When to take paxil?

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Paxil

Paxil is the brand name for the antidepressant paroxetine.

Though doctors prescribe Paxil to treat depression, it’s also used to treat anxiety disorders including:

  • Panic disorder
  • Social anxiety disorder
  • Generalized anxiety disorder (GAD)
  • Post-traumatic stress disorder (PTSD)
  • Obsessive-compulsive disorder (OCD)

Paxil is also approved by Food and Drug Administration (FDA) to help women manage the hot flashes associated with menopause.

Additionally, doctors may prescribe Paxil off-label to treat conditions other than those for which it has been approved by the FDA.

For example, some doctors prescribe Paxil to treat chronic headaches, and people with diabetes may use the drug to help alleviate tingling in the hands and feet.

Paxil has also been used to treat men who experience premature ejaculation.

A controlled-release form, Paxil CR, can relieve the physical and psychological symptoms some women experience before their menstrual cycle begins each month.

Paxil belongs to a class of antidepressant medications called selective serotonin-reuptake inhibitors (SSRIs).

SSRIs work by boosting levels of serotonin, a neurotransmitter that helps the brain send messages from one nerve cell to another.

Paxil History

GlaxoSmithKline makes Paxil, which the FDA first approved in 2001.

Paxil is also available under the brand names Brisdelle and Pexeva. Generic forms of paroxetine became available in 2003.

GlaxoSmithKline has repeatedly come under fire for its marketing of Paxil and other antidepressants, including accusations that the company misreported data from clinical trials, which showed that Paxil might be unsafe for teenagers and young adults.

In 2012, GlaxoSmithKline agreed to pay a $3 billion fine to U.S. federal prosecutors, in part for its antidepressant marketing practices.

A study published in the medical journal BMJ in 2015 reanalyzed data from 2001 and found that Paxil was ineffective at treating depression in adolescents.

Additionally, the study found that use of the drug among adolescents was associated with significant harm, including thoughts of suicide and suicide attempts.

Paxil Warnings

Paxil and other antidepressants are required to carry a black-box warning because of an increased risk of suicide.

A growing body of research shows that some children, teens, and young adults who take an antidepressant drug such as Paxil often develop suicidal thoughts or actions.

Young people up to age 24 who take these medications for the treatment of depression or another mental illness have a high risk of suicidal thoughts and behaviors.

In some cases, a doctor may determine that the drug is appropriate for someone younger than 18.

Children who take paroxetine could lose weight, so their doctor should closely monitor their growth while they are taking the medication.

Adults taking Paxil to treat depression or mental illness may also experience unexpected changes in their behavior or mental state.

Women taking low doses of the drug to ease the discomfort of hot flashes may also change in their behavior or mental state, even if they have never had depression or another mental illness.

People taking Paxil are more likely to become suicidal when they first start taking the medication and whenever their dose of the drug is increased.

A 2014 study found that Paxil acts as an estrogen promoter, which could have implications for women with estrogen-sensitive (estrogen-receptor positive) breast cancer.

The research also found that Paxil could reduce the effectiveness of the breast cancer drug tamoxifen.

Tell your doctor if you have ever had glaucoma or seizures. It’s also important to tell your doctor if you have:

  • Bleeding from your stomach or esophagus
  • Liver disease
  • Kidney problems
  • Heart disease
  • A recent heart attack

Let your doctor know about any herbal products or dietary supplements you take, particularly St. John’s wort (which may also boost serotonin levels), and make sure your doctor knows if you have any type of surgery planned, including dental surgery.

Tell your doctor if you use or have ever used illegal or recreational drugs or abused prescription medications. Your doctor may also test you to see if you have a low level of sodium in your blood.

Paxil Withdrawal

People who use Paxil (or another antidepressant) may experience withdrawal symptoms when they stop taking the drug.

Symptoms of Paxil withdrawal include:

  • Dizziness and vertigo
  • Nausea
  • Flu-like symptoms
  • Confusion and anxiety
  • Insomnia
  • Irritability

Your doctor will probably advise that you gradually reduce or “taper-off” your use of Paxil. Quitting “cold turkey” is usually associated with a higher risk of withdrawal symptoms.

Talk with your doctor about the best way to reduce or stop your use of Paxil or any other drug.

Paxil and Pregnancy

Let your doctor know if you are pregnant, might become pregnant, or are breastfeeding before taking Paxil.

Pregnant women should not take Paxil, particularly in early pregnancy and during the last few months of pregnancy. The drug may cause heart defects in unborn babies and has been linked to other health problems in newborns.

If you’re breastfeeding a baby, talk with your doctor before taking Paxil because the drug may affect the quality of your breast milk.

About the Antidepressant Paroxetine (Paxil, Seroxat)

Paroxetine is the generic name for a popular antidepressant medication, which is most commonly found under the brand names Paxil and Seroxat. The medication is most often used to treat all types of depression as well as social anxiety disorder and panic disorder. In some cases, paroxetine is prescribed to treat obsessive-compulsive disorder and post-traumatic stress disorder. Recently, the Food and Drug Administration (FDA) approved paroxetine to treat hot flashes in menopausal women; this is the first non-hormone medication used in this type of treatment.
As a selective serotonin reuptake inhibitor (SSRI), paroxetine is one of the many medications that treats mood disorders by preventing some serotonin, a neurotransmitter associated with happiness, from being absorbed by neurons. This enhances neuron-firing.

Who Makes Paroxetine Drugs, and How Are They Prescribed?

The most common brand names containing paroxetine are Paxil and Seroxat; however, other popular brands include Pexeva or Brisdelle. GlaxoSmithKline manufactures Paxil, which was approved by the FDA in 2001. Paroxetine as a generic drug was approved for prescription use in the US in 2003.

Paroxetine can be found as a tablet, controlled-release tablet, capsule, and suspension/liquid. The capsules are typically prescribed to be taken twice per day, or every 12 hours; the other formats are usually ingested once per day.

Paxil is typically found in tablet doses of 10, 20, 30, and 40 mg. The liquid suspension comes in a dose of 10 mg per 5 mL. Paxil CR is found in doses of 12.5, 25, and 37.5 mg. Pexeva comes in doses of 10, 20, 30, and 40 mg.

People who receive paroxetine to treat major depressive disorder typically receive a prescription for 20 mg once per day, and that dose can be increased over time as needed, although it should not exceed 50 mg. Those with obsessive-compulsive disorder also take this medication once per day, but their initial target dose is 40 mg and should not exceed 60 mg per day. People with panic disorder receive a similar dose, while social anxiety disorder is treated more like major depression.

