PARoxetine (Lexi-Drugs)

ALERT: US Boxed Warning
  Suicidality and antidepressant drugs:
Pronunciation

(pa ROKS e teen)

Brand Names: US

Brisdelle; Paxil; Paxil CR; Pexeva

Brand Names: Canada

ACT PARoxetine; AG-Paroxetine; APO-PARoxetine; Auro-PARoxetine; BIO-PARoxetine; DOM-PARoxetine; JAMP-PARoxetine; M-Paroxetine; Mar-PARoxetine; MINT-Paroxetine; MYLAN-PARoxetine [DSC]; NRA-Paroxetine; NU-PARoxetine [DSC]; PARoxetine-10; PARoxetine-20; PARoxetine-30; Paxil; Paxil CR; PMS-PARoxetine; Priva-PARoxetine; Q-PARoxetine [DSC]; RIVA-PARoxetine; SANDOZ PARoxetine; TARO-PARoxetine; TEVA-PARoxetine

Dosing: Adult

Major depressive disorder (MDD): Oral:

Paxil, Pexeva: Initial: 20 mg once daily, preferably in the morning; increase if needed by 10 mg/day increments at intervals of at least 1 week; maximum dose: 50 mg/day

Paxil CR: Initial: 25 mg once daily; increase if needed by 12.5 mg/day increments at intervals of at least 1 week; maximum dose: 62.5 mg/day

Generalized anxiety disorder (GAD) (Paxil, Pexeva): Oral: Initial: 20 mg once daily, preferably in the morning (if dose is increased, adjust in increments of 10 mg/day at 1-week intervals); doses of 20 to 50 mg/day were used in clinical trials, however, no greater benefit was seen with doses >20 mg.

Obsessive-compulsive disorder (OCD) (Paxil, Pexeva): Oral: Initial: 20 mg once daily, preferably in the morning; increase if needed by 10 mg/day increments at intervals of at least 1 week; recommended dose: 40 mg/day; range: 20 to 60 mg/day; maximum dose: 60 mg/day

Panic disorder: Oral:

Paxil, Pexeva: Initial: 10 mg once daily, preferably in the morning; increase if needed by 10 mg/day increments at intervals of at least 1 week; recommended dose: 40 mg/day; range: 10 to 60 mg/day; maximum dose: 60 mg/day

Paxil CR: Initial: 12.5 mg once daily; increase if needed by 12.5 mg/day at intervals of at least 1 week; maximum dose: 75 mg/day

Premenstrual dysphoric disorder (PMDD) (Paxil CR): Oral: Initial: 12.5 mg once daily in the morning; may be increased to 25 mg/day; dosing changes should occur at intervals of at least 1 week. May be given daily throughout the menstrual cycle or limited to the luteal phase.

Post-traumatic stress disorder (PTSD) (Paxil): Oral: Initial: 20 mg once daily, preferably in the morning; increase if needed by 10 mg/day increments at intervals of at least 1 week; range: 20 to 50 mg. Limited data suggest doses of 40 mg/day were not more efficacious than 20 mg/day.

Social anxiety disorder: Oral:

Paxil: Initial: 20 mg once daily, preferably in the morning; recommended dose: 20 mg/day; range: 20 to 60 mg/day; doses >20 mg may not have additional benefit

Paxil CR: Initial: 12.5 mg once daily, preferably in the morning; may be increased by 12.5 mg/day at intervals of at least 1 week; maximum dose: 37.5 mg/day

Vasomotor symptoms of menopause:

Brisdelle: 7.5 mg once daily at bedtime

Paxil: (off-label use): 10 to 20 mg once daily (Stearns 2005)

Paxil CR (off-label use): 12.5 to 25 mg once daily (Stearns 2003)

Discontinuation of therapy:When discontinuing antidepressant treatment that has lasted for >3 weeks, gradually taper the dose (eg, over 2 to 4 weeks) to minimize withdrawal symptoms and detect reemerging symptoms (APA 2010; WFSBP [Bauer 2015]). Reasons for a slower titration (eg, over 4 weeks) include use of a drug with a half-life <24 hours (eg, paroxetine, venlafaxine), prior history of antidepressant withdrawal symptoms, or high doses of antidepressants (APA 2010; Hirsch 2019). If intolerable withdrawal symptoms occur, resume the previously prescribed dose and/or decrease dose at a more gradual rate (Shelton 2001). Select patients (eg, those with a history of discontinuation syndrome) on long-term treatment (>6 months) may benefit from tapering over >3 months (WFSBP [Bauer 2015]). Evidence supporting ideal taper rates is limited (Shelton 2001; WFSBP [Bauer 2015]).

MAO inhibitor recommendations:

Switching to or from an MAO inhibitor intended to treat psychiatric disorders:

Allow 14 days to elapse between discontinuing an MAO inhibitor intended to treat psychiatric disorders and initiation of paroxetine.

Allow 14 days to elapse between discontinuing paroxetine and initiation of an MAO inhibitor intended to treat psychiatric disorders.

Dosing: Geriatric

Major depressive disorder (MDD), obsessive compulsive disorder (OCD), panic attack, social anxiety disorder:

Paxil, Pexeva: Oral: Initial: 10 mg/day; increase if needed by 10 mg/day increments at intervals of at least 1 week; maximum dose: 40 mg/day

Paxil CR: Initial: 12.5 mg/day; increase if needed by 12.5 mg/day increments at intervals of at least 1 week; maximum dose: 50 mg/day

Discontinuation of therapy: Refer to adult dosing.

MAO inhibitor recommendations: Refer to adult dosing.

Dosing: Renal Impairment: Adult

Brisdelle: No dosage adjustment necessary.

Paxil, Paxil CR, Pexeva:

CrCl 30-60 mL/minute: Plasma concentration is 2 times that seen in normal function. There are no dosage adjustments provided in manufacturer’s labeling.

Severe impairment (CrCl <30 mL/minute): Mean plasma concentration is ~4 times that seen in normal function.

Paxil, Pexeva: Initial: 10 mg/day; increase if needed by 10 mg/day increments at intervals of at least 1 week; maximum dose: 40 mg/day

Paxil CR: Initial: 12.5 mg/day; increase if needed by 12.5 mg/day increments at intervals of at least 1 week; maximum dose: 50 mg/day

Dosing: Hepatic Impairment: Adult

In hepatic dysfunction, plasma concentration is 2 times that seen in normal function.

Brisdelle: No dosage adjustment necessary.

Paxil, Paxil CR, Pexeva:

Mild-to-moderate impairment: There are no dosage adjustments provided in manufacturer’s labeling.

Severe impairment:

Paxil, Pexeva: Initial: 10 mg/day; increase if needed by 10 mg/day increments at intervals of at least 1 week; maximum dose: 40 mg/day

Paxil CR: Initial: 12.5 mg/day; increase if needed by 12.5 mg/day increments at intervals of at least 1 week; maximum dose: 50 mg/day

Dosing: Pediatric

Obsessive-compulsive disorder (OCD): Limited data available: Children and Adolescents 7 to 17 years: Oral: Initial: 10 mg once daily; titrate every 7 to 14 days in 10 mg/day increments; maximum daily dose: 60 mg/day. Dosing based on two trials. The first was a 12-week open-label trial of paroxetine in 20 outpatients 8 to 17 years of age that demonstrated the potential clinical usefulness in pediatric OCD (Rosenberg 1999). The second trial demonstrated efficacy of paroxetine in a 10-week, randomized, double-blind, placebo-controlled trial conducted in 207 pediatric patients (aged 7 to 17 years) with OCD; the overall mean dose was 20.3 mg/day for children and 26.8 mg/day for adolescents (Geller 2004).

Social anxiety disorder: Limited data available: Children and Adolescents 8 to 17 years: Oral: Initial: 10 mg once daily; titrate at intervals of at least 7 days in 10 mg/day increments; maximum daily dose: 50 mg/day. Dosing based on a 16-week multicenter, randomized, double-blind, placebo-controlled trial that reported the efficacy of paroxetine in pediatric patients (aged 8 to 17 years) with social anxiety disorder; 163 patients were randomized to receive paroxetine; the overall mean dose was 21.7 mg/day for children and 26.1 mg/day for adolescents (Wagner 2004).

