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PAXIL SUSPENSION
Anxiety/OCD
Mood disorders
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Drug Name:

PAXIL SUSPENSION Rx

Generic Name and Formulations:
Paroxetine (as HCl) 10mg/5mL; orange-flavored liq.

Company:
Apotex Corp.

Therapeutic Use:

Indications for PAXIL SUSPENSION:

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

Adult:

Give once daily, usually in the AM, adjust by 10mg/day at 1-week intervals. Panic disorder: initially 10mg/day; usual 40mg/day; max 60mg/day. Social anxiety disorder: 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.

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. Reevaluate 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, 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, 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 CR

PAXIL

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 SUSPENSION:

Major Depressive Disorder (MDD).

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.

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. Reevaluate 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, 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, 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 CR

PAXIL

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

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