Regardless of the mental health condition involved, no one should take paroxetine medications without a prescription. It is important not to make any dose adjustments without consulting a doctor, although some people with some conditions, such as major depression, may be able to temporarily lower their dose before seeing their physician if they find the side effects are too intense. In all cases, individuals should consult their doctor, at least via phone, prior to making any changes.
Further Reading

  • Effective Antidepressants to Treat Depression
  • Medicinal vs. Holistic Treatment for Depression
  • Understand Seasonal Affective Disorder (SAD)
  • Common Questions about Postpartum Depression and Treatment
  • Comparing Bereavement or Grief to Medical Depression
  • How Is a Major Depressive Disorder Different from Everyday Depression?

Withdrawal from Paroxetine

People who take paroxetine antidepressants, whether as prescribed or for nonmedical reasons, may wish at some point to stop taking them. Even if the person takes paroxetine as prescribed, they may experience withdrawal symptoms because their body has developed a dependence on the medication to manage serotonin levels. Withdrawal symptoms include:

  • Vertigo
  • Dizziness
  • Confusion
  • Anxiety
  • Nausea
  • Irritability or mood swings
  • Insomnia

With the help of a physician, a person can taper their dose of paroxetine until their body is no longer dependent on it. Attempting to stop taking the drug “cold turkey” is more likely to lead to withdrawal symptoms. About 7 percent of people who take paroxetine are likely to experience withdrawal symptoms, so it is important to work with a doctor.

Without a taper, withdrawal symptoms begin between 24 and 48 hours after the final dose and continue for about one week. The majority of symptoms resolve after two or three weeks, although in some rare cases, the person can develop a protracted withdrawal syndrome.

Side Effects

There are several side effects associated with paroxetine. These include both mental or emotional and physical side effects.

Physical side effects include:

  • Headache
  • Dizziness
  • Weakness, especially in muscles
  • Sleepiness, fatigue, or feeling “drugged”
  • Nausea and vomiting
  • Diarrhea
  • Constipation
  • Stomach pain
  • Heartburn
  • Changes in how food tastes
  • Dry mouth
  • Excessive sweating
  • Yawning
  • Sensitivity to light
  • Tightness in throat, or feeling a lump in the throat
  • Pain in muscles, back, or bones
  • Joint pain and swelling
  • Flushing
  • Sore teeth and gums

Mental side effects include:

  • Trouble concentrating
  • Nervousness or anxiety
  • Forgetfulness
  • Confusion
  • Difficulty sleeping
  • Nightmares or strange dreams

Medications containing paroxetine have a black box warning in the United States due to the potential for increased suicidal thinking among those who take this prescription. While paroxetine and its brand names have consistently been effective in treating depression in adults, a study published in the British Medical Journal in 2015, which involved analyzing over a decade’s worth of medical data on the SSRI, found that paroxetine was not effective in treating depression in adolescents and children. Those under the age of 24, the study found, tended to experience an increase in suicidal thinking while not experiencing enough relief from their depression.

Some people do not experience relief from symptoms of depression; instead, they may develop deepening or worsening depression. This is a very serious side effect, and if a person experiences this, they should immediately speak with their doctor.

Overdose from Paroxetine

When a doctor monitors an individual’s prescription, it is unlikely that the person will overdose. However, it is possible to take too much paroxetine. Overdose symptoms include:

  • Drowsiness or being unable to stay awake
  • Uncontrollable shaking or tremors
  • Changes in heart rate, either faster or slower
  • Extreme confusion
  • Nausea and vomiting
  • Fainting
  • Blurred vision
  • Loss of appetite
  • Unusual bruising or bleeding
  • Trouble walking, as though one is drunk
  • Fever
  • Sweating
  • Abnormally excited mood
  • Difficulty urinating
  • Muscle twitching or jerking
  • Aggressive or violent behaviors
  • Yellowing of the skin or eyes (jaundice)
  • Flu-like symptoms

Interactions with Other Drugs

Because paroxetine is a potent prescription medication, it can interact with other drugs. One of the most serious interactions is between paroxetine and other antidepressants, including other SSRIs, SNRIs, MAO inhibitors, and tricyclic antidepressants. Combining these medications, or taking more than the prescribed dose of paroxetine, can lead to serotonin syndrome. This condition involves too much serotonin in the brain, which can lead to agitation, anxiety, rapid and irregular heartbeat, high fever, seizures, and unconsciousness.

Other drugs that paroxetine can interact with include:

  • Blood thinners, especially warfarin
  • Medications that treat irregular heartbeat
  • Anti-nausea medications
  • Anti-seizure drugs
  • Antihistamines
  • Aspirin
  • Diuretic pills
  • Codeine
  • Drugs that treat gastrointestinal disorders
  • Some antibiotics
  • Atomoxetine, a medication to treat ADHD
  • Some HIV drugs
  • Anti-anxiety drugs
  • Drugs used to treat other mental health issues, such as bipolar disorder or schizophrenia
  • Antifungal medications
  • Opioid pain medications
  • Tamoxifen, which is used to treat breast cancer

Side effects from paroxetine can be more intense if a person drinks alcohol while taking this medication. Physicians and therapists will recommend limiting the amount of alcohol a person drinks while they take paroxetine.

Paroxetine’s Interactions with Physical Conditions

If a woman taking paroxetine is pregnant or breastfeeding, the antidepressant may affect her child. Taking paroxetine medications throughout pregnancy, especially in the last trimester, has been linked to some heart defects in newborns and to other health problems in infancy during breastfeeding. These issues are rare, but a woman who is pregnant or thinking of becoming pregnant while taking paroxetine should consult her doctor about the risks. Ultimately, it is up to the woman and her physician to decide whether it is psychologically safe for the woman to stop taking antidepressants or to switch her medication.

Other conditions that may interfere with paroxetine’s effectiveness or that can be made worse by taking paroxetine include:

  • Bipolar disorder
  • Glaucoma
  • Seizure disorders, including epilepsy
  • Kidney disease
  • Liver disease
  • People who are allergic to a variety of medications

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Get Help Overcoming Substance Abuse

When a person struggles with depression, anxiety, or another mental health condition, it is important for them to get help. This help often comes in the form of prescription medications and talk therapy. Long-term therapy is the best treatment to manage mood disorders, but in the short-term, prescription medications like paroxetine can stabilize mood. Many people take antidepressants off and on for several years for a variety of conditions.

Receiving treatment for mental health problems helps to prevent substance abuse. People who suffer from a mental health condition are more likely to self-medicate with alcohol, tobacco, marijuana, cocaine, or other drugs. In order to manage co-occurring disorders, professional help is key.

What to know about Paxil (paroxetine)

Paxil is available in three different oral dosage forms: an immediate release tablet, an oral suspension, and a controlled release tablet (Paxil CR).