Discontinuation of therapy: Upon discontinuation of antidepressant therapy, gradually taper the dose to minimize the incidence of withdrawal symptoms and allow for the detection of reemerging symptoms. Evidence supporting ideal taper rates is limited. APA and NICE guidelines suggest tapering therapy over at least several weeks with consideration to the half-life of the antidepressant; antidepressants with a shorter half-life may need to be tapered more conservatively. In addition for long-term treated patients, WFSBP guidelines recommend tapering over 4 to 6 months. If intolerable withdrawal symptoms occur following a dose reduction, consider resuming the previously prescribed dose and/or decrease dose at a more gradual rate (APA 2010; Bauer 2002; Haddad 2001; NCCMH 2010; Schatzberg 2006; Shelton 2001; Warner 2006).

MAO inhibitor recommendations:

Switching to or from an MAO inhibitor intended to treat psychiatric disorders:

Allow 14 days to elapse between discontinuing an MAO inhibitor intended to treat psychiatric disorders and initiation of paroxetine.

Allow 14 days to elapse between discontinuing paroxetine and initiation of an MAO inhibitor intended to treat psychiatric disorders.

Use with other MAO inhibitors (linezolid or IV methylene blue):

Do not initiate paroxetine in patients receiving linezolid or IV methylene blue; consider other interventions for psychiatric condition.

If urgent treatment with linezolid or IV methylene blue is required in a patient already receiving paroxetine and potential benefits outweigh potential risks, discontinue paroxetine promptly and administer linezolid or IV methylene blue. Monitor for serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or IV methylene blue, whichever comes first. May resume paroxetine 24 hours after the last dose of linezolid or IV methylene blue

Dosing: Renal Impairment: Pediatric

There are no pediatric specific recommendations; based on pharmacokinetics in adult patients, plasma concentration is 2 times that seen in normal function in mild to moderate renal impairment (CrCl 30 to 60 mL/minute), and in severe impairment (CrCl <30 mL/minute) mean plasma concentration is ~4 times that seen in normal function; dosing adjustment suggested.

Dosing: Hepatic Impairment: Pediatric

There are no pediatric specific recommendations; based on pharmacokinetics in adult patients with hepatic dysfunction, plasma concentration is 2 times that seen in normal function; dosing adjustment suggested.

Use: Labeled Indications

Generalized anxiety disorder (immediate release): For the treatment of generalized anxiety disorder (GAD)

Major depressive disorder (immediate and controlled release): For the treatment of major depressive disorder (MDD)

Obsessive-compulsive disorder (immediate release): For the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD)

Panic disorder (immediate and controlled release): For the treatment of panic disorder, with or without agoraphobia

Post-traumatic stress disorder (immediate release): For the treatment of post-traumatic stress disorder (PTSD)

Premenstrual dysphoric disorder (controlled release): For the treatment of premenstrual dysphoric disorder (PMDD)

Social anxiety disorder (immediate and controlled release): For the treatment of social anxiety disorder, also known as social phobia

Vasomotor symptoms of menopause (Brisdelle only): For the treatment of moderate to severe vasomotor symptoms associated with menopause

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Anxiety Disorders:

American Academy of Child and Adolescent Psychiatry, “Practice parameter for the assessment and treatment of children and adolescents with obsessive-compulsive disorder,” 2012

American Psychiatric Association, “Practice Guideline for the Treatment of Patients with Panic Disorder,” 2009

Anxiety Disorders Association of Canada, “Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders,” 2014

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and posttraumatic stress disorders, First Revision,” 2008

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and posttraumatic stress disorder in primary care,” 2012

Bipolar Disorder:

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD), “Collaborative Update of CANMAT Guidelines for the Management of Patients with Bipolar Disorder – Update 2013,” February 2013

Depression:

American Psychiatric Association, Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition, May 2010

Canadian Network for Mood and Anxiety Treatments (CANMAT), “Clinical Guidelines for the Management of Major Depressive Disorder In Adults,” October 2009

National Collaborating Centre for Mental Health (NCCMH), “Depression: The NICE Guideline on the Treatment and Management of Depression in Adults (Updated Edition).” 2010.

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for Biological Treatment of Unipolar Depressive Disorders, Part 1: Update 2013 on the Acute and Continuation Treatment of Unipolar Depressive Disorders,” 2013.

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for Biological Treatment of Unipolar Depressive Disorders, Part 2: Maintenance Treatment of Major Depressive Disorder and Treatment of Chronic Depressive Disorders and Subthreshold Depressions,” 2002.

Obsessive-Compulsive Disorder (OCD):

American Psychiatric Association, “Practice Guideline for the Treatment of Patients with Obsessive-Compulsive Disorder,” 2007

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and posttraumatic stress disorders, First Revision,” 2008

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and posttraumatic stress disorder in primary care,” 2012

Post Traumatic Stress Disorder (PTSD):

American Psychiatric Association, “Practice Guideline for the Treatment of Patients with Acute Stress Disorder and Posttraumatic Stress Disorder,” 2004

American Psychiatric Association, “Practice Guideline for the Treatment of Patients with Acute Stress Disorder and Posttraumatic Stress Disorder,” Guideline Watch (March 2009)

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and posttraumatic stress disorder in primary cares, First Revision,” 2008

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and posttraumatic stress disorder in primary care,” 2012

Vasomotor Symptoms of Menopause:

Endocrine Society (ES), Treatment of Symptoms of the Menopause, 2015

North American Menopause Society (NAMS), Nonhormonal management of menopause-associated vasomotor symptoms, 2015

Administration: Oral

May be administered without regard to meals. Paxil, Paxil CR, and Pexeva should preferentially be administered in the morning; whereas Brisdelle is recommended to be administered at bedtime. Do not crush, break, or chew controlled-release tablets or Pexeva tablets (film-coated).

Administration: Pediatric

Oral: May be administered without regard to meals; administration with food may decrease GI side effects; shake suspension well before use. Paxil, Paxil CR, and Pexeva should preferentially be administered in the morning. Do not chew or crush immediate or controlled release tablet, swallow whole

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 3]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends single gloving for administration of intact tablets or capsules (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).

Storage/Stability

Capsules: Store between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from light and humidity.

Tablets: Store immediate-release tablets between 15°C and 30°C (59°F and 86°F) and controlled-release tablets at or below 25°C (77°F).

Suspension: Store at or below 25°C (77°F).

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, headache, nausea, vomiting, constipation, diarrhea, dry mouth, insomnia, loss of strength and energy, tremors, lack of appetite, or yawning. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, confusion), panic attacks, mood changes, irritability, signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, severe diarrhea), signs of low sodium (headache, difficulty focusing, memory impairment, confusion, weakness, seizures, or change in balance), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), seizures, vision changes, eye pain, severe eye irritation, confusion, change in balance, agitation, twitching, sweating, muscle rigidity, severe anxiety, abnormal heartbeat, hallucinations, severe dizziness, passing out, bone pain, excessive weight loss, burning or numbness feeling, sexual dysfunction, or priapism (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Geriatric Patients: High-Risk Medication:
Medication Guide and/or Vaccine Information Statement (VIS)
Contraindications

Concurrent use with or within 14 days of MAOIs intended to treat psychiatric disorders; initiation in patients being treated with linezolid or methylene blue IV; concomitant use with pimozide or thioridazine; hypersensitivity to paroxetine or any of its inactive ingredients; pregnancy (Brisdelle only).

Warnings/Precautions

Major psychiatric warnings:

• Suicidal thinking/behavior: [US Boxed Warning]: Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (18 to 24 years of age) with major depressive disorder (MDD) and other psychiatric disorders; consider risk prior to prescribing. Short-term studies did not show an increased risk in patients >24 years of age and showed a decreased risk in patients ≥65 years. Closely monitor patients for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial 1 to 2 months of therapy or during periods of dosage adjustments (increases or decreases); the patient’s family or caregiver should be instructed to closely observe the patient and communicate condition with healthcare provider. A medication guide concerning the use of antidepressants should be dispensed with each prescription. Paroxetine is not FDA approved for use in children.

• The possibility of a suicide attempt is inherent in major depression and may persist until remission occurs. Worsening depression and severe abrupt suicidality that are not part of the presenting symptoms may require discontinuation or modification of drug therapy. Use caution in high-risk patients during initiation of therapy.

