PARoxetine (Monograph)

Brand name: Paxil
Drug class: Selective Serotonin-reuptake Inhibitors
- Selective Serotonin-reuptake Inhibitors
- Serotonin-reuptake Inhibitors
- SSRIs
VA class: CN609
Chemical name: trans-(-)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride hemihydrate
Molecular formula: C₁₉H₂₀FNO₃•HCl•½H₂O
CAS number: 110429-35-1

Medically reviewed by Drugs.com on Apr 4, 2024. Written by ASHP.

Warning

Antidepressants increased risk of suicidal thinking and behavior (suicidality) compared with placebo in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.³¹⁴ ³¹⁵ ⁶¹¹ Paroxetine is not approved for use in pediatric patients.⁶¹¹ (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and was reduced in adults ≥65 years of age with antidepressants compared with placebo.³¹⁴ ³¹⁵ ⁶¹¹
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.³¹⁴ ³¹⁵ ³²⁰ ⁶¹¹
Appropriately monitor and closely observe all patients who are started on paroxetine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.³¹⁴ ³¹⁵ ³²⁰ ⁶¹¹ (See Worsening of Depression and Suicidality Risk under Cautions.)

Introduction

Antidepressant; selective serotonin-reuptake inhibitor (SSRI).¹ ² ⁵ ⁶

Uses for PARoxetine

Major Depressive Disorder

Management of major depressive disorder.¹ ⁵ ⁸ ⁹ ¹⁰ ¹¹ ¹² ¹³ ¹⁴ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ¹⁹ ²⁰ ²¹ ²⁶ ³⁰ ³⁹ ⁴² ⁷⁴ ⁷⁶ ¹³¹ ¹³² ¹³⁴ ¹³⁵ ¹⁵⁵

Efficacy in hospital settings not established.¹

Obsessive-Compulsive Disorder (OCD)

Management of OCD;¹ ⁴⁹ ⁵⁰ SSRIs reduce but do not completely eliminate obsessions and compulsions.¹

Panic Disorder

Management of panic disorder with or without agoraphobia.¹ ⁴⁸ ⁵³ ⁵⁴ ¹⁸⁰ ¹⁸⁶ ¹⁸⁷ ¹⁹⁰ ¹⁹² ²⁷²

Social Phobia

Management of social phobia (social anxiety disorder).¹ ¹⁵⁵ ¹⁵⁸ ¹⁵⁹ ¹⁶⁰ ¹⁶¹

Anxiety Disorders

Management of generalized anxiety disorder.¹

Posttraumatic Stress Disorder (PTSD)

Management of PTSD (alone or in combination with psychotherapy).¹ ¹⁶⁸ ²⁹⁶ ²⁹⁷ ²⁹⁸

Premenstrual Dysphoric Disorder (PMDD)

Management of PMDD.⁷⁹ ⁸⁰ ¹⁵⁵ ¹⁶²

Premature Ejaculation

Has been used for the management of premature ejaculation^{† [off-label]}.¹⁶⁹ ¹⁷⁰ ¹⁷¹ ¹⁷² ¹⁷³ ¹⁷⁴

Diabetic Neuropathy

Has been used for the management of diabetic neuropathy^{† [off-label]}.²⁴ ¹³⁶

Chronic Headache

Has been used for the management of chronic headache^{† [off-label]}.¹⁵⁵ ¹⁶³ ¹⁶⁴

PARoxetine Dosage and Administration

General

Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor intended to treat psychiatric disorders and initiation of paroxetine, and vice versa.⁶¹¹ (See Contraindications and Serotonin Syndrome under Cautions and also see Specific Drugs under Interactions.)
Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.³¹⁴ ³¹⁵ ³²⁰ ⁶¹¹ (See Worsening of Depression and Suicidality Risk under Cautions.)
Sustained therapy may be required;¹ ⁴² ⁵¹ ⁵² ¹⁰¹ ¹⁰² ¹⁰³ ¹⁰⁴ ¹²⁹ ¹³⁰ ¹³³ periodically reassess for need for continued therapy.¹
Avoid abrupt discontinuance of therapy;²⁴ ¹⁸⁴ ¹⁹⁷ ¹⁹⁸ ²⁰⁰ ²⁰⁴ to avoid withdrawal reactions, taper dosage gradually over a period of several weeks.¹⁸⁴ ¹⁹⁴ ¹⁹⁷ ¹⁹⁸ ²⁰⁰ (See Withdrawal of Therapy under Cautions.)