The following table lists the different dosages and strengths in milligrams (mg) and milligrams per milliliter (mg/ml) of Paxil.

Dosage form Strength
Paxil immediate release tablets 10 mg, 20 mg, 30 mg, 40 mg
Paxil suspension 10 mg/5 ml
Paxil CR (controlled release) tablets 12.5 mg, 25 mg, 37.5 mg

The dose of Paxil that a doctor will prescribe depends on its intended use. Doctors will recommend a starting dose and may increase or decrease the dose depending on the person’s symptoms and side effects.

Major depressive disorder

People can use both the immediate release and controlled release tablets for major depressive disorder. Doctors will typically start adults on 20 mg of immediate release Paxil once daily and 10 mg once daily for older adults.

Immediate release tablets

Depending on the person’s response to Paxil, the doctor may increase the dose by 10 mg every week if needed. The maximum daily dose of Paxil for major depressive disorder in adults is 50 mg and 40 mg for older adults.

Controlled release tablets

When using controlled release tablets of Paxil, adults may begin on 25 mg once daily, and older adults will start on 12.5 mg once daily. Doctors may increase the dose by 12.5 mg every week, depending on the person’s response to treatment.

The maximum daily dose of Paxil CR in adults is 62.5 mg and 50 mg in older adults.

Generalized anxiety disorder

Doctors will recommend immediate release tablets of Paxil for treating people with generalized anxiety disorder.

The starting and continued dose is 20 mg/day, and doctors have found no evidence that higher dosages provide further benefits.

OCD

When treating people with OCD, doctors will choose immediate release tablets of Paxil.

Adults will typically start on 20 mg per day and increase this by 10 mg per day at one-week intervals. The recommended continued daily dose is 40 mg. The maximum dose is 60 mg daily.

The FDA does not approve the use of Paxil in children and adolescents, though doctors sometimes prescribe 10–50 mg of Paxil to people 7 years and older as an off label use.

Panic disorder

Share on PinterestA person can use either immediate release or controlled release tablets to help treat a panic disorder.

Adults with panic disorder can use both immediate release and controlled release tablets.

Immediate release tablets

Adults will usually take 40 mg per day for panic disorder. People typically start on 10 mg/day and increase this by 10 mg per day at intervals of at least 1 week. People should not exceed 60 mg per day.

Controlled release tablets

When choosing controlled release tablets, people can start with 12.5 mg per day and will typically reach an effective dose between 12.5 mg and 75 mg.

Social anxiety or social phobia

People aged 8 years and older can use immediate release or controlled release tablets to treat social phobias.

The following table shows the starting dose, weekly increase, and maximum daily dose for each dosage form of Paxil for children, adults, and older adults.

Starting daily dose Weekly increase Maximum daily dose
Adults Immediate release: 20 mg
Controlled release: 12.5 mg
Immediate release: 10 mg
Controlled release: 12.5 mg
Immediate release: 60 mg
Controlled release: 37.5 mg
Older adults Immediate release: 10 mg Immediate release: 10 mg Immediate release: 40 mg
Children and adolescents 8 years and older Immediate release: 10 mg Immediate release: 10 mg Immediate release : 50 mg

PTSD

Adults and older adults can use immediate release Paxil to help with the symptoms of PTSD.

Adults will typically start on 20 mg per day, with a maximum dose of 50 mg. Older adults may begin with 10 mg per day up to a maximum dose of 40 mg.

PDD

People can take Paxil to treat PDD. This is a depressive condition linked with the menstrual cycle. People will only take Paxil at certain times in their menstrual cycle, such as the luteal phase.

People can use immediate release or controlled release tablets for PDD. The effective dose is:

  • 12.5–25 mg for controlled release tablets
  • 5–30 mg for immediate release tablets

Paroxetine

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

Medically reviewed by Kaci Durbin, MD Last updated on Jan 14, 2019.

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What is paroxetine?

Paroxetine is an antidepressant that belongs to 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, including major depressive disorder.

Paroxetine is also used to treat panic disorder, obsessive-compulsive disorder (OCD), 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.

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 an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

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, or a stroke;

  • liver or kidney disease;

  • a bleeding or blood clotting disorder;

  • seizures or epilepsy;

  • bipolar disorder (manic depression), drug addiction, or suicidal thoughts;

  • narrow-angle glaucoma; or

  • low levels of sodium in your blood.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with paroxetine and cause a serious condition called serotonin syndrome.

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 an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking this medicine without your doctor’s advice.

Do not use Brisdelle if you are pregnant.

You should not breastfeed 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 and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

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

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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?

Avoid driving or hazardous activity until you know how paroxetine will affect you. Your reactions could be impaired.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as 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.

Drinking alcohol with this medicine can cause side effects.

Paroxetine side effects

Get emergency medical help if you have signs of an allergic reaction to paroxetine (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

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;

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

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

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common paroxetine side effects may include:

  • vision changes;

  • weakness, drowsiness, dizziness, tiredness;

  • sweating, anxiety, shaking;

  • sleep problems (insomnia);

  • loss of appetite, nausea, vomiting, diarrhea, constipation;

  • dry mouth, yawning;

  • infection;

  • headache; or

  • decreased sex drive, impotence, abnormal ejaculation, 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.

What other drugs will affect paroxetine?

Using paroxetine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

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

  • a diuretic or “water pill”;

  • 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.

Further information

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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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  • Paroxetine Controlled-Release Tablets
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  • Paroxetine (Advanced Reading)

Other brands: Paxil, Paxil CR, Brisdelle, Pexeva

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Consumer medicine information

BEFORE YOU TAKE PAROXETINE SANDOZ

Antidepressants can increase suicidal thoughts and actions in some children and adolescents younger than 18 years of age. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.

Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and adolescents, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it with your doctor. You should discuss all treatment choices with your doctor, not just the use of antidepressants.

Patients (and caregivers of patients) need to monitor for any worsening of their condition and/or the emergence of thoughts of suicide or suicidal behaviour or thoughts of harming themselves and to seek medical advice immediately if these symptoms present. (See Use In Children and Adolescents).

When you must not take it

Do not take this medicine if you have an allergy to:

  • the active ingredient paroxetine hydrochloride or to any of the other ingredients listed at the end of this leaflet under Product Description
  • any other similar medicines.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not take this medicine if you are pregnant or intend to become pregnant. Studies show that use of paroxetine in early pregnancy (first 13 weeks) may be associated with an increased risk of some birth defects in babies. If you become pregnant or intend to become pregnant while taking paroxetine, you should make an appointment to see your doctor and have your treatment reviewed. It is important that you do not stop taking paroxetine suddenly. Paroxetine is a medicine that can have withdrawal side effects if stopped suddenly

(see Unwanted events that may occur on stopping treatment).