• Prescriptions should be written for the smallest quantity consistent with good patient care. The patient’s family or caregiver should be alerted to monitor patients for the emergence of suicidality and associated behaviors such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania; patients should be instructed to notify their healthcare provider if any of these symptoms or worsening depression or psychosis occur.

Concerns related to adverse effects:

• Akathisia: Inability to remain still due to feelings of agitation or restlessness has been observed with paroxetine and other SSRIs. Usually occurs within the first few weeks of therapy.

• Anticholinergic effects: Has low potential for sedation and anticholinergic effects relative to cyclic antidepressants; however among the SSRI class these effects are relatively higher.

• Bleeding risk: May impair platelet aggregation resulting in increased risk of bleeding events, particularly if used concomitantly with aspirin, NSAIDs, warfarin or other anticoagulants. Bleeding related to SSRI use has been reported to range from relatively minor bruising and epistaxis to life-threatening hemorrhage.

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

• Fractures: Bone fractures have been associated with antidepressant treatment. Consider the possibility of a fragility fracture if an antidepressant-treated patient presents with unexplained bone pain, point tenderness, swelling, or bruising (Rabenda 2013; Rizzoli, 2012).

• Ocular effects: May cause mild pupillary dilation, which can lead to an episode of narrow-angle glaucoma in susceptible individuals. Consider evaluating patients who have not had an iridectomy for narrow-angle glaucoma risk factors.

• Serotonin syndrome: Potentially life-threatening serotonin syndrome (SS) has occurred with serotonergic agents (eg, SSRIs, SNRIs), particularly when used in combination with other serotonergic agents (eg, triptans, TCAs, fentanyl, lithium, tramadol, buspirone, St John’s wort, tryptophan) or agents that impair metabolism of serotonin (eg, MAO inhibitors intended to treat psychiatric disorders, other MAO inhibitors [ie, linezolid and intravenous methylene blue]). Monitor patients closely for signs of SS such as mental status changes (eg, agitation, hallucinations, delirium, coma); autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis); neuromuscular changes (eg, tremor, rigidity, myoclonus); GI symptoms (eg, nausea, vomiting, diarrhea); and/or seizures. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

• Sexual dysfunction: May cause or exacerbate sexual dysfunction.

• SIADH and hyponatremia: SSRIs and SNRIs have been associated with the development of SIADH; hyponatremia has been reported rarely (including severe cases with serum sodium <110 mmol/L), predominately in the elderly. Volume depletion and/or concurrent use of diuretics likely increases risk.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease; paroxetine has not been systemically evaluated in patients with a recent history of MI or unstable heart disease.

• Hepatic impairment: Use with caution in patients with hepatic impairment; clearance is decreased and plasma concentrations are increased; a lower dosage may be needed.

• Mania/hypomania: May worsen psychosis in some patients or precipitate a shift to mania or hypomania in patients with bipolar disorder. Monotherapy in patients with bipolar disorder should be avoided. Patients presenting with depressive symptoms should be screened for bipolar disorder. Paroxetine is not FDA approved for the treatment of bipolar depression.

• Renal impairment: Use with caution in patients with renal impairment; clearance is decreased and plasma concentrations are increased; a lower dosage may be needed.

• Seizure disorder: Use with caution in patients with a previous seizure disorder or condition predisposing to seizures such as brain damage or alcoholism.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Brisdelle: Brisdelle contains a lower dose than what is required for the treatment of psychiatric conditions. Patients who require paroxetine for the treatment of psychiatric conditions should discontinue Brisdelle and begin treatment with a paroxetine-containing medication which provides an adequate dosage.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Discontinuation syndrome: Abrupt discontinuation or interruption of antidepressant therapy has been associated with a discontinuation syndrome. Symptoms arising may vary with antidepressant however commonly include nausea, vomiting, diarrhea, headaches, lightheadedness, dizziness, diminished appetite, sweating, chills, tremors, paresthesias, fatigue, somnolence, and sleep disturbances (eg, vivid dreams, insomnia). Less common symptoms include electric shock-like sensations, cardiac arrhythmias (more common with tricyclic antidepressants), myalgias, parkinsonism, arthralgias, and balance difficulties. Psychological symptoms may also emerge such as agitation, anxiety, akathisia, panic attacks, irritability, aggressiveness, worsening of mood, dysphoria, mood lability, hyperactivity, mania/hypomania, depersonalization, decreased concentration, slowed thinking, confusion, and memory or concentration difficulties. Greater risks for developing a discontinuation syndrome have been associated with antidepressants with shorter half-lives, longer durations of treatment, and abrupt discontinuation. For antidepressants of short or intermediate half-lives, symptoms may emerge within 2 to 5 days after treatment discontinuation and last 7 to 14 days (APA 2010; Fava 2006; Haddod 2001; Shelton 2001; Warner 2006).

• Electroconvulsive therapy: May increase the risks associated with electroconvulsive therapy; consider discontinuing, when possible, prior to ECT treatment.

Geriatric Considerations

Paroxetine is the most sedating and anticholinergic of the selective serotonin reuptake inhibitors.

A systematic review and meta-analysis of antidepressant placebo-controlled trials in persons with depression and dementia found evidence “suggestive” of efficacy but not of sufficient strength to “confirm” efficacy (Nelson 2011). Older patients with depression being treated with an antidepressant should be closely monitored for response and adverse effects.

Warnings: Additional Pediatric Considerations

The FDA recommends that paroxetine not be used in pediatric patients for the treatment of depression. Three well-controlled trials in pediatric patients with depression have failed to show therapeutic superiority over placebo; in addition, an increased risk for suicidal behavior was observed in patients receiving paroxetine when compared to other SSRIs (Dopheide, 2006). SSRI-associated behavioral activation (ie, restlessness, hyperkinesis, hyperactivity, agitation) is two- to threefold more prevalent in children compared to adolescents; it is more prevalent in adolescents compared to adults. Somnolence (including sedation and drowsiness) is more common in adults compared to children and adolescents (Safer, 2006).

An SSRI discontinuation syndrome similar to that described in adults has been reported in six children (Diler, 2002). May cause abnormal bleeding (eg, ecchymosis, purpura, upper GI bleeding); use with caution in patients with impaired platelet aggregation and with concurrent use of aspirin, NSAIDs, or other drugs that affect coagulation. A recent report describes five children (age: 8 to 15 years) who developed epistaxis (n=4) or bruising (n=1) while receiving SSRI therapy (sertraline) (Lake, 2000). SSRI-associated vomiting is two- to threefold more prevalent in children compared to adolescents and is more prevalent in adolescents compared to adults (Safer, 2006).

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP, 1997; Shehab, 2009).

Pregnancy Risk Factor

D/X (product specific)

Pregnancy Considerations

Paroxetine crosses the placenta (Hendrick Stowe 2003). An increased risk of teratogenic effects, including cardiovascular defects, may be associated with maternal use of paroxetine or other SSRIs; however, available information is conflicting. Nonteratogenic effects in the newborn following SSRI/SNRI exposure late in the third trimester include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo- or hypertonia, hyper-reflexia, jitteriness, irritability, constant crying, and tremor. Symptoms may be due to the toxicity of the SSRIs/SNRIs or a discontinuation syndrome and may be consistent with serotonin syndrome associated with SSRI treatment. Persistent pulmonary hypertension of the newborn (PPHN) has also been reported with SSRI exposure. The long-term effects of in utero SSRI exposure on infant development and behavior are not known.

Due to pregnancy-induced physiologic changes, some pharmacokinetic parameters of paroxetine may be altered. The maternal CYP2D6 genotype also influences paroxetine plasma concentrations during pregnancy (Hostetter 2000; Ververs 2009).