Administration

Oral Administration

Administer orally once daily (in the morning) without regard to meals;¹ ⁷ ⁸ ¹⁹ ⁹² ³¹² however, administration with food may minimize adverse GI effects.⁸ ¹⁹

Shake oral suspension well just prior to administration.¹

Swallow extended-release tablets whole; do not chew or crush.³⁰⁴

Dosage

Available as paroxetine hydrochloride; dosage expressed in terms of paroxetine.¹

Adults

Major Depressive Disorder

Oral

Conventional tablets or suspension: Initially, 20 mg once daily.¹ ³⁰⁴ If no improvement, dosage may be increased in 10-mg increments at weekly intervals.¹ ³⁰⁴

Extended-release tablets: Initially, 25 mg once daily.¹ ³⁰⁴ If no improvement, dosage may be increased in 12.5-mg increments at weekly intervals.¹ ³⁰⁴

Optimum duration not established; may require several months of therapy or longer.¹ ²² ⁴² ¹⁰¹ ¹⁰² ¹⁰³ ¹⁰⁴ ¹²⁹ ¹³⁰ ¹³³ ³⁰⁴ Antidepressant efficacy demonstrated for up to 1 year at mean dosage of 30 mg daily as conventional tablets or suspension, which corresponds to a 37.5 mg daily dosage as extended-release tablets.¹ ¹³³

Obsessive-Compulsive Disorder

Oral

Conventional tablets or suspension: Initially, 20 mg once daily.¹ If no improvement, dosage may be increased in 10-mg increments at weekly intervals, to 40 mg daily.¹

Optimum duration not established; efficacy has been demonstrated in a 6-month relapse prevention trial.¹ Obsessive-compulsive disorder is chronic and requires several months or longer of sustained therapy.¹ ⁵¹ ⁵² May continue therapy in responding patients,¹ ⁵¹ ⁵² but use lowest effective dosage and periodically reassess need for continued therapy.¹

Panic Disorder

Oral

Conventional tablets or suspension: Initially, 10 mg once daily.¹ ⁴⁸ If no improvement, dosage may be increased in 10-mg increments at weekly intervals, to 40 mg daily.¹ ⁴⁸

Extended-release tablets: Initially, 12.5 mg once daily.³¹² If no improvement, dosage may be increased in 12.5-mg increments at weekly intervals.³¹²

Optimum duration not established; efficacy demonstrated in a 3-month relapse prevention trial.¹ ⁴⁸ ⁵⁴ ¹⁸⁴ May continue therapy in responding patients,¹ ⁴⁸ ⁵⁴ ¹⁸⁴ but use lowest effective dosage and periodically reassess need for continued therapy.¹

Social Phobia

Oral

Conventional tablets or suspension: 20 mg once daily; no additional clinical benefit was observed with higher dosages.¹

Extended-release tablets: Initially, 12.5 mg once daily.³¹² If dosage is increased, use 12.5-mg increments at weekly intervals.³¹²

Long-term efficacy (>12 weeks) not demonstrated; may consider continuation in patient who responds, but use lowest effective dosage and periodically reassess need for continued therapy.¹

Anxiety Disorders

Oral

Conventional tablets or suspension: Initially, 20 mg daily; no additional clinical benefit was observed with higher dosages.¹ If needed, dosage may be increased in 10-mg increments at weekly intervals.¹

Optimum duration not established; efficacy has been demonstrated in a 24-week relapse prevention trial.¹ ³²¹ Generalized anxiety disorder is chronic.¹ ³²¹ May continue therapy in responding patients.¹ ³²¹ If used for extended periods, adjust dosage so that patients are maintained on lowest effective dosage and periodically reassess need for continued therapy.¹

Posttraumatic Stress Disorder

Oral

Conventional tablets or suspension: 20 mg daily; insufficient evidence to suggest greater clinical benefit with higher dosages.¹ If needed, dosage may be increased in 10-mg increments at weekly intervals.¹

Consider alternative therapy if patient fails to achieve ≥25% reduction in PTSD symptoms at week 8.³⁰⁰ If >75% reduction in PTSD symptoms and response maintained for ≥3 months, may consider up to 24 months of drug therapy.³⁰⁰ If used for extended periods, adjust dosage so that patients are maintained on lowest effective dosage and periodically reassess need for continued therapy.¹

Premenstrual Dysphoric Disorder

Oral

Conventional tablets or suspension^{† [off-label]}: 5–30 mg daily.⁷⁹

Extended-release tablets: Initially, 12.5 mg once daily; may be administered daily throughout menstrual cycle or only during luteal phase.³¹² Dosage may be increased in intervals of ≥1 week.³¹² Dosages of 12.5–25 mg were effective in clinical studies.³¹²

Premature Ejaculation† [off-label]

Oral

Conventional tablets or suspension: 10–40 mg once daily.¹⁷² ¹⁷³ ²⁷⁹ ²⁸⁰ ²⁸¹ Alternatively, 20 mg taken 3–4 hours before planned intercourse on an “as needed” basis.²⁸⁰ ²⁸¹

Diabetic Neuropathy†

Oral

Conventional tablets or suspension: 40 mg daily.²⁴ ¹³⁶

Chronic Headache†

Oral

Conventional tablets or suspension: 10–50 mg daily for 3–9 months.¹⁶⁴

Prescribing Limits

Adults

Major Depressive Disorder

Oral

Conventional tablets or suspension: Maximum 50 mg daily.