Do not take this medicine if:

  • You are taking any other medication for the treatment of depression or have done so in the last two weeks.
    You must not take Paroxetine Sandoz until two weeks after stopping monoamine oxidase inhibitor drugs (MAOIs). Examples of MAOIs are phenelzine and tranylcypromine. Another MAOI includes the antibiotic linezolid. There may be others so please check with your doctor. Taking Paroxetine Sandoz with a MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.
  • You are taking or have recently taken (within the last two weeks) a medicine called methylthioninium chloride (methylene blue).
  • You are taking pimozide or thioridazine (medicines used to treat certain mental and emotional conditions).
  • You have taken Paroxetine Sandoz before and became unwell.
    Tell your doctor or pharmacist before taking the first dose.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Take special care with Paroxetine Sandoz if you are over 65 years of age as Paroxetine Sandoz may cause a reduction in the amount of sodium within your blood which can lead to sleepiness and muscle weakness. If you experience these symptoms, please consult your doctor as soon as possible.

Medicines like Paroxetine Sandoz may affect your sperm. Fertility in some men may be reduced while taking Paroxetine Sandoz.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to:

  • any other medicines, especially if they are in the same drug class as paroxetine (selective serotonin reuptake inhibitors)
  • any other substances, including foods, preservatives or dyes.

Tell your doctor if you are breastfeeding or intend to breastfeed. Your doctor will discuss with you the possible risks and benefits of using Paroxetine Sandoz during breastfeeding.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • epilepsy (fits)
  • heart problems
  • kidney problems
  • liver problems
  • raised pressure in the eye
  • problems with blood clotting
  • other psychiatric conditions (mania, bipolar disorder).
  • diabetes.

If you have not told your doctor about any of the above, tell him/her before you start taking Paroxetine Sandoz.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. Some combinations of medicines may increase the risk of serious side effects and are potentially life-threatening.

Some medicines and Paroxetine Sandoz may interfere with each other. These include:

  • medicines used to treat depression, anxiety, mood swings or schizophrenia, including medicines you buy without a doctor’s prescription. Examples of these medicines include pimozide, thioridazine, tryptophan and St John’s Wort, perphenazine, risperidone, lithium or atomoxetine.
  • medicines used in anaesthesia or to treat chronic pain, specifically fentanyl and tramadol.
  • medicines used to lower blood pressure or treat heart conditions such as metoprolol or flecainide
  • phenytoin, carbamazepine, phenobarbital and other medicines used to control epilepsy (anti-convulsants)
  • warfarin and other medicines used to thin blood (anti-coagulants), aspirin and non-steroidal anti-inflammatory drugs (NSAIDs)
  • selegiline, procyclidine and other medicines used to treat Parkinson’s disease
  • cimetidine and other medicines used to treat stomach ulcers
  • medicines used to treat migraine, such as sumatriptan
  • tamoxifen and other medicines used to treat breast cancer
  • fosamprenavir and/or ritonavir, medicines used to treat HIV infection
  • used in anaesthesia, such as mivacurium and suxamethonium.

These medicines may be affected by Paroxetine Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor or pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

Apo-Paroxetine

How does this medication work? What will it do for me?

Paroxetine belongs to the class of medications called selective serotonin reuptake inhibitors (SSRIs). It is used to treat depression, obsessive-compulsive disorder, panic disorder, social phobia (social anxiety disorder), generalized anxiety disorder, and post-traumatic stress disorder. It works by affecting the balance of chemicals in the brain that are associated with depression and anxiety disorders.

It may take several weeks before the full beneficial effects of this medication are felt. Continue taking the medication until you have consulted with your doctor, even if you feel your symptoms are not improving.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

10 mg
Each bright yellow, oval, biconvex, film-coated tablet, engraved “APO” on one side and “10” on the other, contains paroxetine HCl equivalent to 10 mg of paroxetine. Nonmedicinal ingredients: anhydrous lactose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol 8000, sodium starch glycolate, titanium dioxide, D&C Yellow No. 10, and FD&C Yellow No. 6.

20 mg
Each pink, oval, biconvex, scored, film-coated tablet, engraved “APO” on one side and scored and engraved “20” on the other, contains paroxetine HCl equivalent to 20 mg of paroxetine. Nonmedicinal ingredients: anhydrous lactose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol 8000, sodium starch glycolate, titanium dioxide, and D&C Red No. 30.

30 mg
Each blue, oval, biconvex, film-coated tablet, engraved “APO” on one side and “30” on the other, contains paroxetine HCl equivalent to 30 mg of paroxetine.Nonmedicinal ingredients: anhydrous lactose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol 8000, sodium starch glycolate, titanium dioxide, and FD&C Blue No. 2.

How should I use this medication?

For adults being treated for depression, the recommended starting dose is 20 mg taken once daily. This is also the dose that most people find effective. If necessary, your doctor may suggest you increase the dose slowly to a maximum of 50 mg daily.

For people being treated for obsessive-compulsive disorder, the usual starting dose of paroxetine is 20 mg taken once daily. Gradually, your doctor will have you increase the dose to the recommended dose of 40 mg daily. If necessary, the dose may be increased to a maximum of 60 mg daily.

For people being treated for panic disorder, the usual starting dose is 10 mg once daily. It should then be slowly increased to the recommended dose of 40 mg daily. If necessary, the dose may be increased to a maximum of 60 mg daily.

For social phobia (social anxiety disorder), generalized anxiety disorder and post traumatic stress disorder, the starting dose is 20 mg taken once daily. The maximum dose for treating any of these conditions is 50 mg daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones given here, do not change the way that you are taking the medication without consulting your doctor.

In all cases, this medication is usually taken first thing in the morning. It may be taken with or without food. Swallow the tablet whole – do not chew or crush it.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take paroxetine if you:

  • are allergic to paroxetine or any ingredients of the medication
  • are taking an MAO inhibitor (e.g., phenelzine, tranylcypromine, moclobemide) or have taken a MAO inhibitor within the past 2 weeks (do not start treatment with an MAO inhibitor until at least 2 weeks after stopping paroxetine treatment)
  • take the medication pimozide
  • take the medication thioridazine

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • decreased appetite
  • decreased sexual desire or ability
  • diarrhea
  • dizziness
  • drowsiness
  • dry mouth
  • headache
  • increased sweating
  • increased sensitivity to sun
  • menstrual period changes
  • nausea
  • nervousness
  • nightmares
  • tremor
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
  • weight gain