The manufacturer suggests discontinuing paroxetine or switching to another antidepressant unless the benefits of therapy justify continuing treatment during pregnancy; consider other treatment options for women who are planning to become pregnant. The ACOG recommends that therapy with SSRIs or SNRIs during pregnancy be individualized; treatment of depression during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary health care provider, and pediatrician. The ACOG also recommends that therapy with paroxetine be avoided during pregnancy if possible and that fetuses exposed in early pregnancy be assessed with a fetal echocardiography (ACOG 2008). Other guidelines note that treatment with paroxetine should not be initiated in pregnant women (Bauer 2013). According to the American Psychiatric Association (APA), the risks of medication treatment should be weighed against other treatment options and untreated depression. The use of paroxetine is not recommended as first line therapy during pregnancy. For women who discontinue antidepressant medications during pregnancy and who may be at high risk for postpartum depression, the medications can be restarted following delivery (APA 2010). Treatment algorithms have been developed by the ACOG and the APA for the management of depression in women prior to conception and during pregnancy (Yonkers 2009).

Menopausal vasomotor symptoms do not occur during pregnancy; therefore, the use of paroxetine for the treatment of menopausal vasomotor symptoms is contraindicated in pregnant women.

Pregnant women exposed to antidepressants during pregnancy are encouraged to enroll in the National Pregnancy Registry for Antidepressants (NPRAD). Women 18 to 45 years of age or their health care providers may contact the registry by calling 844-405-6185. Enrollment should be done as early in pregnancy as possible.

Breast-Feeding Considerations

Paroxetine is present in breast milk.

The relative infant dose (RID) of paroxetine is 5.6% when calculated using the highest breast milk concentration located and compared to a weight-adjusted maternal dose of 50 mg/day.

In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000). However some sources note breastfeeding should only be considered if the RID is <5% for psychotropic agents (Larsen 2015).

The RID of paroxetine was calculated using a milk concentration of 255.3 ng/mL, providing an estimated daily infant dose via breast milk of 0.04 mg/kg/day. This milk concentration was obtained following maternal administration of paroxetine 50 mg/day (Misri 2006). Milk and maternal plasma concentrations are linearly correlated (Misri 2000; Weissman 2004). Paroxetine was measurable in the serum of some breastfed infants (Weissman 2004).

Constant crying, insomnia, lethargy, poor weight gain, and restlessness have been observed in breastfed infants exposed to some SSRIs including paroxetine (Merlob 2004; Nordeng 2001; Uguz 2016; Weissman 2004). Infants of mothers using psychotropic medications should be monitored daily for changes in sleep, feeding patterns, and behavior (Bauer 2013) as well as infant growth and neurodevelopment (Sachs 2013; Sriraman 2015). Maternal use of an SSRI during pregnancy may cause delayed lactogenesis (Marshall 2010).

The manufacturer recommends that caution be used if administered to a breastfeeding woman. When first initiating an antidepressant in a breastfeeding woman, paroxetine may be used; however, other agents may be considered if the women requires long-term therapy and wishes to have another pregnancy. Women successfully treated with paroxetine during pregnancy may continue use while breastfeeding if there are no other contraindications (Berle 2011; Sriraman 2015).

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency varies by dose and indication. Adverse reactions reported as a composite of all indications.

>10%:

Central nervous system: Drowsiness (15% to 24%), insomnia (11% to 24%), headache (6% to 18%), dizziness (6% to 14%)

Dermatologic: Diaphoresis (5% to 14%)

Endocrine & metabolic: Decreased libido (3% to 15%)

Gastrointestinal: Nausea (19% to 26%), xerostomia (9% to 18%), constipation (5% to 16%), diarrhea (9% to 12%)

Genitourinary: Ejaculatory disorder (13% to 28%)

Neuromuscular & skeletal: Weakness (12% to 22%), tremor (4% to 11%)

1% to 10%:

Cardiovascular: Vasodilatation (2% to 4%), chest pain (3%), palpitations (2% to 3%), hypertension (≥1%), tachycardia (≥1%)

Central nervous system: Nervousness (4% to 9%), anxiety (5%), fatigue (5%), agitation (3% to 5%), paresthesia (4%), abnormal dreams (3% to 4%), lack of concentration (3% to 4%), yawning (2% to 4%), depersonalization (≤3%), myoclonus (2% to 3%), amnesia (2%), chills (2%), emotional lability (≥1%), vertigo (≥1%), confusion (1%), myasthenia (1%)

Dermatologic: Skin rash (2% to 3%), pruritus (≥1%)

Endocrine & metabolic: Weight gain (≥1%)

Gastrointestinal: Decreased appetite (5% to 9%), dyspepsia (2% to 5%), flatulence (4%), abdominal pain (4%), nausea and vomiting (4%), increased appetite (2% to 4%), vomiting (2% to 3%), dysgeusia (2%)

Genitourinary: Male genital disease (10%), female genital tract disease (2% to 9%), impotence (2% to 9%), orgasm disturbance (2% to 9%), dysmenorrhea (5%), urinary frequency (2% to 3%), urinary tract infection (2%)

Infection: Infection (5% to 6%)

Neuromuscular & skeletal: Myalgia (2% to 4%), back pain (3%), myopathy (2%), arthralgia (≥1%)

Ophthalmic: Blurred vision (4%), visual disturbance (2% to 4%)

Otic: Tinnitus (≥1%)

Respiratory: Dyspnea (≤7%), pharyngitis (4%), sinusitis (≤4%), rhinitis (3%)

<1%, postmarketing, and/or case reports: Abnormal erythrocytes, abnormal hepatic function tests, acute renal failure, adrenergic syndrome, aggressive behavior, agranulocytosis, akathisia, akinesia, anaphylactoid reaction, anaphylaxis, anemia (various), angina pectoris, angioedema, angle-closure glaucoma, aphasia, aphthous stomatitis, aplastic anemia, asthma, atrial fibrillation, behavioral problems (various), bloody diarrhea, bone marrow aplasia, bradycardia, bronchitis, bulimia nervosa, bundle branch block, cardiac failure, cataract, cellulitis, cerebral ischemia, cerebrovascular accident, change in platelet count, cholelithiasis, colitis, deafness, dehydration, delirium, depression, diabetes mellitus, disorientation, drug dependence, dyskinesia, dysphagia, dyspnea, dystonia, ecchymoses, eclampsia, emphysema, erythema, esophageal achalasia, exfoliative dermatitis, extrapyramidal reaction, fecal impaction, fungal dermatitis, gastroenteritis, goiter, Guillain-Barre syndrome, hallucination, hematemesis, hematologic disease, hematoma, hemoptysis, hemorrhage (eye, gingival, rectal, retinal, vaginal), hemorrhagic pancreatitis, hepatic failure, hepatic necrosis, hepatitis, hepatotoxicity, homicidal ideation, hyperbilirubinemia, hypercholesteremia, hypergammaglobulinemia, hyperglycemia, hyperhidrosis, hypersensitivity reaction, hyperthyroidism, hypoglycemia, hyponatremia, hypotension, hypothyroidism, immune thrombocytopenia, increased blood urea nitrogen, increased creatine phosphokinase, increased lactate dehydrogenase, increased serum alkaline phosphatase, intestinal obstruction, ischemic heart disease, jaundice, ketosis, low cardiac output, lymphadenopathy, malaise, meningitis, migraine, mydriasis, myelitis, myocardial infarction, neuroleptic malignant syndrome (Stevens, 2008), neuropathy, nodal arrhythmia, osteoarthritis, osteoporosis, pancreatitis, pancytopenia, peptic ulcer, peritonitis, phlebitis, pneumonia, prolonged bleeding time, pulmonary edema, pulmonary embolism, pulmonary fibrosis, pulmonary hypertension, restlessness, seizure, sepsis, serotonin syndrome, status epilepticus, Stevens-Johnson syndrome, suicidal ideation, suicidal tendencies, syncope, tetany, thrombophlebitis, thrombosis, tongue edema, torsades de pointes, toxic epidermal necrolysis, uncontrolled diabetes mellitus, vasculitis, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, withdrawal syndrome (including increased dreaming/nightmares, muscle cramps/spasms/twitching, headache, nervousness/anxiety, fatigue/tiredness, restless feeling in legs, and trouble sleeping/insomnia)

Metabolism/Transport Effects

Substrate of CYP2D6 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;Inhibits CYP2D6 (strong)

Drug Interactions 

Abiraterone Acetate: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Management: Avoid concurrent use of abiraterone with CYP2D6 substrates that have a narrow therapeutic index whenever possible. When concurrent use is not avoidable, monitor patients closely for signs/symptoms of toxicity. Risk D: Consider therapy modification