Extended-release tablets: 62.5 mg daily.¹ ³⁰⁴

Obsessive-Compulsive Disorder

Oral

Conventional tablets or suspension: Maximum 60 mg daily.¹

Panic Disorder

Oral

Conventional tablets or suspension: Maximum 60 mg daily.¹

Extended-release tablets: 75 mg daily.³¹²

Social Phobia

Oral

Extended-release tablets: 37.5 mg daily.³¹²

Special Populations

Hepatic Impairment

Oral

In patients with severe hepatic impairment, an initial dosage of 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets).¹ ³⁰⁴ If no clinical improvement is apparent, dosage may be titrated with caution up to a maximum of 40 mg daily (for conventional tablets or suspension) or 50 mg (for extended-release tablets).¹ ⁹⁸ ⁹⁹ ³⁰⁴

Renal Impairment

Oral

In patients with severe renal impairment, an initial dosage of 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets).¹ ³⁰⁴ If no clinical improvement is apparent, dosage may be titrated with caution up to a maximum of 40 mg daily (for conventional tablets or suspension) or 50 mg (for extended-release tablets).¹ ⁹⁸ ⁹⁹ ³⁰⁴

Geriatric or Debilitated Patients

Initially, 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets); if no clinical improvement is apparent, dosage may be titrated up to a maximum of 40 mg daily (as conventional tablets or suspension) or 50 mg daily (as extended-release tablets).¹ ⁹⁵ ³⁰⁴

Cautions for PARoxetine

Contraindications

Paroxetine is contraindicated in patients who are currently receiving or have recently (i.e., within 2 weeks) received therapy with an MAO inhibitor intended to treat psychiatric disorders.⁶¹¹ Conversely, MAO inhibitors intended to treat psychiatric disorders are contraindicated within 2 weeks of paroxetine discontinuance.⁶¹¹ (See Serotonin Syndrome under Cautions and also see Specific Drugs under Interactions.)
Initiation of paroxetine is contraindicated in patients receiving MAO inhibitors such as linezolid or IV methylene blue.⁶¹¹ (See Specific Drugs under Interactions.)
Concurrent therapy with thioridazine.¹ (See Drug Interaction with Thioridazine under Warnings.)
Concurrent pimozide therapy.¹ ³¹² (See Interactions.)
Known hypersensitivity to paroxetine or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.³¹⁴ ³¹⁵ ³²⁰ ⁶¹¹ However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.³¹⁴ ³¹⁵ ³²⁰ ⁶¹¹

Appropriately monitor and closely observe patients receiving paroxetine for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.³¹⁴ ³¹⁵ ³²⁰ ⁶¹¹ (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.³¹⁴ ³²⁰ ⁶¹¹ Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.³¹⁴ ³¹⁵ ³²⁰ ⁶¹¹ If decision is made to discontinue therapy, taper paroxetine dosage as rapidly as is feasible but consider risks of abrupt discontinuance.³¹⁴ ⁶¹¹ (See General under Dosage and Administration.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.³¹⁴ ⁶¹¹

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.³¹⁴ ⁶¹¹

Bipolar Disorder

May unmask bipolar disorder.¹ ³¹² ³¹⁴ (See Activation of Mania or Hypomania under Cautions.) Paroxetine is not approved for use in treating bipolar depression.¹ ³¹²

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.¹ ³¹² ³¹⁴

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported with SSRIs and SNRIs alone, but particularly during concurrent therapy with other serotonergic drugs (e.g., 5-HT₁ receptor agonists [“triptans”], TCAs, amphetamines, buspirone, fentanyl, lithium, tramadol, tryptophan, St. John's wort [Hypericum perforatum]) and with drugs that impair the metabolism of serotonin (particularly MAO inhibitors, both those used to treat psychiatric disorders and others, such as linezolid and methylene blue).⁶¹¹ (See Interactions.)

Symptoms of serotonin syndrome may include mental status changes (e.g., agitation, hallucinations, delirium, coma), autonomic instability (e.g., tachycardia, labile BP, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or GI symptoms (e.g., nausea, vomiting, diarrhea).⁶¹¹

Paroxetine is contraindicated in patients who are currently receiving or have recently (i.e., within 2 weeks) received therapy with MAO inhibitors intended to treat psychiatric disorders.⁶¹¹ Do not initiate paroxetine in patients treated with other MAO inhibitors such as linezolid or IV methylene blue.⁶¹¹ (See Specific Drugs under Interactions.)

If concurrent therapy with other serotonergic drugs is clinically warranted, advise patient of potentially increased risk for serotonin syndrome, particularly during initiation of therapy and dosage increases.⁶¹¹

Monitor patients receiving paroxetine for the development of serotonin syndrome.⁶¹¹ If manifestations occur, immediately discontinue paroxetine and any concurrently administered serotonergic agents and initiate supportive and symptomatic treatment.⁶¹¹

Drug Interaction with Thioridazine

May inhibit CYP2D6, resulting in increased risk of QT-interval prolongation and/or ventricular tachycardia of the torsades de pointes type associated with elevated plasma concentrations of thioridazine.¹ (See Contraindications.)