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • agitation
  • blurred vision
  • feeling restless
  • hallucinations (seeing or hearing things that aren’t there)
  • increased cholesterol levels
  • low blood pressure (dizziness or fainting when rising from a sitting or lying position)
  • new or worsening signs of depression (such as feeling sad, losing interest in things you used to enjoy, weight changes, changes in sleep habits, feelings of guilt or worthlessness, thoughts of suicide)
  • problems with urination
  • restless legs syndrome (irresistible urge to move the legs)
  • signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • skin rash
  • symptoms of glaucoma (e.g., eye pain, blurred vision)
  • symptoms of low blood sodium (confusion, seizures, drowsiness, dryness of mouth, increased thirst, lack of energy)
  • talking, feeling, and acting with excitement and activity you cannot control
  • uncontrollable movements of the body or face

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizure or convulsions
  • serotonin syndrome (signs include agitation, confusion, diarrhea, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, twitching)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • thoughts of suicide or hurting yourself

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal bleeding: Paroxetine, like other similar medications, may cause abnormal bleeding, including bleeding in the stomach or intestines. People who have or have had a history of bleeding disorders should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report any unusual bruising or bleeding to your doctor, especially if you are taking other medications that affect blood clotting. These medications include acetylsalicylic acid (ASA), clopidogrel, dipyridamole, nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen or naproxen), other anticoagulant medications (e.g., warfarin), and certain antipsychotic medications.

Bone fracture: This medication may increase the risk of bone fractures (breaks) when taking this medication. If you have osteoporosis or any other illness that increases your risk for breaking bones, or are at risk for developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: Although paroxetine is not known to cause drowsiness, it is advisable to avoid driving or operating hazardous machinery until you determine how paroxetine affects your ability to do these things safely.

Glaucoma: Paroxetine can cause an increase in the pressure in the eye, making symptoms of glaucoma worse. If you have narrow-angle glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease: If you have heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: People with kidney disease may need lower doses of this medication. If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Mania: Paroxetine may cause symptoms of mania to worsen or return. If you have a history of mania or bipolar disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: There have been occasional reports of seizures occurring with paroxetine. If you have a history of seizures discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Anyone who develops seizures should seek immediate medical attention.

Serotonin syndrome: Severe reactions are possible when paroxetine is combined with other medications that act on serotonin, such as tricyclic antidepressants, “triptan” medications for migraine and some medications to treat nausea due to chemotherapy. These combinations should be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

If you are taking other medications that affect serotonin, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stopping the medication: Stopping this medication suddenly may lead to side effects such as dizziness, abnormal dreams, numbness or tingling sensations, agitation, anxiety, nausea, vomiting, sweating, or other symptoms. If you are thinking of stopping the medication, check with your doctor first. Your doctor may want you to decrease the dose of the medication gradually when it is time to stop taking paroxetine.

Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These behavioural changes may be more likely to occur in children and adolescents, however they are possible for all age groups that use this medication. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Paroxetine has been reported to cause an increase in birth defects, primarily of the heart, in babies born to women who have taken it in the first trimester. It has also been reported that babies born to women who took medications of this kind during the last trimester of their pregnancy may experience adverse effects (such as breathing problems, seizures, trouble feeding, vomiting, low blood sugar, shaking, jitteriness, irritability, and constant crying) that result in an increase in the length of hospital stay. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking paroxetine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and effectiveness of paroxetine for those less than 18 years of age have not been established. The use of this medication by children and adolescents less than 18 years old may cause behavioural and emotional changes, such as suicidal thoughts and behaviour.

Seniors: Seniors may need lower doses of this medication, and they should be closely monitored by their doctor when taking paroxetine.

What other drugs could interact with this medication?

There may be an interaction between paroxetine and any of the following:

  • abiraterone
  • acetylsalicylic acid (ASA)
  • alcohol
  • alfuzosin
  • alteplase
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine, methamphetamine)
  • antihistamines (e.g., diphenhydramine, hydroxyzine)
  • antipsychotic medications (e.g., chlorpromazine, haloperidol, olanzapine, quetiapine, risperidone)
  • apixaban
  • atomoxetine
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • beta-blockers (e.g., carvedilol, metoprolol, propranolol)
  • bromocriptine
  • bupropion
  • buspirone
  • cabergoline
  • captopril
  • celecoxib
  • certain antiarrhythmic medications (e.g., disopyramide, flecainide, propafenone)
  • chloral hydrate
  • chloroquine
  • cimetidine
  • cinacalcet
  • clopidogrel
  • cobicistat
  • cyclophosphamide
  • dabigatran
  • darifenacin
  • dasatinib
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • desmopressin
  • dextromethorphan
  • dipyridamole
  • dofetilide
  • domperidone
  • doxorubicin
  • dronedarone
  • efavirenz
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • galantamine
  • general anesthetics (medications used to put people to sleep before surgery)
  • glucosamine
  • heparin
  • herbal products that affect blood clotting (e.g., cat’s claw, chamomile, fenugreek, evening primrose, feverfew, garlic, ginger, ginseng, turmeric)
  • ifosfamide
  • irinotecan
  • ketoconazole
  • levothyroxine
  • linezolid
  • lithium
  • losartan
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • MAO inhibitors (e.g., linezolid, moclobemide, phenelzine, selegiline, tranylcypromine)
  • methadone
  • methylene blue
  • metoclopramide
  • metyrosine
  • mexiletine
  • mifepristone
  • mirabegron
  • mirtazapine
  • multivitamins/minerals
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine, tizanidine)
  • narcotic pain relievers (e.g., codeine, fentanyl, methadone, morphine, oxycodone)
  • nefazodone
  • nilotinib
  • nonsteroidal anti-inflammatory medications (NSAIDs; diclofenac, ibuprofen, naproxen)
  • omega-3 fatty acids
  • olopatadine
  • peginterferon Alfa-2b
  • pentoxifylline
  • pimozide
  • pravastatin
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., levofloxacin, moxifloxacin)
  • rasagiline
  • ritonavir
  • rivaroxaban
  • scopolamine
  • seizure medications (e.g., carbamazepine, clobazam, felbamate, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • serotonin/norepinephrine reuptake inhibitors (SNRIs e.g., desvenlafaxine, duloxetine, venlafaxine)
  • other selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, sertraline)
  • 5-HT3 antagonists (e.g., granisetron, ondansetron)
  • St. John’s wort
  • tamoxifen
  • tamsulosin
  • tapentadol
  • terbinafine
  • tetrabenazine
  • thiazide diuretics (e.g., hydrochlorothiazide, indapamide)
  • ticagrelor
  • ticlopidine
  • tolterodine
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., nortriptyline, amitriptyline, imipramine, desipramine)
  • “triptan” migraine medications (e.g., sumatriptan, zolmitriptan, rizatriptan)
  • tryptophan
  • tyrosine kinase inhbitors (e.g., imatinib, lapatinib, pazopanib, sunitinib)
  • vitamin E
  • warfarin
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Apo-Paroxetine

Paroxetine, Oral Tablet

This dosage information is for paroxetine oral tablet. All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

Forms and strengths

Generic: Paroxetine

  • Form: Immediate-release oral tablet
  • Strengths: 10 mg, 20 mg, 30 mg, 40 mg
  • Form: Extended-release oral tablet
  • Strengths: 12.5 mg, 25 mg, 37.5 mg

Brand: Paxil

  • Form: Immediate-release oral tablet
  • Strengths: 10 mg, 20 mg, 30 mg, 40 mg

Brand: Paxil CR

  • Form: Extended-release oral tablet
  • Strengths: 12.5 mg, 25 mg, 37.5 mg

Brand: Pexeva

  • Form: Immediate-release oral tablet
  • Strengths: 10 mg, 20 mg, 30 mg, 40 mg

Dosage for major depressive disorder

Adult dosage (ages 18–64 years)

You should take this drug in one dose per day. You should be on the lowest dose that works for you.