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Risk C: Monitor therapy

Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Ajmaline: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Ajmaline. Risk C: Monitor therapy

Alcohol (Ethyl): May enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Management: Patients receiving selective serotonin reuptake inhibitors should be advised to avoid alcohol. Monitor for increased psychomotor impairment in patients who consume alcohol during treatment with selective serotonin reuptake inhibitors. Risk D: Consider therapy modification

Amphetamines: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Amphetamines. Risk C: Monitor therapy

Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Antiemetics (5HT3 Antagonists): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Antipsychotic Agents: Serotonin Modulators may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Apixaban: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Apixaban. Specifically, the risk for bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely. Risk C: Monitor therapy

Aprepitant: PARoxetine may decrease the serum concentration of Aprepitant. Aprepitant may decrease the serum concentration of PARoxetine. Risk C: Monitor therapy

ARIPiprazole: PARoxetine may enhance the adverse/toxic effect of ARIPiprazole. Specifically, the risk of neuroleptic malignant syndrome may be increased. ARIPiprazole may enhance the serotonergic effect of PARoxetine. This could result in serotonin syndrome. PARoxetine may increase the serum concentration of ARIPiprazole. Management: Aripiprazole dose adjustment is recommended, except when used adjunctively for depression. Consult full interaction monograph or aripiprazole prescribing information for complete details. Risk D: Consider therapy modification

ARIPiprazole Lauroxil: CYP2D6 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of ARIPiprazole Lauroxil. Management: Please refer to the full interaction monograph for details concerning the recommended dose adjustments. Risk D: Consider therapy modification

Asenapine: PARoxetine may enhance the QTc-prolonging effect of Asenapine. Asenapine may increase the serum concentration of PARoxetine. Risk D: Consider therapy modification

Aspirin: Selective Serotonin Reuptake Inhibitors may enhance the antiplatelet effect of Aspirin. Risk C: Monitor therapy

Asunaprevir: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk D: Consider therapy modification

AtoMOXetine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of AtoMOXetine. Management: Initiate atomoxetine at a reduced dose (adult doses — patients up to 70kg: 0.5mg/kg/day; patients 70kg or more: 40mg/day) in patients receiving a strong CYP2D6 inhibitor. Risk D: Consider therapy modification

Benzhydrocodone: CYP2D6 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of Benzhydrocodone. Risk C: Monitor therapy

Beta-Blockers: Selective Serotonin Reuptake Inhibitors may increase the serum concentration of Beta-Blockers. Exceptions: Acebutolol; Atenolol; Betaxolol (Ophthalmic); Betaxolol (Systemic); Bisoprolol; Carteolol (Ophthalmic); Esmolol; Labetalol; Levobunolol; Metipranolol; Nadolol; Penbutolol; Sotalol. Risk C: Monitor therapy

Blood Glucose Lowering Agents: Selective Serotonin Reuptake Inhibitors may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Brexpiprazole: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Brexpiprazole. Management: Reduce brexpiprazole dose to 50% of usual with a strong CYP2D6 inhibitor; this recommendation does not apply if treating major depressive disorder. Reduce to 25% of usual if used with both a strong CYP2D6 inhibitor and a CYP3A4 inhibitor.Risk D: Consider therapy modification

Bromopride: May enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Risk X: Avoid combination

BuPROPion: May enhance the adverse/toxic effect of PARoxetine. Specifically, the risk for seizures and serotonin syndrome may be increased. Risk C: Monitor therapy

BusPIRone: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Selective Serotonin Reuptake Inhibitors may decrease the metabolism of BusPIRone. Management: The combination of a selective serotonin reuptake inhibitor and buspirone should be undertaken with great caution. When combined treatment is clinically indicated, monitor closely for signs of serotonin toxicity/serotonin syndrome. Risk D: Consider therapy modification

Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Risk C: Monitor therapy

Cimetidine: May increase the serum concentration of PARoxetine. Risk C: Monitor therapy

Clarithromycin: May enhance the adverse/toxic effect of PARoxetine. Clarithromycin may enhance the QTc-prolonging effect of PARoxetine. Risk C: Monitor therapy

CloBAZam: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CloZAPine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of CloZAPine. Risk C: Monitor therapy

CNS Depressants: May enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy

Cobicistat: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Codeine: CYP2D6 Inhibitors (Strong) may diminish the therapeutic effect of Codeine. These CYP2D6 inhibitors may prevent the metabolic conversion of codeine to its active metabolite morphine. Risk D: Consider therapy modification

Collagenase (Systemic): Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Risk C: Monitor therapy

CYP2D6 Inhibitors (Moderate): May decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors). Risk D: Consider therapy modification

CYP2D6 Substrates (High risk with Inhibitors): CYP2D6 Inhibitors (Strong) may decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors). Exceptions: Ajmaline; Dapoxetine; Indoramin; Tamoxifen; Timolol (Ophthalmic); Tropisetron. Risk D: Consider therapy modification

Cyproheptadine: May diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Risk C: Monitor therapy

Dabigatran Etexilate: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Dabigatran Etexilate. Agents with Antiplatelet Properties may increase the serum concentration of Dabigatran Etexilate. This mechanism applies specifically to clopidogrel. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Risk C: Monitor therapy

Dacomitinib: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Management: Avoid concurrent use of dacomitinib with CYP2D6 subtrates that have a narrow therapeutic index. Risk D: Consider therapy modification

Dapoxetine: May enhance the adverse/toxic effect of Serotonin Modulators. Risk X: Avoid combination

Darunavir: May decrease the serum concentration of PARoxetine. Risk C: Monitor therapy

Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

Deoxycholic Acid: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Risk C: Monitor therapy

Desmopressin: Selective Serotonin Reuptake Inhibitors may enhance the adverse/toxic effect of Desmopressin. Risk C: Monitor therapy

Deutetrabenazine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Deutetrabenazine. Management: The total daily dose of deutetrabenazine should not exceed 36 mg, and the maximum single dose of deutetrabenazine should not exceed 18 mg with concurrent use of a strong CYP2D6 inhibitor. Risk D: Consider therapy modification

Dextromethorphan: Selective Serotonin Reuptake Inhibitors may enhance the serotonergic effect of Dextromethorphan. Selective Serotonin Reuptake Inhibitors may increase the serum concentration of Dextromethorphan. Management: Avoid the concurrent use of dextromethorphan and SSRIs, particularly fluoxetine and paroxetine, when possible. The risk for this interaction may persist for several weeks following discontinuation of fluoxetine or paroxetine. Risk D: Consider therapy modification

Dosulepin: Selective Serotonin Reuptake Inhibitors may increase the serum concentration of Dosulepin. Risk X: Avoid combination

DOXOrubicin (Conventional): CYP2D6 Inhibitors (Strong) may increase the serum concentration of DOXOrubicin (Conventional). Management: Seek alternatives to strong CYP2D6 inhibitors in patients treated with doxorubicin whenever possible. One U.S. manufacturer (Pfizer Inc.) recommends that these combinations be avoided. Risk D: Consider therapy modification

DULoxetine: May enhance the serotonergic effect of PARoxetine. This could result in serotonin syndrome. PARoxetine may increase the serum concentration of DULoxetine. Management: Coadminister with caution. If duloxetine and paroxetine are used in combination, monitor for signs and symptoms of serotonin toxicity/serotonin syndrome, as well as other toxic effects of duloxetine. Risk D: Consider therapy modification

Edoxaban: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Risk C: Monitor therapy

Eliglustat: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Eliglustat. Management: Reduce the eliglustat dose to 84 mg daily. Avoid use of eliglustat in combination with a strong CYP2D6 inhibitor and a strong or moderate CYP3A4 inhibitor. Risk D: Consider therapy modification

Fat Emulsion (Fish Oil Based): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Fesoterodine: CYP2D6 Inhibitors may increase serum concentrations of the active metabolite(s) of Fesoterodine. Risk C: Monitor therapy

Fosamprenavir: May decrease the serum concentration of PARoxetine. The active metabolite amprenavir is likely responsible for this effect. Risk C: Monitor therapy

Fosaprepitant: PARoxetine may decrease serum concentrations of the active metabolite(s) of Fosaprepitant. Fosaprepitant may decrease the serum concentration of PARoxetine. Risk C: Monitor therapy