Fetal/Neonatal Morbidity and Mortality

May increase risk of fetal defects (e.g., cardiovascular malformations, principally ventricular and atrial septal defects; other major congenital malformations) when administered to pregnant women.³²⁶ ³³³ ³³⁷ ³³⁸ ³⁵⁸ ^a ^c

If a patient becomes pregnant during treatment, advise patient of the potential hazard to the fetus.³³⁷ ³³⁸ ^a ^c Unless the potential benefits to the mother justify continuing treatment, consider discontinuing paroxetine therapy or switching to another antidepressant.³³⁷ ³³⁸ ^a ^c (See General under Dosage and Administration.) For women who intend to become pregnant or are in their first trimester of pregnancy, initiate paroxetine only after consideration of other available treatment options.³³⁷ ³³⁸ ^a ^c

Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care in neonates exposed to paroxetine, other SSRIs, or SNRIs late in the third trimester; may arise immediately upon delivery.¹ ³¹² ³²⁷ ³²⁸ ³²⁹ ³³⁰ ³³¹ ³³²

Conflicting findings from available studies evaluating possible risk of persistent pulmonary hypertension of the newborn (PPHN) following in utero exposure to SSRIs; currently unclear whether SSRI use during pregnancy can cause PPHN.³⁷⁰ ⁶⁰⁰ ⁶⁰¹ ⁶⁰² ⁶⁰³ ⁶⁰⁴ ⁶⁰⁵ ⁶⁰⁶ ⁶¹⁰ ⁶¹¹

Carefully consider both the potential risks and benefits of treatment when used during the third trimester of pregnancy.¹ ³¹² ³²⁶ ³²⁸ ³²⁹ ³³⁰ Be aware that in a longitudinal study involving women with a history of major depressive disorder who were euthymic while receiving antidepressant therapy at the beginning of pregnancy, women who discontinued antidepressant therapy during pregnancy were more likely to experience a relapse of depression than those who remained on antidepressant therapy.¹ ³¹²

Consult joint APA and ACOG guidelines (at [Web]) for additional information on management of depression in women prior to conception and during pregnancy, including treatment algorithms.⁶⁰⁰ ⁶⁰⁸

General Precautions

Activation of Mania or Hypomania

Possible activation of mania or hypomania.¹ ² Use with caution in patients with a history of mania.¹ ³¹² (See Bipolar Disorder under Cautions.)

Seizures

Seizures have been reported.¹ ² Limited experience with use of paroxetine in patients with a history of seizures; use with caution in such patients.¹ Discontinue if seizures occur.¹

Akathisia

Akathisia has been reported.¹ ²²⁶ ²²⁷ ³¹² Most likely to occur within the first few weeks of therapy.¹ ³¹²

Hyponatremia

May occur secondary to SIADH;²⁴ ²⁵ ²⁸ apparently reversible following discontinuance of the drug and/or fluid restriction.¹ ²² ²⁴ ²⁸ ²¹⁰ ²¹⁵ ²¹⁷ Occurs mainly in older patients¹ ²² ²⁴ ²⁵ ²⁸ and those receiving diuretics or otherwise volume depleted.¹ (See Geriatric Use under Cautions.)

Abnormal Bleeding

Possible increased risk of bleeding, including upper GI bleeding;¹ ³¹² ³²³ ³²⁴ ³²⁵ use with caution.^a

Concomitant use of an NSAIA (e.g., aspirin) or warfarin may potentiate such risk.¹ ⁶ ¹⁴⁷ ³¹² ³²³ ³²⁴ ³²⁵

Concomitant Disease

May be less cardiotoxic than most older antidepressant agents but experience is limited in patients with recent MI or unstable heart disease.¹ ² ¹⁸ ²⁴ ¹⁴⁵ Use with caution.¹ ⁹⁸ ⁹⁹ ¹⁴⁵ ²²⁵

May cause mydriasis.¹ ²⁹⁹ Use with caution in patients with angle-closure glaucoma.¹

Cognitive and Motor Performance

Does not appear to produce substantial cognitive or motor impairment,¹ ² ³ ¹⁸ ¹⁹ ²⁴ ⁶² ⁷² ⁷³ but patients should be cautioned to avoid activities requiring alertness or physical coordination until effects on individual are known.¹ ⁶²

Withdrawal of Therapy

Possible withdrawal reactions following abrupt discontinuance or intermittent noncompliance with therapy.¹ ²³ ²⁴ ³² ³³ ⁴⁶ ⁴⁷ ¹⁹⁶ ¹⁹⁷ ¹⁹⁸ ¹⁹⁹ ²⁰⁰ ²⁰¹ ²⁰² ²⁰³ ²⁰⁴ ²⁰⁵ ²⁰⁶ Avoid abrupt discontinuance of therapy;²⁴ ¹⁸⁴ ¹⁹⁷ ¹⁹⁸ ²⁰⁰ ²⁰⁴ taper dosage gradually over a period of several weeks.¹⁸⁴ ¹⁹⁴ ¹⁹⁷ ¹⁹⁸ ²⁰⁰

If intolerable symptoms occur, reinstitute at the previously prescribed dosage until such symptoms abate.¹ ³⁰⁴ Clinicians may resume dosage reductions at that time but at a more gradual rate.¹ ³⁰⁴

Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT have not been systematically evaluated.¹

Specific Populations

Pregnancy

See Fetal/Neonatal Morbidity and Mortality under Cautions.

