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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
Generic Availability
YES
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. 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. Neonates. Pregnancy (Cat.D); avoid use. 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, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, 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 NSAIDs, aspirin, clopidogrel, 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
Generic Availability
YES
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. 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. Neonates. Pregnancy (Cat.D); avoid use. 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, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, 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 NSAIDs, aspirin, clopidogrel, 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