Galantamine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Galantamine. Risk C: Monitor therapy

Gilteritinib: May diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Management: Avoid use of this combination if possible. If the combination cannot be avoided, monitor closely for evidence of reduced response to the selective serotonin reuptake inhibitor. Risk D: Consider therapy modification

Glucosamine: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Risk D: Consider therapy modification

HYDROcodone: CYP2D6 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of HYDROcodone. Specifically, concentrations of hydromorphone may be decreased. Risk C: Monitor therapy

Ibritumomab Tiuxetan: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Risk C: Monitor therapy

Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Iloperidone: CYP2D6 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of Iloperidone. Specifically, concentrations of the metabolite P88 may be increased. CYP2D6 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of Iloperidone. Specifically, concentrations of the metabolite P95 may be decreased. CYP2D6 Inhibitors (Strong) may increase the serum concentration of Iloperidone. Management: Reduce iloperidone dose by half when administered with a strong CYP2D6 inhibitor. Risk D: Consider therapy modification

Imatinib: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Indoramin: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Indoramin. Risk C: Monitor therapy

Inotersen: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Ioflupane I 123: Selective Serotonin Reuptake Inhibitors may diminish the diagnostic effect of Ioflupane I 123. Risk C: Monitor therapy

Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Linezolid: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This could result in serotonin syndrome. Management: Consider alternatives to this combination whenever possible. If clinically acceptable, wait at least 2 weeks (5 weeks for fluoxetine) after SSRI discontinuation to initiate linezolid. Risk D: Consider therapy modification

Linezolid: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Management: Due to a risk of serotonin syndrome/serotonin toxicity, discontinue serotonin modulators 2 weeks prior to the administration of linezolid. If urgent initiation of linezolid is needed, discontinue serotonin modulators immediately and monitor closely. Risk D: Consider therapy modification

Lithium: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This could increase the risk of serotonin toxicity/serotonin syndrome. Management: This combination should be undertaken with great caution. When combined treatment is clinically indicated, monitor closely for signs of serotonin toxicity/serotonin syndrome. Risk D: Consider therapy modification

Lofexidine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Lofexidine. Risk C: Monitor therapy

Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Mequitazine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Mequitazine. Risk X: Avoid combination

Metaxalone: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Methylene Blue: Selective Serotonin Reuptake Inhibitors may enhance the serotonergic effect of Methylene Blue. This could result in serotonin syndrome. Risk X: Avoid combination

Methylene Blue: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk X: Avoid combination

Methylphenidate: May enhance the adverse/toxic effect of Serotonin Modulators. Specifically, the risk of serotonin syndrome or serotonin toxicity may be increased. Risk C: Monitor therapy

Metoclopramide: May enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving metoclopramide with selective serotonin reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Risk D: Consider therapy modification

Metoclopramide: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Metoclopramide. Management: Reduce metoclopramide dose to 5 mg 4 times daily (30 minutes before each meal and at bedtime) and limit the maximum daily dose to 20 mg if combined with strong CYP2D6 inhibitors. Risk D: Consider therapy modification

MetyroSINE: May enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Risk C: Monitor therapy

Mexiletine: Selective Serotonin Reuptake Inhibitors may decrease the metabolism of Mexiletine. Risk D: Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. While methylene blue and linezolid are expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to monographs specific to those agents for details. Exceptions: Linezolid; Methylene Blue; Tedizolid. Risk X: Avoid combination

Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Nebivolol: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Nebivolol. Risk C: Monitor therapy

Nicergoline: CYP2D6 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of Nicergoline. Specifically, concentrations of the MMDL metabolite may be increased. CYP2D6 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of Nicergoline. Specifically, concentrations of the MDL metabolite may be decreased. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Selective Serotonin Reuptake Inhibitors may enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Nonselective): Selective Serotonin Reuptake Inhibitors may enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Management: Consider using alternative analgesics, when appropriate, and/or addition of a gastroprotective agent. Monitor patients closely for signs/symptoms of bleeding, and for evidence of diminished SSRI effectiveness with concurrent use. Risk D: Consider therapy modification

Obinutuzumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased.Risk C: Monitor therapy

Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Opioid Agonists: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Panobinostat: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Risk C: Monitor therapy

Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Perhexiline: CYP2D6 Inhibitors may increase the serum concentration of Perhexiline. Management: Consider alternatives to this combination if possible. If combined, monitor for increased perhexiline serum concentrations and toxicities (eg, hypoglycemia, neuropathy, liver dysfunction). Perhexiline dose reductions will likely be required. Risk D: Consider therapy modification

Pimozide: Selective Serotonin Reuptake Inhibitors may enhance the adverse/toxic effect of Pimozide. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk X: Avoid combination

Pimozide: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Pimozide. Risk X: Avoid combination

Pitolisant: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Pitolisant. Risk C: Monitor therapy

Pravastatin: May enhance the adverse/toxic effect of PARoxetine. Specifically, blood glucose elevations may occur with the combination. Risk C: Monitor therapy

Primaquine: CYP2D6 Inhibitors (Strong) may diminish the therapeutic effect of Primaquine. Management: Monitor for signs and symptoms of possible treatment failure with primaquine in patients who are taking strong CYP2D6 inhibitors. If efficacy of primaquine is compromised, may consider adjusting therapies. Risk D: Consider therapy modification

Propafenone: PARoxetine may increase the serum concentration of Propafenone. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

QuiNINE: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Rivaroxaban: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Rivaroxaban. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Risk C: Monitor therapy

Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Risk C: Monitor therapy

Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Exceptions: Nicergoline; Tedizolid.Risk C: Monitor therapy

Serotonin Reuptake Inhibitor/Antagonists: Selective Serotonin Reuptake Inhibitors may enhance the serotonergic effect of Serotonin Reuptake Inhibitor/Antagonists. This may cause serotonin syndrome. Management: Consider alternatives, and use conservative initial dosing. Monitor patients receiving these combinations for signs/symptoms of serotonin toxicity. Risk D: Consider therapy modification

Tamoxifen: CYP2D6 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of Tamoxifen. Specifically, strong CYP2D6 inhibitors may decrease the metabolic formation of highly potent active metabolites. Risk X: Avoid combination

Tamsulosin: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Tamsulosin. Risk C: Monitor therapy

Tedizolid: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Tetrabenazine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Tetrabenazine. Specifically, concentrations of the active alpha- and beta-dihydrotetrabenazine metabolites may be increased. Management: Tetrabenazine adult dose should be reduced by 50% when starting a strong CYP2D6 inhibitor. Maximum tetrabenazine adult dose is 50 mg/day when used with a strong CYP2D6 inhibitor. Risk D: Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Selective Serotonin Reuptake Inhibitors may enhance the hyponatremic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Thioridazine: CYP2D6 Inhibitors may increase the serum concentration of Thioridazine. Risk X: Avoid combination

Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Risk C: Monitor therapy

Thyroid Products: Selective Serotonin Reuptake Inhibitors may diminish the therapeutic effect of Thyroid Products. Thyroid product dose requirements may be increased. Risk C: Monitor therapy

Timolol (Ophthalmic): CYP2D6 Inhibitors (Strong) may increase the serum concentration of Timolol (Ophthalmic). Risk C: Monitor therapy

TraMADol: CYP2D6 Inhibitors (Strong) may diminish the therapeutic effect of TraMADol. CYP2D6 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of TraMADol. CYP2D6 Inhibitors (Strong) may increase the serum concentration of TraMADol. Risk C: Monitor therapy

TraMADol: Serotonin Modulators may enhance the adverse/toxic effect of TraMADol. The risk of seizures may be increased. TraMADol may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Tricyclic Antidepressants: PARoxetine may enhance the adverse/toxic effect of Tricyclic Antidepressants. PARoxetine may increase the serum concentration of Tricyclic Antidepressants. Management: Consider alternatives to this combination when possible. Monitor for adverse effects of tricyclic antidepressants (TCAs), including serotonin syndrome and QT-interval prolongation, when a TCA is being used in combination with paroxetine. Risk D: Consider therapy modification

Tropisetron: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Tropisetron. Risk C: Monitor therapy

Tryptophan: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Risk X: Avoid combination

Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Risk X: Avoid combination

Valbenazine: CYP2D6 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of Valbenazine. Risk C: Monitor therapy

Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Selective Serotonin Reuptake Inhibitors may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Vortioxetine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Vortioxetine. Management: The vortioxetine dose should be reduced by 50% when used together with a strong CYP2D6 inhibitor. Following cessation of the strong CYP2D6 inhibitor, the vortioxetine dose should be returned to the normal level. Risk D: Consider therapy modification

Food Interactions

Peak concentration is increased, but bioavailability is not significantly altered by food. Management: Administer without regard to meals.