Effect of paroxetine on labor and delivery unknown.¹ ³⁴³ However, there have been postmarketing reports of premature births in pregnant women who have received paroxetine or other SSRIs.¹ ³¹² ³⁴³

Lactation

Distributed into human milk;¹ ¹⁰⁰ use with caution.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹ ²⁷¹ ³¹²

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during the first few months of antidepressant treatment compared with placebo in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).³¹⁴ ³¹⁵ ³¹⁶ However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.³⁶⁸ No suicides occurred in these pediatric trials.³¹⁴ ³¹⁵ ³⁶⁸ ⁶¹¹

Carefully consider these findings when assessing potential benefits and risks of paroxetine in a child or adolescent for any clinical use.³¹⁴ ³¹⁵ ³²⁰ ³⁶⁸ ⁶¹¹ (See Suicidality in the Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

Possible decreased clearance; however, efficacy and adverse effects similar to those in younger adults.¹ ² ⁴ ⁷ ¹⁸ ²⁴ ⁸³ ⁹⁵ ⁹⁶ ⁹⁷ Initiate therapy at a lower dosage.¹ ⁸ ⁹⁵ (See Geriatric or Debilitated Patients under Dosage and Administration.)

May be more likely than younger patients to develop hyponatremia and transient SIADH.¹ ²² ²⁴ ²⁵ ²⁸ ²¹⁴ ²¹⁵ Periodically monitor serum sodium concentrations, especially during the first several months of therapy.¹⁸¹ ²¹⁷

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.³¹⁴ ³¹⁵ ⁶¹¹ (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Hepatic Impairment

Increased plasma concentrations¹ ⁴ ⁹⁸ ⁹⁹ and decreased clearance reported.¹ ¹³⁷ Use with caution; use at a reduced initial dosage if impairment is severe.¹ ⁹⁸ ⁹⁹ ¹⁴⁵ ²²⁵ (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Increased plasma concentrations¹ ⁴ ⁹⁸ ⁹⁹ and decreased clearance reported.¹ ¹³⁷ Use with caution; use at a reduced initial dosage if impairment is severe.¹ ⁹⁸ ⁹⁹ ¹⁴⁵ ²²⁵ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Nervous system effects (e.g., asthenia, somnolence, dizziness, insomnia, tremor, nervousness), GI effects (e.g., nausea, decreased appetite, constipation, dry mouth), impotence, ejaculatory dysfunction, female genital disorders (e.g., anorgasmia or difficulty reaching climax/orgasm), sweating.¹ ² ³ ²⁴ ⁷⁶

Drug Interactions

Metabolized partially by CYP2D6.¹ Inhibits the activity of CYP2D6 and to a lesser extent CYP3A4.¹ ⁹¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP2D6 or CYP3A4: possible increased plasma concentrations of the substrates.¹ ⁹¹ ²⁷⁷

Use with caution and consider reducing dosage of concomitantly administered CYP2D6 substrate, particularly those with a narrow therapeutic index, such as TCAs, class IC antiarrhythmics, and some phenothiazines.¹ ⁹¹ ²⁷⁷

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors or inducers of CYP isoenzymes (e.g., CYP2D6): potential pharmacokinetic interaction (altered paroxetine metabolism and plasma concentrations).^a

Drugs Associated with Serotonin Syndrome

Potentially life-threatening serotonin syndrome with other serotonergic drugs.⁶¹¹ If concomitant use of other serotonergic drugs with paroxetine is clinically warranted, advise patients of the increased risk for serotonin syndrome, particularly during treatment initiation and dosage increases.⁶¹¹

If serotonin syndrome occurs, immediately discontinue paroxetine and any concurrently administered serotonergic agents; initiate supportive and symptomatic treatment.⁶¹¹ (See Serotonin Syndrome under Cautions.)

Drugs Affecting Hemostasis

Potential pharmacologic interaction (increased risk of bleeding) with concomitant use of drugs that affect hemostasis.¹ ⁶ ¹⁴⁷ ³²³ ³¹² ³²⁴ ³²⁵ Use with caution.¹

