Generic Name and Formulations:
Paroxetine (as HCl) 12.5mg, 25mg, 37.5mg; controlled-release e-c tabs.
Company:
Apotex Corp
Indications for PAXIL CR:
Panic disorder. Social anxiety disorder.
Adult:
Swallow whole. Give once daily, usually in the AM, adjust by 12.5mg/day at 1-week intervals. Panic disorder: initially 12.5mg/day; max 75mg/day. Social anxiety disorder: 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.
Contraindications:
Concomitant pimozide, linezolid, IV methylene blue, thioridazine. During or within 14 days of MAOIs.
Warnings/Precautions:
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Screen for bipolar disorder. Monitor for serotonin syndrome or neuroleptic malignant syndrome-like signs and symptoms; discontinue if occurs. History of seizures (discontinue if occurs), mania/hypomania. Conditions that affect metabolism or hemodynamic response. Cardiac disease. ECT. Angle-closure glaucoma. Write ℞ for smallest practical amount. Avoid abrupt cessation; reduce dose gradually. Reeva luate periodically. Elderly. Labor & delivery. Pregnancy (Cat.D); avoid use. Nursing mothers.
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, 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, warfarin, or others that affect coagulation. Potentiated by cimetidine. Antagonized by fosamprenavir/ritonavir. May affect, or be affected by, drugs metabolized by CYP2D6, including tricyclic antidepressants, fluoxetine, phenothiazines, risperidone, atomoxetine, tamoxifen, Class 1C antiarrhythmics, quinidine. Monitor digoxin, phenytoin, phenobarbital, theophylline, warfarin. Reduce procyclidine dose if anticholinergic effects occur. Hormonal contraceptives and PMDD treatment: see full labeling.
See Also:
PAXIL
PAXIL SUSPENSION
Pharmacological Class:
SSRI.
Adverse Reactions:
Nausea, diarrhea, asthenia, dizziness, somnolence, sweating, decreased appetite, insomnia, nervousness, headache, decreased libido, tremor, akathisia, dry mouth, abnormal ejaculation, genital disorders, impotence, hyponatremia, abnormal bleeding, others; serious discontinuation symptoms (monitor); rare: neuroleptic malignant syndrome.
How Supplied:
CR—30; Tabs—30; Susp—250mL
Indications for PAXIL CR:
Major Depressive Disorder (MDD). Premenstrual dysphoric disorder (PMDD).
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.
Contraindications:
Concomitant pimozide, linezolid, IV methylene blue, thioridazine. During or within 14 days of MAOIs.
Warnings/Precautions:
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Screen for bipolar disorder. Monitor for serotonin syndrome or neuroleptic malignant syndrome-like signs and symptoms; discontinue if occurs. History of seizures (discontinue if occurs), mania/hypomania. Conditions that affect metabolism or hemodynamic response. Cardiac disease. ECT. Angle-closure glaucoma. Write ℞ for smallest practical amount. Avoid abrupt cessation; reduce dose gradually. Reeva luate periodically. Elderly. Labor & delivery. Pregnancy (Cat.D); avoid use. Nursing mothers.
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, 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, warfarin, or others that affect coagulation. Potentiated by cimetidine. Antagonized by fosamprenavir/ritonavir. May affect, or be affected by, drugs metabolized by CYP2D6, including tricyclic antidepressants, fluoxetine, phenothiazines, risperidone, atomoxetine, tamoxifen, Class 1C antiarrhythmics, quinidine. Monitor digoxin, phenytoin, phenobarbital, theophylline, warfarin. Reduce procyclidine dose if anticholinergic effects occur. Hormonal contraceptives and PMDD treatment: see full labeling.
See Also:
PAXIL
PAXIL SUSPENSION
Pharmacological Class:
SSRI.
Adverse Reactions:
Nausea, diarrhea, asthenia, dizziness, somnolence, sweating, decreased appetite, insomnia, nervousness, headache, decreased libido, tremor, akathisia, dry mouth, abnormal ejaculation, genital disorders, impotence, hyponatremia, abnormal bleeding, others; serious discontinuation symptoms (monitor); rare: neuroleptic malignant syndrome.
How Supplied:
CR—30; Tabs—30; Susp—250mL