  • Immediate-release oral tablets (Paxil, Pexeva):
    • The typical starting dose is 20 mg per day.
    • If a 20-mg dose is not enough, your doctor will start increasing your dose each week by 10 mg per day.
    • Your maximum daily dose shouldn’t exceed 50 mg per day.
  • Extended-release oral tablets (Paxil CR):
    • The initial dose is 25 mg per day.
    • If you don’t respond to a 25-mg dose, your doctor will increase your dose each week by 12.5 mg per day.
    • The maximum dose is 62.5 mg per day.
  • Oral extended-release tablets (Paxil CR):
    • The initial dose is 25 mg per day.
    • If you don’t respond to a 25-mg dose, your doctor will increase your dose each week by 12.5 mg per day.
    • The maximum dose is 62.5 mg per day.
  • Child dosage (ages 0–17 years)

    It hasn’t been confirmed that this drug is safe and effective for use in people younger than 18 years.

    Senior dosage (ages 65 years and older)

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.
    • Extended-release oral tablets (Paxil CR):
      • The recommended starting dose is 12.5 mg per day.
      • The maximum dose is 50 mg per day.

    Special dosage considerations

    For severe kidney disease

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.
    • Extended-release oral tablets (Paxil CR):
      • The recommended starting dose is 12.5 mg per day.
      • The maximum dose is 50 mg per day.

    For severe liver disease

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.
    • Extended-release oral tablets (Paxil CR):
      • The recommended starting dosage is 12.5 mg per day.
      • The maximum dosage is 50 mg per day.

    Dosage for obsessive-compulsive disorder

    Adult dosage (ages 18–64 years)

    You should take this drug in one dose per day. You should be on the lowest dose that works for you.

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The typical starting dose is 20 mg per day.
      • The target dose is 40 mg day. Your doctor will increase your dose each week by 10 mg per day to get to the target dose.
      • The maximum dose is 60 mg per day.

    Child dosage (ages 0–17 years)

    It hasn’t been confirmed that this drug is safe and effective for use in people younger than 18 years.

    Senior dosage (ages 65 years and older)

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.

    Special dosage considerations

    For severe kidney disease

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.

    For severe liver disease

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.

    Dosage for panic disorder

    Adult dosage (ages 18–64 years)

    You should take this drug in one dose per day. You should be on the lowest dose that works for you.

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The typical starting dose is 10 mg per day.
      • The target dose is 40 mg per day. Your doctor will increase your dose each week by 10 mg per day to get to the target dose.
      • The maximum dose is 60 mg per day.
    • Extended-release oral tablets (Paxil CR):
      • The initial dose is 12.5 mg per day.
      • If you don’t respond to a 12.5-mg dose, your doctor will increase your dose each week by 12.5 mg per day.
      • The maximum dose is 75 mg per day.

    Child dosage (ages 0–17 years)

    It hasn’t been confirmed that this drug is safe and effective for use in people younger than 18 years.

    Senior dosage (ages 65 years and older)

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg once per day.
      • The maximum dose is 40 mg per day.
    • Extended-release oral tablets (Paxil CR):
      • The recommended starting dose is 12.5 mg per day.
      • The maximum dose is 50 mg per day.

    Special dosage considerations

    For severe kidney disease

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.
    • Extended-release oral tablets (Paxil CR):
      • The recommended starting dose is 12.5 mg per day.
      • The maximum dose is 50 mg per day.

    For severe liver disease

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.
    • Extended-release oral tablets (Paxil CR):
      • The recommended starting dosage is 12.5 mg per day.
      • The maximum dosage is 50 mg per day.

    Dosage for social anxiety disorder

    Adult dosage (ages 18–64 years)

    You should take this drug in one dose per day. You should be on the lowest dose that works for you.

    • Immediate-release oral tablets (Paxil):
      • The typical starting dose is 20 mg per day.
      • If a 20-mg dose is not enough, your doctor will start increasing your dose each week by 10 mg per day.
      • The recommended dose to treat social anxiety disorder is 20–60 mg per day.
    • Extended-release oral tablets (Paxil CR):
      • The initial dose is 12.5 mg per day.
      • If you don’t respond to a 12.5-mg dose, your doctor will increase your dose each week by 12.5 mg per day.
      • The maximum dose is 37.5 mg per day.

    Child dosage (ages 0–17 years)

    It hasn’t been confirmed that this drug is safe and effective for use in people younger than 18 years.

    Senior dosage (ages 65 years and older)

    • Immediate-release oral tablets (Paxil):
      • The recommended starting dose is 10 mg once per day.
      • The maximum dose is 40 mg per day.
    • Extended-release oral tablets (Paxil CR):
      • The recommended starting dose is 12.5 mg per day.
      • The maximum dose is 50 mg per day.

    Special dosage considerations

    For severe kidney disease

    • Immediate-release oral tablets (Paxil):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.
    • Extended-release oral tablets (Paxil CR):
      • The recommended starting dose is 12.5 mg per day.
      • The maximum dose is 50 mg per day.

    For severe liver disease

    • Immediate-release oral tablets (Paxil):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.
    • Extended-release oral tablets (Paxil CR):
      • The recommended starting dose is 12.5 mg per day.

    Dosage for generalized anxiety disorder

    Adult dosage (ages 18–64 years)

    You should take this drug in one dose per day. You should be on the lowest dose that works for you.

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The typical starting dose is 20 mg per day.
      • If a 20-mg dose is not enough, your doctor will start increasing your dose each week by 10 mg per day.
      • The recommended dose to treat generalized anxiety disorder is 20–50 mg per day.

    Child dosage (ages 0–17 years)

    It hasn’t been confirmed that this drug is safe and effective for use in people younger than 18 years.

