Pexeva

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

What is Pexeva (paroxetine)?

Paroxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paroxetine affects chemicals in the brain that may become unbalanced.

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.

What is the most important information I should know about Pexeva (paroxetine)?

You should not use paroxetine if you are also taking pimozide or thioridazine, or if you are being treated with methylene blue injection. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

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

Slideshow: Flashback: FDA Drug Approvals 2013

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

Do not give paroxetine to anyone younger than 18 years old without the advice of a doctor. Paroxetine is not approved for use in children.

What should I discuss with my healthcare provider before taking Pexeva (paroxetine)?

You should not use this medicine if you are allergic to paroxetine, or if:

  • you are also taking pimozide or thioridazine; or

  • you are being treated with methylene blue injection.

Do not use an MAO inhibitor within 14 days before or 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:

  • 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

  • if you take warfarin (Coumadin) to prevent blood clots.

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

FDA pregnancy category D. Taking an SSRI antidepressant during pregnancy may cause heart defects, serious lung problems, or other complications in the baby. However, you may have withdrawal symptoms or a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant while taking paroxetine. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

Paroxetine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Do not give paroxetine to anyone younger than 18 years old without the advice of a doctor. Paroxetine is not approved for treating depression in children.

How should I take Pexeva (paroxetine)?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid 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 at room temperature away from moisture, heat, and light.

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 Pexeva (paroxetine)?

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.

Drinking alcohol can increase some of the side effects of paroxetine.

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

Pexeva (paroxetine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty 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:

  • unusual bone pain or tenderness, swelling or bruising;

  • 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 side effects may include:

  • mild headache, drowsiness, dizziness, tired feeling;

  • sleep problems (insomnia), feeling restless or nervous;

  • mild nausea, constipation, weight changes;

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

  • dry mouth, yawning, or ringing in your ears.

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.

See also: Side effects (in more detail)

What other drugs will affect Pexeva (paroxetine)?

Taking paroxetine with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking paroxetine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with paroxetine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with paroxetine, especially:

  • any other antidepressant;

  • tamoxifen;

  • tramadol;

  • tryptophan (sometimes called L-tryptophan); or

  • medicine to treat mental illness--lithium, thioridazine, and others.

This list is not complete and many other drugs can interact with paroxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

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 this medication 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 1996-2012 Cerner Multum, Inc. Version: 24.01. Revision Date: 2013-09-06, 12:44:26 PM.

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