Specific Drugs

Drug	Interaction	Comments
Alcohol	Does not potentiate cognitive and motor effects of alcohol;¹ ² ³ ⁶ ¹⁹ ²⁴ ¹⁴⁶ possible serotonergically mediated pharmacodynamic interaction in CNS¹⁴⁶	Avoid concomitant use¹
Amphetamines	Potentially life-threatening serotonin syndrome⁶¹¹	If concomitant use clinically warranted, advise patients of the increased risk for serotonin syndrome, particularly during treatment initiation and dosage increases⁶¹¹ If serotonin syndrome occurs, immediately discontinue paroxetine, the amphetamine, and any concurrently administered serotonergic agents; initiate supportive and symptomatic treatment⁶¹¹
Antacids	Pharmacokinetic interactions unlikely⁶ ¹⁹ ⁹²
Antiarrhythmic agents, class IC (e.g., encainide, flecainide, propafenone)	Possible inhibition of metabolism by paroxetine^a	Use caution^a
Antidepressants, other SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, sertraline) or SNRIs (e.g., desvenlafaxine, duloxetine, milnacipran, venlafaxine)	Potentially life-threatening serotonin syndrome⁶¹¹	If concomitant use clinically warranted, advise patients of the increased risk for serotonin syndrome, particularly during treatment initiation and dosage increases⁶¹¹ If serotonin syndrome occurs, immediately discontinue paroxetine, the SSRI or SNRI, and any concurrently administered serotonergic agents; initiate supportive and symptomatic treatment⁶¹¹
Antidepressants, tricyclics (TCAs) (e.g., desipramine, imipramine)	Increased peak plasma concentrations, AUC, and elimination half-life of TCA¹ Potentially life-threatening serotonin syndrome⁶¹¹	Use with caution¹ May need to monitor plasma tricyclic concentrations; consider reducing tricyclic dosage¹ If concomitant use clinically warranted, advise patients of the increased risk for serotonin syndrome, particularly during treatment initiation and dosage increases⁶¹¹ If serotonin syndrome occurs, immediately discontinue paroxetine, the TCA, and any concurrently administered serotonergic agents; initiate supportive and symptomatic treatment⁶¹¹
Atomoxetine	Increased peak plasma concentrations and AUCs of atomoxetine¹ ³¹² ³³⁵ ³³⁶ Pharmacokinetics of paroxetine not affected³³⁵	Consider initiating atomoxetine in a reduced dosage and adjust atomoxetine dosage if necessary¹ ³¹²
Benzodiazepines (e.g., diazepam, lorazepam, oxazepam)	Pharmacokinetic or pharmacologic interactions unlikely¹ ⁶ ¹⁴⁷ ¹⁴⁸
Buspirone	Potentially life-threatening serotonin syndrome⁶¹¹	If concomitant use clinically warranted, advise patients of the increased risk for serotonin syndrome, particularly during treatment initiation and dosage increases⁶¹¹ If serotonin syndrome occurs, immediately discontinue paroxetine, buspirone, and any concurrently administered serotonergic agents; initiate supportive and symptomatic treatment⁶¹¹
Cimetidine	Increased plasma paroxetine concentrations¹ ¹⁴⁷ ²⁶²	Adjust paroxetine dosage as needed¹
Clozapine	Possible increases in plasma clozapine concentrations²⁸⁶	Use with caution and monitor closely Adjust dosage as needed²⁸⁶
Digoxin	Digoxin AUC reduced by 15%; limited clinical experience to date¹	Use with caution¹
Fentanyl	Potentially life-threatening serotonin syndrome⁶¹¹	If concomitant use clinically warranted, advise patients of the increased risk for serotonin syndrome, particularly during treatment initiation and dosage increases⁶¹¹ If serotonin syndrome occurs, immediately discontinue paroxetine, fentanyl, and any concurrently administered serotonergic agents; initiate supportive and symptomatic treatment⁶¹¹
5-HT₁ receptor agonists (triptans; e.g., almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan)	Potentially life-threatening serotonin syndrome⁶¹¹	If concomitant use clinically warranted, advise patients of the increased risk for serotonin syndrome, particularly during treatment initiation and dosage increases⁶¹¹ If serotonin syndrome occurs, immediately discontinue paroxetine, the triptan, and any concurrently administered serotonergic agents; initiate supportive and symptomatic treatment⁶¹¹
Linezolid	Potentially life-threatening serotonin syndrome⁴⁰² ⁶¹¹	Do not use concurrently;⁴⁰² consider availability of alternative anti-infectives and weigh benefit of linezolid against risk of serotonin syndrome⁴⁰² ⁶¹¹ If emergency use of linezolid is considered necessary, immediately discontinue paroxetine; monitor closely for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last linezolid dose, whichever comes first⁴⁰² ⁶¹¹ May resume paroxetine 24 hours after last linezolid dose⁴⁰² ⁶¹¹ If nonemergency use of linezolid is planned, withhold paroxetine for at least 2 weeks prior to initiating linezolid⁴⁰² Do not initiate paroxetine in patients receiving linezolid⁴⁰² ⁶¹¹ If urgent treatment of a psychiatric condition is necessary, consider other interventions, including hospitalization; may initiate paroxetine 24 hours after last linezolid dose⁴⁰² ⁶¹¹
