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Paroxetine

Generic Name: paroxetine (pa ROX a teen)
Brand Names: Brisdelle, Paxil, Paxil CR, Pexeva

What is paroxetine?

Paroxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paroxetine affects chemicals in the brain that may be unbalanced in people with depression, anxiety, or other disorders.

Paroxetine is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

The Brisdelle brand of paroxetine is used to treat hot flashes related to menopause. Brisdelle is not for treating any other conditions.

Paroxetine may also be used for purposes not listed in this medication guide.

Important information

You should not use paroxetine if you are also taking pimozide or thioridazine.

Do not use paroxetine within 14 days before or 14 days after you have used a MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not start or stop taking paroxetine during pregnancy without your doctor's advice.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor

Seek medical attention right away if you have symptoms such as: agitation, hallucinations, muscle stiffness, twitching, loss of coordination, dizziness, warmth or tingly feeling, nausea, vomiting, diarrhea, fever, sweating, tremors, racing heartbeats, or a seizure (convulsions).

Before taking this medicine

You should not use this medicine if you are allergic to paroxetine, or if you are also taking pimozide or thioridazine.

Do not use an MAO inhibitor within 14 days before or 14 days after you take paroxetine. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking paroxetine you must wait at least 14 days before you start taking an MAO inhibitor.

To make sure paroxetine is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, history of stroke;

  • liver or kidney disease;

  • a bleeding or blood clotting disorder;

  • seizures or epilepsy;

  • bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts;

  • narrow-angle glaucoma; or

  • low levels of sodium in your blood.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking paroxetine during pregnancy may cause serious lung problems, a heart defect, or other complications in the baby. However, you may have a relapse of depression or other treated condition if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking paroxetine during pregnancy without your doctor's advice.

Do not use Brisdelle if you are pregnant.

Paroxetine can pass into breast milk and may cause side effects in the nursing baby. You should not breast-feed while using this medicine.

Paroxetine is not approved for use by anyone younger than 18 years old.

How should I take paroxetine?

Take paroxetine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, or break an extended-release paroxetine tablet. Swallow it whole.

Shake the paroxetine oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using paroxetine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using paroxetine. Follow your doctor's instructions about tapering your dose.

Store paroxetine at room temperature away from moisture, heat, and light.

Dosage Information (comprehensive)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of paroxetine can be fatal.

What should I avoid while taking paroxetine?

Drinking alcohol with paroxetine can cause side effects.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with paroxetine may cause you to bruise or bleed easily.

Paroxetine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Paroxetine side effects

Get emergency medical help if you have signs of an allergic reaction to paroxetine: skin rash or hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;

  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

  • unusual bone pain or tenderness, swelling or bruising;

  • changes in weight or appetite;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;

  • high levels of serotonin in the body - agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

  • low levels of sodium in the body - headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady;

  • severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting; or

  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common paroxetine side effects may include:

  • vision changes;

  • weakness, drowsiness, dizziness;

  • sweating, anxiety, shaking;

  • sleep problems (insomnia);

  • loss of appetite, constipation;

  • dry mouth, yawning; or

  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects (complete list)

Paroxetine dosing information

Usual Adult dose of Paroxetine for Depression:

Immediate-release tablets and suspension:
Initial dose: 20 mg orally once a day
Maintenance dose: 20 to 50 mg orally once a day
Maximum dose: 50 mg orally once a day

Controlled-release tablets:
Initial dose: 25 mg orally once a day
Maintenance dose: 25 to 62.5 mg orally once a day
Maximum dose: 62.5 mg orally once a day

Duration: Acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy; systemic evaluation has shown that efficacy was maintained for up to one year.