    Senior dosage (ages 65 years and older)

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg once per day.
      • The maximum dose is 40 mg per day.

    Special dosage considerations

    For severe kidney disease

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.

    For severe liver disease

    • Immediate-release oral tablets (Paxil, Pexeva):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.

    Dosage for post-traumatic stress disorder

    Adult dosage (ages 18–64 years)

    You should take this drug in one dose per day. You should be on the lowest dose that works for you.

    • Immediate-release oral tablets (Paxil):
      • The typical starting dose is 20 mg per day.
      • If a 20-mg dose is not enough, your doctor will start increasing your dose each week by 10 mg per day.
      • The recommended dose to treat posttraumatic stress disorder is 20–50 mg per day.

    Child dosage (ages 0–17 years)

    It hasn’t been confirmed that this drug is safe and effective for use in people younger than 18 years.

    Senior dosage (ages 65 years and older)

    • Immediate-release oral tablets (Paxil):
      • The recommended starting dose is 10 mg once per day.
      • The maximum dose is 40 mg per day.

    Special dosage considerations

    For severe kidney disease

    • Immediate-release oral tablets (Paxil):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.

    For severe liver disease

    • Immediate-release oral tablets (Paxil):
      • The recommended starting dose is 10 mg per day.
      • The maximum dose is 40 mg per day.

    Dosage for premenstrual dysphoric disorder

    Adult dosage (ages 18–64 years)

    You should take this drug in one dose per day. You should be on the lowest dose that works for you.

    • Extended-release oral (Paxil CR):
      • The typical starting dose is 12.5 mg per day, usually taken in the morning.
      • Depending on your symptoms, your dose can be increased up to 25 mg per day.
      • Dose changes should occur at intervals of at least one week.

    Child dosage (ages 0–17 years)

    It hasn’t been confirmed that this drug is safe and effective for use in people younger than 18 years.

    Senior dosage (ages 65 years and older)

    • Extended-release oral (Paxil CR):
      • The recommended starting dose is 12.5 mg once per day
      • The maximum dose is 50 mg per day.

    Special dosage considerations

    For severe kidney disease

    • Extended-release oral (Paxil CR):
      • The recommended starting dose is 12.5 mg per day.
      • The maximum dose is 50 mg per day.

    For severe liver disease

    • Extended-release oral (Paxil CR):
      • The recommended starting dose is 12.5 mg per day.
      • The maximum dose is 50 mg per day.

    Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

    SIDE EFFECTS

    The following adverse reactions are included in more detail in other sections of the prescribing information:

    • Hypersensitivity reactions to paroxetine
    • Suicidal Thoughts and Behaviors
    • Serotonin Syndrome
    • Embryofetal and Neonatal Toxicity
    • Increased Risk of Bleeding
    • Activation of Mania/Hypomania
    • Discontinuation Syndrome
    • Seizures
    • Angle-closure Glaucoma
    • Hyponatremia
    • Bone Fracture

    Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    Safety data for PAXIL CR is from 11 short-term, placebo-controlled clinical trials including 3 studies in patients with major depressive disorder (MDD) (Studies 1, 2, and 3), 3 studies in patients with panic disorder (PD) (Studies 4, 5, and 6), 1 study in patients with social anxiety disorder (SAD) (Study 7), and 4 studies in female patients with premenstrual dysphoric disorder (PMDD) (Studies 8, 9, 10, and 11) . These 11 trials included 1627 patients treated with Paxil CR.

    • Studies 1 and 2 were 12-week studies that enrolled patients 18 to 65 years old who received PAXIL CR at doses ranging from 25 mg to 62.5 mg once daily. Study 3 was a 12-week study in patients 60 to 88 years old who received PAXIL CR at doses ranging from 12.5 mg to 50 mg once daily.
    • Studies 4, 5, and 6 were 10-week studies in patients 19 to 72 years old who received PAXIL CR at doses ranging from 12.5 mg to 75 mg once daily.
    • Study 7 was a 12-week study that enrolled adult patients who received PAXIL CR at doses ranging from 12.5 mg to 37.5 mg once daily.
    • Studies 8, 9, and 10 were 12-week, placebo-controlled trials in female patients 18 to 46 years old who received PAXIL CR at doses of 12.5 mg or 25 mg once daily. Study 11 was a 12-week placebo-controlled trial in patients 18 to 46 years old who received PAXIL CR 2 weeks prior to the onset of menses (luteal phase dosing) at doses of 12.5 mg or 25 mg once daily.

    Adverse Reactions Leading To Discontinuation In Patients With MDD, PD, SAD, And PMDD

    In pooled studies in patients with MDD, PD and SAD, the most common adverse reactions leading to study withdrawal were: nausea (up to 4% of patients), asthenia, headache, depression, insomnia, and abnormal liver function tests (each occurring in up to 2% of patients), and dizziness, somnolence, and diarrhea (each occurring in up to 1% of patients).

    In pooled studies for PMDD, the most common adverse reactions leading to study withdrawal were: nausea (occurring in up to 6% of patients), asthenia (occurring in up to 5% of patients), somnolence (occurring in up to 4% of patients), insomnia (occurring in approximately 2% of patients); and impaired concentration, dry mouth, dizziness, decreased appetite, sweating, tremor, yawn and diarrhea (occurring in less than or equal to 2% of patients).

    Adverse Reactions In MDD, PD, And SAD

    Table 3 presents the most common adverse reactions in PAXIL CR-treated patients (incidence ≥5% and greater than placebo within at least 1 of the indications) in controlled trials in patients with MDD, PD, and SAD.

    Table 3: Adverse Reactions (≥5% of Patients Treated with PAXIL CR and Greater than Placebo) in 10 to 12 Week Studies of MDD, PD, and SAD