Lithium	Potentially life-threatening serotonin syndrome⁶¹¹ Pharmacokinetic interaction unlikely⁶¹¹	If concomitant use clinically warranted, exercise caution and advise patients of the increased risk for serotonin syndrome, particularly during treatment initiation and dosage increases⁶¹¹ If serotonin syndrome occurs, immediately discontinue paroxetine, lithium, and any concurrently administered serotonergic agents; initiate supportive and symptomatic treatment⁶¹¹
MAO inhibitors	Potentially life-threatening serotonin syndrome⁶¹¹	Concomitant use contraindicated⁶¹¹ Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor intended to treat psychiatric disorders and initiation of paroxetine, and vice versa⁶¹¹
Methylene blue	Potentially life-threatening serotonin syndrome⁴⁰⁴ ⁴⁰⁵ ⁶¹¹ Most cases occurred when methylene blue was used as a diagnostic (visualizing) dye^† (1–8 mg/kg IV) during parathyroid surgery; unclear whether there is a risk of serotonin syndrome when methylene blue is administered by other routes or in lower IV doses in patients receiving serotonergic drugs⁴⁰⁴ ⁴⁰⁵ ⁶¹¹	Generally should not use methylene blue in patients receiving paroxetine; ⁴⁰⁴ consider availability of alternative interventions and weigh benefits of IV methylene blue against risk of serotonin syndrome⁴⁰⁴ ⁶¹¹ If emergency use of IV methylene blue is considered necessary, immediately discontinue paroxetine and monitor for symptoms of serotonin syndrome for 2 weeks or until 24 hours after last methylene blue dose, whichever comes first⁴⁰⁴ ⁶¹¹ May resume paroxetine 24 hours after last dose of IV methylene blue⁴⁰⁴ ⁶¹¹ If nonemergency use of methylene blue is planned, withhold paroxetine for at least 2 weeks prior to initiating methylene blue⁴⁰⁴ Do not initiate paroxetine in patients receiving IV methylene blue⁴⁰⁴ ⁶¹¹ If urgent treatment of a psychiatric condition is necessary, consider other interventions, including hospitalization; may initiate paroxetine 24 hours after last IV methylene blue dose⁴⁰⁴ ⁶¹¹
Metoprolol	Severe hypotension possible¹	Use with caution⁵⁰ ²⁶⁴ ²⁷¹
NSAIAs (e.g., aspirin)	Increased risk of bleeding¹ ³²³ ³¹² ³²⁴ ³²⁵	Use caution¹
Perphenazine	Possible inhibition of metabolism by paroxetine¹	Use caution¹
Phenobarbital	Decreased AUC and elimination half-life of paroxetine¹	Adjust dosage as needed¹
Phenytoin	Decreased AUC and elimination half-life of paroxetine and increased plasma phenytoin concentration¹	Adjust dosages as needed¹
Pimozide	Increased AUC and peak plasma concentrations of pimozide¹ ³¹² Possible increased risk of QT-interval prolongation¹ ³¹²	Concomitant use contraindicated¹ ³¹²
Procyclidine	Increased plasma procyclidine concentrations ¹	If anticholinergic effects are seen, decrease procyclidine dosage¹
Propranolol	Paroxetine did not affect plasma propranolol concentrations; effects of propranolol on plasma paroxetine concentrations not evaluated¹
Protein-bound drugs	Potential for displacement of paroxetine or other protein-bound drugs from binding sites¹	Monitor patients for potential adverse effects ¹
Risperidone	Increased plasma risperidone concentrations, decreased plasma 9-hydroxyrisperidone (active metabolite) concentrations, and increased plasma concentrations of active moiety (risperidone plus 9-hydroxyrisperidone)¹ ³²² Generally well tolerated; possible risk of parkinsonian symptoms³²²	Carefully monitor patients; consider monitoring plasma risperidone concentrations³²² Consider lower initial dosage of paroxetine (10–20 mg daily)³²²
St. John's wort (Hypericum perforatum)	Potentially life-threatening serotonin syndrome⁶¹¹	If concomitant use clinically warranted, advise patients of the increased risk for serotonin syndrome, particularly during treatment initiation and dosage increases⁶¹¹ If serotonin syndrome occurs, immediately discontinue paroxetine, St. John's wort, and any concurrently administered serotonergic agents; initiate supportive and symptomatic treatment⁶¹¹
Thioridazine	Potentially serious or fatal reaction (e.g., torsade de pointes)¹	Concomitant use contraindicated¹
Tramadol	Potentially life-threatening serotonin syndrome⁶¹¹	If concomitant use clinically warranted, advise patients of the increased risk for serotonin syndrome, particularly during treatment initiation and dosage increases⁶¹¹ If serotonin syndrome occurs, immediately discontinue paroxetine, tramadol, and any concurrently administered serotonergic agents; initiate supportive and symptomatic treatment⁶¹¹
Tryptophan	Potentially life-threatening serotonin syndrome⁶¹¹	If concomitant use clinically warranted, advise patients of the increased risk for serotonin syndrome, particularly during treatment initiation and dosage increases⁶¹¹ If serotonin syndrome occurs, immediately discontinue paroxetine, tryptophan, and any concurrently administered serotonergic agents; initiate supportive and symptomatic treatment⁶¹¹
Warfarin	Possible increased risk of bleeding¹ ⁶ ¹⁴⁷	Use with caution¹

