 1st full day of menses): initially 12.5mg/day; usual max 25mg/day. Elderly, debilitated, severe hepatic or renal impairment: initially 12.5mg/day; max 50mg/day.

    Children

    Not established.

    Paxil Cr Contraindications

    Contraindications

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

    Paxil Cr Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Paxil Cr 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 Cr Pharmacokinetics

    Elimination

    Renal, fecal.

    Paxil Cr 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 Cr 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 Cr Clinical Trials

    See Literature

    Paxil Cr Note

    Not Applicable

    Paxil Cr Patient Counseling

    See Literature

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