    Body System/ Adverse Reaction MDD18 to 65 year olds MDD≥60 years old Panic Disorder Social Anxiety Disorder
    PAXIL CR
    (N=212) %
    Placebo
    (N=211) %
    PAXIL CR
    (N=104) %
    Placebo
    (N=109 %
    PAXIL CR
    (N=444) %
    Placebo
    (N=445) %
    PAXIL CR
    (N=186) %
    Placebo
    (N=184) %
    Body as a Whole
    Headache 27 20 17 13 NA NA 23 17
    Asthenia 14 9 15 14 15 10 18 7
    Abdominal Pain 7 4 6 4 5 4
    Back Pain 5 3 NA NA 4 1
    Digestive System
    Nausea 22 10 23 17 22 6
    Diarrhea 18 7 15 9 12 9 9 8
    Dry Mouth 15 8 18 7 13 9 3 2
    Constipation 10 4 13 5 9 6 5 2
    Flatulence 6 4 NA NA NA NA
    Decreased Appetite 2 12 5 8 6 1 <1
    Dyspepsia NA NA 13 10 NA NA 2 <1
    Musculoskel etal System
    Myalgia NA NA 5 3 NA NA
    Nervous System
    Somnolence 22 8 21 12 20 9 9 4
    Insomnia 17 9 10 8 20 11 9 4
    Dizziness 14 4 9 5 NA NA 7 4
    Libido Decreased 7 3 8 <1 9 4 1
    Nervousness NA NA 8 7 NA NA
    Tremor 7 1 7 0 8 2 4 2
    Anxiety NA NA 5 4 2 1
    Respiratory System
    Sinusitis NA NA 8 5 NA NA
    Yawn 0 3 0 2 0
    Skin and Appendages
    Sweating 6 2 10 <1 7 2 14 3
    Special Senses
    Abnormal Visiona 5 1 3 <1 2 0
    Urogenital System
    Abnormal Ejaculationb,c 26 1 17 3 27 3 15 1
    Female Genital Disorderb,d 10 <1 7 1 3 0
    Impotenceb 5 3 9 3 10 1 9 0
    Hyphen = the reaction listed occurred in <5% of patients treated with PAXIL CR
    NA = the adverse reaction listed did not occur in this group of patients
    a Mostly blurred vision
    b Based on the number of males or females
    c Mostly anorgasmia or delayed ejaculation
    d Mostly anorgasmia or delayed orgasm

    Other Adverse Reactions Observed During The Premarketing Evaluation Of PAXIL CR

    Adverse reactions from studies in MDD (not including Study 3 in elderly patients), PD, and SAD that occurred between 1% and 5% of patients treated with PAXIL CR and at a rate greater than in placebo-treated patients include:, allergic reaction, tachycardia, vasodilatation, hypertension, migraine, vomiting, weight loss, weight gain, hypertonia, paresthesia, agitation, confusion, myoclonus, concentration impaired, depression, rhinitis, cough increased, bronchitis, photosensitivity, eczema, taste perversion, UTI, menstrual disorder, urinary frequency, urination impaired, and vaginitis.

    Adverse Reactions In Patients With PMDD

    Table 4 displays adverse reactions that occurred (incidence of 5% or more and greater than placebo within at least 1 of the studies) in patients treated with PAXIL CR in Studies 8, 9, 10, and 11.

    Table 4: Adverse Reactions (≥5% of Patients Treated with PAXIL CR and Greater than Placebo) in Pooled Studies PMDD (Studies 8, 9, 11), and in Study 10a,b,c

    Body 40%
    System/Adverse Reaction
    % Reporting At verse Reaction
    Continuous Dosing Studies 8, 9, and 10 Luteal Phase Dosing Study 11
    PAXIL CR
    (n = 681) %
    Placebo
    (n = 349) %
    PAXIL CR
    (n = 246) %
    Placebo
    (n = 120) %
    Body as a Whole
    Asthenia 17 6 15 4
    Headache 15 12 NA NA
    Infection 6 4 NA NA
    Digestive System
    Nausea 17 7 18 2
    Diarrhea 6 2 6 0
    Constipation 5 1 2 <1
    Nervous System
    Libido Decreased 12 5 9 6
    Somnolence 9 2 3 <1
    Insomnia 8 2 7 3
    Dizziness 7 3 6 3
    Tremor 4 <1 5 0
    Skin and Appendages
    Sweating 7 <1 6 <1
    Urogenital System
    Female Genital Disordersc 8 1 2 0
    NA= the adverse reaction information is not available in this population.
    a <1% means greater than zero and less than 1%.
    b The luteal phase and continuous dosing PMDD trials were not designed for making direct comparisons between the 2 dosing regimens.
    c Mostly anorgasmia or difficulty achieving orgasm.

    Dose Dependent Adverse Reactions

    Comparison of the incidence of adverse reactions (placebo vs. 12.5 mg PAXIL CR vs. 25 mg PAXIL CR) from studies 8, 9, 10 showed the following adverse reactions to be dose-related: Nausea, somnolence, sweating, dry mouth, dizziness, decreased appetite, tremor, impaired concentration, yawn, paresthesia, hyperkinesia, and vaginitis.

    Male And Female Sexual Dysfunction

    Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.

    The percentage of patients reporting symptoms of sexual dysfunction in the Studies 1 and 2 (nonelderly patients with MDD), 4, 5, 6, 7, 8, 9, 10, and 11 are presented in Table 5:

    Table 5: Adverse Reactions Related To Sexual Dysfunction In Patients Treated With PAXIL CR in Pooled 10-12 Week Studies of MDD, PD, SAD, and PMDD

    Studies 1 and 2 % Studies 4, 5, and 6 % Study 7 % Studies 8, 9, and 11 (Continuous Dosing) % Study 10 (Luteal Phase Dosing) %
    PAXIL CR Placebo PAXIL CR Placebo PAXI L CR Placebo PAXIL CR Placebo PAXI L CR Placebo
    n (males) 78 78 162 194 88 97 NA NA NA NA
    Decreased Libido 10 5 9 6 13 1 NA NA NA NA
    Abnormal ejaculation 26 1 27 3 15 1 NA NA NA NA
    Impotence 5 3 10 1% 9 0 NA NA NA NA
    n (females) 134 133 282 251 98 87 681 349 246 120
    Decreased Libido 4 2 8 2 4 1 12 5 9 6
    Orgasmic Disturbance 10 <1 7 1 3 0 8 1 2 0
    NA = the adverse reaction listed did not occur in this group of patients.

    Paroxetine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae.

    Less Common Adverse Reactions

    The following adverse reactions occurred during the clinical studies of PAXIL CR and are not included elsewhere in the labeling.

    Reactions are categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent adverse reactions are those occurring on 1 or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare reactions are those occurring in fewer than 1/1,000 patients.

    Cardiovascular System: Infrequent was postural hypotension.

    Hemic and Lymphatic System: Rare was thrombocytopenia.

    Metabolic and Nutritional Disorders: Infrequent were generalized edema and hypercholesteremia.

    Nervous System: Infrequent were convulsion, akathisia, and manic reaction.

    Psychiatric: Infrequent were hallucinations.

    Skin and Appendages: Frequent was rash; infrequent was urticaria; rare was angioedema and erythema multiforme.

    Urogenital System: Infrequent was urinary retention; rare was urinary incontinence.

    Postmarketing Experience

    The following reactions have been identified during post approval use of paroxetine. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barré syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, priapism, syndrome of inappropriate ADH secretion (SIADH), prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, dystonia, hypertonia, trismus; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), and vasculitic syndromes (such as Henoch-Schönlein purpura).

    Read the entire FDA prescribing information for Paxil (Paroxetine Hydrochloride)

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