PARoxetine Pharmacokinetics

Absorption

Bioavailability

Completely absorbed following oral administration.¹

Oral bioavailability in humans not fully elucidated to date.¹

Equally bioavailable from commercially available conventional tablets and suspension.^a

Food

Food does not substantially affect the absorption of paroxetine.¹⁹ ⁹²

Special Populations

In geriatric patients, trough paroxetine concentrations are 70–80% greater than in younger patients.¹

In patients with renal impairment (Cl_cr <30 mL/minute), mean plasma paroxetine concentrations are approximately 4 times greater than those seen in healthy individuals.¹

Hepatic impairment may increase plasma concentrations twofold.¹

Distribution

Extent

Widely distributed in the body, including the CNS and breast milk.¹

Plasma Protein Binding

≥93%¹

Elimination

Metabolism

Extensively metabolized, ¹ ⁹⁴ partially by CYP2D6.¹ Metabolites are essentially inactive.¹ ⁶ ⁸⁴ Inhibits activity of CYP2D6.¹ ⁹¹

Elimination Route

Eliminated principally in urine and feces (probably via bile).¹ ⁹⁴

Half-life

Averages approximately 21–24 hours.¹ ³ ⁴ ⁵ ⁶ ¹⁹ ⁸³ ⁸⁹

Special Populations

In geriatric individuals, elimination half-life may be increased (e.g., to about 36 hours).³ ⁸³

Stability

Storage

Oral

Conventional Tablets

15–30°C.¹

Extended-release Tablets

≤25°C.³⁰⁴

Suspension

≤25°C.¹ ³⁰⁴

Actions

Mechanism of action as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the CNS resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).¹ ⁴ ⁶ ⁸⁴
Has little or no effect on other neurotransmitters¹ ⁴ ⁶ ⁸⁴ or any clinically important anticholinergic, antihistaminic, or adrenergic (α₁, α₂, β) blocking activity at usual therapeutic dosages.¹ ⁴ ⁸⁴ ⁸⁵
Generally less sedating than most older antidepressants.¹ ² ³ ¹⁸ ¹⁹ ²⁴ ⁶² ⁷² ⁷³

Advice to Patients

Importance of providing copy of written patient information (medication guide) each time paroxetine is dispensed.³¹⁴ ³¹⁵ ³²⁰ ⁶¹¹ Importance of advising patients to read the patient information before taking paroxetine and each time the prescription is filled.⁶¹¹
Risk of suicidality; importance of patients, caregivers, and families being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.³¹⁴ ³¹⁵ ³²⁰ ⁶¹¹ (See Worsening of Depression and Suicidality Risk under Cautions.)
Potential risk of serotonin syndrome, particularly with concurrent use of paroxetine and 5-HT₁ receptor agonists (also called triptans), tramadol, tryptophan, other serotonergic agents, or antipsychotic agents.⁶¹¹ Importance of immediately contacting clinician if manifestations of serotonin syndrome develop (e.g., restlessness, hallucinations, delirium, loss of coordination, fast heart beat, increased body temperature, sweating, muscle stiffness, labile BP, diarrhea, coma, nausea, vomiting, confusion).⁶¹¹
Importance of continuing therapy even if improvement is not evident for 4 weeks, unless directed otherwise by clinician.¹ ³
Importance of avoiding some activities (e.g., operating machinery, driving a motor vehicle) until effects on the individual are known.¹ ³
Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, or of use of alcohol-containing beverages or products.¹ ³
Risk of fetal harm.³³⁷ ³³⁸ ³⁴³ ³⁵⁸ ⁶¹¹ Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.⁶¹¹ If a woman becomes pregnant while receiving paroxetine, inform her of the potential hazard to the fetus.³³⁷ ³³⁸ ³⁴³ ³⁵⁸ Unless the potential benefits to the mother justify continuing treatment, consider either discontinuing paroxetine therapy or switching to another antidepressant.³³⁷ ³³⁸ ³⁴³ ³⁵⁸ For women who intend to become pregnant or are in their first trimester of pregnancy, initiate paroxetine only after consideration of other available treatment options.³³⁷ ³³⁸ ³⁴³ ³⁵⁸ (See Pregnancy under Cautions.)
Importance of informing patients of other important precautionary information.¹ ³ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

PARoxetine Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Suspension	10 mg (of paroxetine) per 5 mL	Paxil (with parabens, propylene glycol, saccharin sodium, and sorbitol)	GlaxoSmithKline
	Tablets, extended-release, film-coated	12.5 mg (of paroxetine)	Paxil CR	GlaxoSmithKline
		25 mg (of paroxetine)	Paxil CR	GlaxoSmithKline
		37.5 mg (of paroxetine)	Paxil CR	GlaxoSmithKline
	Tablets, film-coated	10 mg (of paroxetine)*	Paxil (scored)	GlaxoSmithKline
		20 mg (of paroxetine)*	Paxil (scored)	GlaxoSmithKline
		30 mg (of paroxetine)*	Paxil	GlaxoSmithKline
		40 mg (of paroxetine)*	Paxil	GlaxoSmithKline

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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393. Sindrup SH, Bjerre U, Dejgaard A et al. The selective serotonin reuptake inhibitor citalopram relieves the symptoms of diabetic neuropathy. Clin Pharmacol Ther. 1992; 52:547-52. http://www.ncbi.nlm.nih.gov/pubmed/1424428?dopt=AbstractPlus

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404. US Food and Drug Administration. Drug Safety Communication: Serious CNS reactions possible when methylene blue is given to patients taking certain psychiatric medications. 2011 Jul 26. From FDA website. http://www.fda.gov/Drugs/DrugSafety/ucm263190.htm

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a. GlaxoSmithKline. Paxil (paroxetine hydrochloride) tablets and oral suspension prescribing information. 2006 May.

b. Dear healthcare professional letter regarding changes to the Clinical Worsening and Suicide Risk subsection of the Warnings section in the labels for Paxil (paroxetine hydrochloride) and Paxil CR (paroxetine HCl). Philadelphia, PA: GlaxoSmithKline; 2006 May.

c. GlaxoSmithKline. Paxil CR (paroxetine hydrochloride) controlled-release tablets prescribing information. 2006 May.

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Major Depressive Disorder

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Obsessive-Compulsive Disorder

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Social Phobia

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