Monitoring Parameters

Serum sodium in at-risk populations (as clinically indicated); mental status for depression, suicide ideation (especially at the beginning of therapy or when doses are increased or decreased), anxiety, social functioning, mania, panic attacks; signs/symptoms of serotonin syndrome; akathisia

Advanced Practitioners Physical Assessment/Monitoring

Obtain serum sodium as needed in patients at risk for hyponatremia. Assess patient for signs of clinical worsening, suicide ideation, mania, hypomania, anxiety, or panic attacks. Assess for signs and symptoms of serotonin syndrome. Taper dosage slowly when discontinuing to avoid withdrawal syndrome. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed. Verify that female patients of childbearing age are not pregnant. Ensure proper use of birth control prior to therapy.

Nursing Physical Assessment/Monitoring

Check ordered labs and report abnormalities. Monitor for therapeutic effectiveness (mental status for depression, suicide ideation, social functioning, mania, or panic attacks). Check pregnancy status and educate patients of childbearing age on the importance of not becoming pregnant and reliable birth control while on this medicine. Monitor for signs of clinical worsening or hypomania. Instruct patient to taper dosage slowly when discontinuing. Instruct patient to determine if this drug makes them too sleepy to perform tasks that require mental alertness, such as driving or operating machinery. Educate patient on signs and symptoms of serotonin syndrome and to report any signs to healthcare provider.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as mesylate [strength expressed as base]:

Brisdelle: 7.5 mg [contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

Generic: 7.5 mg

Suspension, Oral, as hydrochloride [strength expressed as base]:

Paxil: 10 mg/5 mL (250 mL) [contains fd&c yellow #6 aluminum lake, methylparaben, propylene glycol, propylparaben, saccharin sodium; orange flavor]

Tablet, Oral, as hydrochloride [strength expressed as base]:

Paxil: 10 mg [scored]

Paxil: 10 mg [scored; contains fd&c blue #2 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Paxil: 20 mg [scored]

Paxil: 20 mg [scored; contains fd&c blue #2 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Paxil: 30 mg

Paxil: 30 mg [contains fd&c blue #2 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Paxil: 40 mg

Paxil: 40 mg [contains fd&c blue #2 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Generic: 10 mg, 20 mg, 30 mg, 40 mg

Tablet, Oral, as mesylate [strength expressed as base]:

Pexeva: 10 mg, 20 mg

Pexeva: 20 mg [DSC] [scored]

Pexeva: 30 mg, 40 mg

Tablet Extended Release 24 Hour, Oral, as hydrochloride [strength expressed as base]:

Paxil CR: 12.5 mg [contains fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Paxil CR: 25 mg

Paxil CR: 37.5 mg [contains fd&c blue #2 aluminum lake]

Generic: 12.5 mg, 25 mg, 37.5 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral, as hydrochloride [strength expressed as base]:

Paxil: 10 mg, 20 mg, 30 mg [contains POLYSORBATE 80]

Generic: 10 mg, 20 mg, 30 mg, 40 mg

Tablet Extended Release 24 Hour, Oral, as hydrochloride [strength expressed as base]:

Paxil CR: 12.5 mg [contains FD&C YELLOW #10 ALUMINUM LAKE, FD&C YELLOW #6 ALUMINUM LAKE, POLYSORBATE 80]

Paxil CR: 25 mg [contains POLYSORBATE 80]

Paxil CR: 37.5 mg [DSC] [contains FD&C BLUE #2 (INDIGOTINE), POLYSORBATE 80]

Anatomic Therapeutic Chemical (ATC) Classification
  • N06AB05
Generic Available (US)

May be product dependent

Pricing: US

Capsules (Brisdelle Oral)

7.5 mg (per each): $8.28

Capsules (PARoxetine Mesylate Oral)

7.5 mg (per each): $6.60

Suspension (Paxil Oral)

10 mg/5 mL (per mL): $1.54

Tablet, 24-hour (PARoxetine HCl ER Oral)

12.5 mg (per each): $2.40 – $5.58

25 mg (per each): $2.52 – $5.82

37.5 mg (per each): $2.64 – $5.99

Tablet, 24-hour (Paxil CR Oral)

12.5 mg (per each): $7.61

25 mg (per each): $7.95

37.5 mg (per each): $8.19

Tablets (PARoxetine HCl Oral)

10 mg (per each): $0.07 – $2.67

20 mg (per each): $0.07 – $2.92

30 mg (per each): $0.10 – $2.83

40 mg (per each): $0.11 – $3.00

Tablets (Paxil Oral)

10 mg (per each): $7.39

20 mg (per each): $7.71

30 mg (per each): $7.95

40 mg (per each): $8.40

Tablets (Pexeva Oral)

10 mg (per each): $14.34

20 mg (per each): $14.91

30 mg (per each): $15.48

40 mg (per each): $16.05

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

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

Pharmacodynamics/Kinetics

Onset of action: Depression: The onset of action is within a week; however, individual response varies greatly and full response may not be seen until 8 to 12 weeks after initiation of treatment; antiobsessional and antipanic effects: Up to several weeks

Absorption: Completely absorbed following oral administration

Distribution: Vd: 8.7 L/kg (3 to 28 L/kg)

Protein binding: 93% to 95%

Metabolism: Extensively hepatic via CYP2D6 enzymes; primary metabolites are formed via oxidation and methylation of parent drug, with subsequent glucuronide/sulfate conjugation; nonlinear pharmacokinetics (via 2D6 saturation) may be seen with higher doses and longer duration of therapy. Metabolites exhibit ~2% potency of parent compound. Cminconcentrations are 70% to 80% greater in the elderly compared to nonelderly patients; clearance is also decreased.

Bioavailability: Immediate release tablet and oral suspension have equal bioavailability

Half-life elimination: Paxil: 21 hours; Paxil CR: 15 to 20 hours; Pexeva: 33.2 hours

Time to peak:

Capsules: Median: 6 hours (range: 3 to 8 hours)

Tablets, oral suspension: Immediate release: Mean: 5.2 to 8.1 hours

Tablets: Controlled release: 6 to 10 hours

Excretion: Urine (64%, 2% as unchanged drug); feces (36% primarily via bile, <1% as unchanged drug)

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Mean plasma concentrations increased approximately 4 times, with CrCl <30 mL/minute. Plasma concentrations increased 2-fold with CrCl 30 to 60 mL/minute.

Hepatic function impairment: 2-fold increase in plasma concentrations; reduce the dose in patients with severe hepatic impairment; no dosage adjustment is necessary with Brisdelle.

Geriatric: Minimum concentrations were 70% to 80% greater than in younger patients. Reduce initial dosage; no dosage adjustment is necessary with Brisdelle.

Local Anesthetic/Vasoconstrictor Precautions

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; no precautions appear to be needed

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation), and abnormal taste. Patients may experience orthostatic hypotension as they stand up after treatment; especially if lying in dental chair for extended periods of time. Use caution with sudden changes in position during and after dental treatment. Problems with SSRI-induced bruxism have been reported and may preclude their use; clinicians attempting to evaluate any patient with bruxism or involuntary muscle movement, who is simultaneously being treated with an SSRI drug, should be aware of the potential association. Prolonged use may decrease or inhibit salivary flow; normal salivation resumes upon discontinuation. See Effects on Bleeding.

Effects on Bleeding

May impair platelet aggregation resulting in increased risk of bleeding events, particularly if used concomitantly with aspirin, NSAIDs, warfarin, or other anticoagulants. Bleeding related to SSRI use has been reported to range from relatively minor bruising and epistaxis to life-threatening hemorrhage. Routine interruption of therapy for most dental procedures is not warranted. In medically complicated patients or extensive oral surgery, the decision to interrupt therapy must be based on the risk to benefit in an individual patient and a medical consult is suggested. If therapy is continued without interruption, the clinician should anticipate the potential for a prolonged bleeding time.