Comments:
-Immediate-release oral formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability
-Extended-release oral formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability
-Efficacy of up to one year was demonstrated with a daily dose averaging 30 mg for the immediate-release formulations and 37.5 mg for the controlled-release formulation

Use: Treatment of Major Depressive Disorder

Usual Adult Dose of Paroxetine for Social Anxiety Disorder:

Immediate-release tablets and suspension:
Initial dose: 20 mg orally once a day
Maintenance dose: 20 to 60 mg orally once a day
Maximum dose: 60 mg orally once a day

Controlled-release tablets:
Initial dose: 12.5 mg orally once a day
Maintenance dose: 12.5 to 37.5 mg orally once a day

Duration: Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients

Comments:
-Immediate-release oral formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability
-Extended-release oral formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability

Usual Adult Dose of Paroxetine for Panic Disorder:

Immediate-release tablets and suspension:
Initial dose: 10 mg orally once a day
Maintenance dose: 10 to 40 mg orally once a day
Maximum dose: 60 mg orally once a day

Controlled-release oral tablets:
Initial dose: 12.5 mg orally once a day
Maintenance dose: 12.5 to 75 mg orally once a day
Maximum dose: 75 mg orally once a day

Duration: Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients

Comments:
-Immediate-release oral formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability
-Extended-release oral formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability
-The target dose is 40 mg once a day

Usual Adult Dose of Paroxetine for Premenstrual Dysphoric Disorder:

Controlled-release tablets:
Continuous regimen:
Initial dose: 12.5 mg orally once a day during the menstrual cycle
Maintenance dose: 25 mg orally once a day during the menstrual cycle

Cyclic regimen:
Initial dose: 12.5 mg orally once a day, starting 14 days prior to the anticipated start of menstruation through to the first full day of menses, and repeated with each new cycle
Maintenance dose: 12.5 to 25 mg orally once a day

Duration: Efficacy has been demonstrated for up to 3 menstrual cycles; continuation of treatment beyond this time may be considered in responding patients

Comments:
-The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability

Usual Adult Dose of Paroxetine for Obsessive Compulsive Disorder:

Immediate-release tablets and suspension:
Initial dose: 20 mg orally once a day
Maintenance dose: 20 to 60 mg orally once a day
Maximum dose: 60 mg orally once a day
Duration: Efficacy has been demonstrated for up to 6 months; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients

Comments:
-The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability
-The target dose is 40 mg once a day

Usual Adult Dose of Paroxetine for Post Traumatic Stress Disorder:

Immediate-release tablets and suspension:
Initial dose: 20 mg orally once a day
Maintenance dose: 20 to 50 mg orally once a day
Maximum dose: 50 mg orally once a day
Duration:
-Generalized Anxiety Disorder: Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8 week treatment phase
-Posttraumatic Stress Disorder: Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients

Comments:
-The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability

Usual Adult Dose of Paroxetine for Generalized Anxiety Disorder:

Immediate-release tablets and suspension:
Initial dose: 20 mg orally once a day
Maintenance dose: 20 to 50 mg orally once a day
Maximum dose: 50 mg orally once a day
Duration:
-Generalized Anxiety Disorder: Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8 week treatment phase
-Posttraumatic Stress Disorder: Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients

Comments:
-The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability

Usual Adult Dose of Paroxetine for Postmenopausal Symptoms:

Recommended dose: 7.5 mg orally once a day

Use: Treatment of moderate to severe vasomotor symptoms associated with menopause (Brisdelle (R))

Usual Geriatric Dose of Paroxetine for Obsessive Compulsive Disorder:

Immediate-release tablets and suspension:
Initial dose: 10 mg orally once a day
Maintenance dose: 10 to 40 mg orally once a day
Maximum dose: 40 mg orally once a day
Duration:
-Generalized Anxiety Disorder: Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8 week acute treatment phase
-Obsessive Compulsive Disorder: Efficacy has been demonstrated for up to 6 months; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients
-Posttraumatic Stress Disorder and Social Anxiety Disorder: Efficacy has been demonstrated for up to 12 weeks being a chronic condition, continuation of treatment beyond this time may be considered in responding patients

Comments:
-The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability

Usual Geriatric Dose of Paroxetine for Post Traumatic Stress Disorder:

Immediate-release tablets and suspension:
Initial dose: 10 mg orally once a day
Maintenance dose: 10 to 40 mg orally once a day
Maximum dose: 40 mg orally once a day
Duration:
-Generalized Anxiety Disorder: Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8 week acute treatment phase
-Obsessive Compulsive Disorder: Efficacy has been demonstrated for up to 6 months; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients
-Posttraumatic Stress Disorder and Social Anxiety Disorder: Efficacy has been demonstrated for up to 12 weeks being a chronic condition, continuation of treatment beyond this time may be considered in responding patients

