No

Antidepressant, Selective Serotonin Reuptake Inhibitor

Treatment of depression; treatment of panic disorder with or without agoraphobia; obsessive-compulsive disorder; social anxiety disorder (social phobia)

C

Hypersensitivity to paroxetine; use of MAO inhibitors or within 14 days

Potential for severe reaction when used with MAO inhibitors - serotonin syndrome (hyperthermia, muscular rigidity, mental status changes/agitation, autonomic instability) may occur. May precipitate a shift to mania or hypomania in patients with bipolar disease. Has a low potential to impair cognitive or motor performance - caution operating hazardous machinery or driving. Low potential for sedation or anticholinergic effects relative to cyclic antidepressants. Use caution in patients with depression, particularly if suicidal risk may be present. Use caution in patients with a previous seizure disorder or condition predisposing to seizures such as brain damage, alcoholism, or concurrent therapy with other drugs which lower the seizure threshold. Use with caution in patients with hepatic or dysfunction and in elderly patients. May cause hyponatremia/SIADH. Use with caution in patients at risk of bleeding or receiving anticoagulant therapy - may cause impairment in platelet aggregation. Use with caution in patients with renal insufficiency or other concurrent illness (due to limited experience). May cause or exacerbate sexual dysfunction.

>10%:

Central nervous system: Headache, somnolence, dizziness, insomnia

Gastrointestinal: Nausea, xerostomia, constipation, diarrhea

Genitourinary: Ejaculatory disturbances

Neuromuscular & skeletal: Weakness

Miscellaneous: Diaphoresis

1% to 10%:

Cardiovascular: Palpitations, vasodilation, postural hypotension

Central nervous system: Nervousness, anxiety, yawning, abnormal dreams

Dermatologic: Rash

Endocrine & metabolic: Decreased libido, delayed ejaculation

Gastrointestinal: Anorexia, flatulence, vomiting, dyspepsia, taste perversion

Genitourinary: Urinary frequency, impotence

Neuromuscular & skeletal: Tremor, paresthesia, myopathy, myalgia

<1%: Bradycardia, hypotension, migraine, akinesia, mania, EPS, alopecia, acne, amenorrhea, colitis, anemia, leukopenia, arthritis, eye pain, ear pain, asthma, bruxism, thirst

Symptoms of overdose include nausea, vomiting, drowsiness, sinus tachycardia, and dilated pupils

There are no specific antidotes, following attempts at decontamination, treatment is supportive and symptomatic; forced diuresis, dialysis, and hemoperfusion are unlikely to be beneficial.

CYP2D6 enzyme substrate (minor); CYP2D6 and 1A2 enzyme inhibitor, and CYP3A3/4 enzyme inhibitor (weak)

Paroxetine may cause hyponatremia. Additive hyponatremic effects may be seen with combined use of a loop diuretic (bumetanide, furosemide, torsemide); monitor for hyponatremia

Paroxetine inhibits the reuptake of serotonin. Combined use with a serotonin agonist (buspirone) may cause serotonin syndrome

Paroxetine inhibits the metabolism of dextromethorphan; visual hallucinations occurred in a patient receiving this combination; monitor for serotonin syndrome

Paroxetine may inhibit the metabolism of haloperidol and cause extrapyramidal symptoms (EPS); monitor patients for EPS if combination is utilized

Paroxetine should not be used with nonselective MAOIs (isocarboxazid, phenelzine). Fatal reactions have been reported. Wait two weeks after stopping fluoxetine before starting an MAOI and two weeks after stopping an MAOI before starting fluoxetine.

Paroxetine inhibits the reuptake of serotonin; combined use with other drugs which inhibit the reuptake (nefazodone, sibutramine) may cause serotonin syndrome. Monitor patient for altered response with nefazodone; avoid sibutramine combination.

Paroxetine has been reported to cause mania or hypertension when combined with selegiline; this combination is best avoided

Paroxetine combined with tramadol (serotonergic effects) may cause serotonin syndrome; monitor

Paroxetine may alter the hypoprothombinemic response to warfarin; monitor

Cimetidine may reduce the first-pass metabolism of paroxetine resulting in elevated paroxetine serum concentrations; consider an alternative H₂ antagonist

Paroxetine is a selective serotonin reuptake inhibitor, chemically unrelated to tricyclic, tetracyclic, or other antidepressants; presumably, the inhibition of serotonin reuptake from brain synapse stimulated serotonin activity in the brain

Steady-state: ~10 days; therapeutic effects: >2 weeks

Metabolism: Extensive following absorption by cytochrome P-450 enzymes

Half-life: 21 hours

Elimination: Metabolites are excreted in bile and urine

Adults: Oral:

Paxil® CR™: Initial: 25 mg once daily; may be increased in 12.5 mg increments at intervals of at least 1 week (range: 26-62.5 mg)

Panic disorder and obsessive compulsive disorder: Recommended average daily dose: 40 mg, this dosage should be given after an adequate trial on 20 mg/day and then titrating upward

Social anxiety disorder: 20 mg/day

Hepatic and renal function tests, blood pressure, heart rate

LFTs

Although caution should be used in patients taking tricyclic antidepressants, no interactions have been reported with vasoconstrictor and paroxetine, a nontricyclic antidepressant which acts to increase serotonin

>10% of patients experience dry mouth; prolonged use of paroxetine may decrease or inhibit salivary flow; normal salivary flow will resume with cessation of drug therapy

Take exactly as directed (do not increase dose or frequency); may take 2-3 weeks to achieve desired results; may cause physical and/or psychological dependence. Take in the morning to reduce the incidence of insomnia. Avoid excessive alcohol, caffeine, and other prescription or OTC medications not approved by prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience drowsiness, dizziness, or lightheadedness (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, anorexia, or dry mouth (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); or orthostatic hypotension (use caution when climbing stairs or changing position from lying or sitting to standing). Report persistent insomnia or excessive daytime sedation; muscle cramping, tremors, weakness, or change in gait; chest pain, palpitations, or rapid heartbeat; vision changes or eye pain; difficulty breathing or breathlessness; abdominal pain or blood in stool; or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Breast-feeding is not recommended.

Monitor hepatic and renal function tests, blood pressure, heart rate

Suspension, oral: 10 mg/5 mL

Tablet: 10 mg, 20 mg, 30 mg, 40 mg

Tablet, controlled release (Paxil® CR™): 12.5 mg, 25 mg

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