Index Terms

Paroxetine HCl; Paroxetine Hydrochloride; Paroxetine Mesylate

FDA Approval Date
December 29, 1992
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Brand Names: International

A-Xat CR (KR); Afentan (LK); Arapaxel (ES); Arketis (CZ, LV, MT, RO); Aropax (LU, MX, ZW); Aropax 20 (AR, AU, BE, BR, NZ, PY, UY, ZA); Aroxat (CL); Dapagut (IT); Daparox (ES); Depanx (EG); Deprox (LB); Deroxat (CH, FR); Divarius (FR); Ennos (AT); Euplix (DK); Extine (AU); Harotin 10 (VN); Harotin 20 (VN); Harotin 40 (VN); Loxamine (NZ); Melev (BD); Olane (PY); Oxat (BD, LK); Paluxon (HR); Pari (LK); PARI CR (IN); Parmite (NL); Paroket (BD); Parolex (CZ); Paroser (IE); Paroten (EC); Parotin (BD, HK, IL); Parox (IE); Paroxat (JO, KW, QA, SA); Paroxil CR (KR); Paroxin (UA); Paxan (CO); Paxetil (KR); Paxetin (EG); Paxil (BB, BM, BS, BZ, CR, CU, DO, EC, GT, GY, HN, JM, MX, NI, PA, PR, RU, SR, SV, TR, TT, UA, VE); Paxil CR (BB, BM, BS, BZ, CR, DO, EC, GT, GY, HN, JM, KR, MX, NI, PA, PR, SR, SV, TT); Paxitab (BH, LB, QA); Paxtine (AU); Paxxet (IL); Rexsetin (UA); Roxet (AU); Seretran (EC); Seretran CR (EC); Seroxat (AE, AT, BD, BF, BH, BJ, CI, CN, CO, CY, CZ, DE, DK, EE, ES, ET, FI, GB, GH, GM, GN, GR, HK, HR, HU, ID, IE, IL, IQ, IR, IS, IT, JO, JP, KE, KR, KW, LB, LR, LT, LU, LV, LY, MA, ML, MR, MT, MU, MW, MY, NE, NG, NL, NO, OM, PE, PH, PK, PL, PT, QA, RO, SA, SC, SD, SE, SG, SI, SK, SL, SN, SY, TH, TN, TW, TZ, UG, YE, ZM, ZW); Seroxat CR (AE, BH, CN, EG, HK, JO, KW, QA, SA, SG, TH); Seroxate (EG); Setine (TW); Sumiko (VN); Tagonis (DE); Tiarix (PY); Unirox (BH, JO); Xalexa (VN); Xandol (EG); XET (TW); Xet 20 (PH); Xetanor (BG); Xetine-P (TW)

Paroxetine (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(pa ROKS e teen)

Brand Names: US

Brisdelle; Paxil; Paxil CR; Pexeva

Brand Names: Canada

Paxil; Paxil CR

Warning
  • Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
  • This drug is not approved for use in children. Talk with the doctor.
What is this drug used for?
  • It is used to treat low mood (depression).
  • It is used to treat obsessive-compulsive problems.
  • It is used to treat panic attacks.
  • It is used to treat social anxiety problems.
  • It is used to treat anxiety.
  • It is used to treat post-traumatic stress.
  • It is used to treat mood problems caused by monthly periods.
  • It is used to treat hot flashes caused by menopause.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • For all uses of this drug:
  • If you have an allergy to paroxetine or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Linezolid, methylene blue, pimozide, or thioridazine.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • For treating hot flashes caused by menopause:
  • If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this drug affects you.
  • Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
  • Avoid drinking alcohol while taking this drug.
  • Talk with your doctor before you use other drugs and natural products that slow your actions.
  • It may take several weeks to see the full effects.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • This drug may raise the chance of a broken bone. Talk with the doctor.
  • This drug may raise the chance of bleeding. Sometimes, bleeding can be life-threatening. Talk with the doctor.
  • Some people may have a higher chance of eye problems with this drug. Your doctor may want you to have an eye exam to see if you have a higher chance of these eye problems. Call your doctor right away if you have eye pain, change in eyesight, or swelling or redness in or around the eye.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this drug with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • This drug can cause low sodium levels. Very low sodium levels can be life-threatening, leading to seizures, passing out, trouble breathing, or death. Talk with the doctor.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • This drug may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Feeling confused.
  • Change in balance.
  • Agitation, twitching, sweating, or muscle stiffness.
  • Very nervous and excitable.
  • A heartbeat that does not feel normal.
  • Hallucinations (seeing or hearing things that are not there).
  • Very bad dizziness or passing out.
  • Bone pain.
  • Seizures.
  • A big weight loss.
  • Restlessness.
  • A burning, numbness, or tingling feeling that is not normal.
  • Sex problems like lowered interest in sex or ejaculation problems.
  • Erection that lasts more than 4 hours.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Dizziness.
  • Feeling sleepy.
  • Feeling nervous and excitable.
  • Headache.
  • Upset stomach or throwing up.
  • Constipation.
  • Diarrhea.
  • Dry mouth.
  • Not able to sleep.
  • Feeling tired or weak.
  • Not hungry.
  • Shakiness.
  • Yawning.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Take with or without food.
  • Liquid (suspension):
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Tablet:
  • Swallow whole. Do not chew, break, or crush.
  • Capsule:
  • Take this drug at bedtime.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Paroxetine (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(pa ROKS e teen)

Brand Names: US

Brisdelle; Paxil; Paxil CR; Pexeva

Brand Names: Canada

Paxil; Paxil CR

Warning
  • Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
  • This drug is not approved for use in children. Talk with the doctor.
What is this drug used for?
  • It is used to treat low mood (depression).
  • It is used to treat obsessive-compulsive problems.
  • It is used to treat social anxiety problems.
  • It is used to treat panic attacks.
  • It is used to treat anxiety.
  • It is used to treat post-traumatic stress.
  • It may be given to your child for other reasons. Talk with the doctor.
  • If your child has menstrual periods:
  • It is used to treat mood problems caused by monthly periods.
  • Capsules:
  • If your child has been given this form of this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is taking any of these drugs: Linezolid, methylene blue, pimozide, or thioridazine.
  • If your child has taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for certain other health problems in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of side effects. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Talk with your child’s doctor before giving your child other drugs and natural products that may slow your child’s actions.
  • It may take several weeks to see the full effects.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • This drug may raise the chance of a broken bone. Talk with the doctor.
  • This drug may raise the chance of bleeding. Sometimes, bleeding can be life-threatening. Talk with the doctor.
  • Some people may have a higher chance of eye problems with this drug. The doctor may want your child to have an eye exam to see if your child has a higher chance of these eye problems. Call the doctor right away if your child has eye pain, change in eyesight, or swelling or redness in or around the eye.
  • This drug can cause low sodium levels. Very low sodium levels can be life-threatening, leading to seizures, passing out, trouble breathing, or death. Talk with the doctor.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • This drug may affect sperm in males. This may affect being able to father a child later in life. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • If your child is planning to harm him/herself. If the want to harm him/herself gets worse.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Change in the way your child acts.
  • Feeling confused.
  • Change in balance.
  • Agitation, twitching, sweating, or muscle stiffness.
  • Very nervous and excitable.
  • A heartbeat that does not feel normal.
  • Hallucinations (seeing or hearing things that are not there).
  • Very bad dizziness or passing out.
  • Bone pain.
  • Seizures.
  • A big weight loss.
  • Restlessness.
  • A burning, numbness, or tingling feeling that is not normal.
  • Erection that lasts more than 4 hours.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call your child’s doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; a fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • If your child is or may be sexually active:
  • Sex problems like lowered interest in sex or ejaculation problems.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Dizziness.
  • Feeling sleepy.
  • Headache.
  • Upset stomach or throwing up.
  • Constipation.
  • Diarrhea.
  • Feeling nervous and excitable.
  • Dry mouth.
  • Not able to sleep.
  • Feeling tired or weak.
  • Sweating a lot.
  • Not hungry.
  • Shakiness.
  • Yawning.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Give this drug with or without food.
  • Liquid (suspension):
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Tablet:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.