Comments:
-The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability

Usual Geriatric Dose of Paroxetine for Social Anxiety Disorder:

Immediate-release tablets and suspension:
Initial dose: 10 mg orally once a day
Maintenance dose: 10 to 40 mg orally once a day
Maximum dose: 40 mg orally once a day
Duration:
-Generalized Anxiety Disorder: Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8 week acute treatment phase
-Obsessive Compulsive Disorder: Efficacy has been demonstrated for up to 6 months; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients
-Posttraumatic Stress Disorder and Social Anxiety Disorder: Efficacy has been demonstrated for up to 12 weeks being a chronic condition, continuation of treatment beyond this time may be considered in responding patients

Comments:
-The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability

Usual Geriatric Dose of Paroxetine for Generalized Anxiety Disorder:

Immediate-release tablets and suspension:
Initial dose: 10 mg orally once a day
Maintenance dose: 10 to 40 mg orally once a day
Maximum dose: 40 mg orally once a day
Duration:
-Generalized Anxiety Disorder: Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8 week acute treatment phase
-Obsessive Compulsive Disorder: Efficacy has been demonstrated for up to 6 months; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients
-Posttraumatic Stress Disorder and Social Anxiety Disorder: Efficacy has been demonstrated for up to 12 weeks being a chronic condition, continuation of treatment beyond this time may be considered in responding patients

Comments:
-The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability

Usual Geriatric Dose of Paroxetine for Depression:

Immediate-release tablets and suspension:
Initial dose: 10 mg orally once a day
Maintenance dose: 10 to 40 mg orally once a day
Maximum dose: 40 mg orally once a day

Controlled-release tablets:
Initial dose: 12.5 mg orally once a day
Maintenance dose: 12.5 to 50 mg orally once a day
Maximum dose: 50 mg orally once a day

Duration:
-Major Depressive Disorder: Acute episodes require several months or longer of sustained pharmacologic therapy; systemic evaluation has shown that efficacy was maintained for up to one year
-Panic Disorder: Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment may be considered in responding patients

Comments:
-Immediate-release oral formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability
-Controlled-release oral formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability
-Efficacy of up to one year was demonstrated with a daily dose averaging 30 mg for the immediate-release formulation and 37.5 mg for the controlled-release formulation

Uses: Treatment of Major Depressive Disorder and Panic Disorder

Usual Geriatric Dose of Paroxetine for Panic Disorder:

Immediate-release tablets and suspension:
Initial dose: 10 mg orally once a day
Maintenance dose: 10 to 40 mg orally once a day
Maximum dose: 40 mg orally once a day

Controlled-release tablets:
Initial dose: 12.5 mg orally once a day
Maintenance dose: 12.5 to 50 mg orally once a day
Maximum dose: 50 mg orally once a day

Duration:
-Major Depressive Disorder: Acute episodes require several months or longer of sustained pharmacologic therapy; systemic evaluation has shown that efficacy was maintained for up to one year
-Panic Disorder: Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment may be considered in responding patients

Comments:
-Immediate-release oral formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability
-Controlled-release oral formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability
-Efficacy of up to one year was demonstrated with a daily dose averaging 30 mg for the immediate-release formulation and 37.5 mg for the controlled-release formulation

Uses: Treatment of Major Depressive Disorder and Panic Disorder

What other drugs will affect paroxetine?

Taking paroxetine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • cimetidine (Tagamet), St. John's wort, tamoxifen, tryptophan (sometimes called L-tryptophan), warfarin (Coumadin, Jantoven);

  • heart rhythm medicine;

  • HIV or AIDS medications;

  • certain medicines to treat narcolepsy or ADHD - amphetamine, atomoxetine, dextroamphetamine, Adderall, Dexedrine, Evekeo, Vyvanse, and others;

  • narcotic pain medicine - fentanyl, tramadol;

  • medicine to treat anxiety, mood disorders, thought disorders, or mental illness - such as buspirone, lithium, other antidepressants, or antipsychotics;

  • migraine headache medicine - sumatriptan, rizatriptan, zolmitriptan, and others; or

  • seizure medicine - phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with paroxetine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about paroxetine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use paroxetine only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Cerner Multum, Inc. Version: 26.01.

Date modified: June 09, 2017
Last reviewed: May 08, 2017

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