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

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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.

Paroxetine may cause heart defects or serious, life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking paroxetine, do not stop taking the medication without first talking to your doctor.

Do not take paroxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

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 become unbalanced.

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

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

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

Do not use paroxetine if you are using pimozide (Orap), thioridazine (Mellaril), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam).

Serious and sometimes fatal reactions can occur when these medicines are taken with paroxetine. You must wait at least 14 days after stopping an MAO inhibitor before you can take paroxetine. After you stop taking paroxetine, you must wait at least 14 days before you start taking an MAOI.

Before taking paroxetine, tell your doctor if you are allergic to any drugs, or if you have:

• liver or kidney disease;
• a bleeding or blood clotting disorder;
• seizures or epilepsy; or
• bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category D. Paroxetine may cause heart defects or serious, life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking paroxetine, do not stop taking the medication without first talking to your doctor.

Paroxetine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take paroxetine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from the medication.

Try to take the medicine at the same time each day. Follow the directions on your prescription label.

Do not crush, chew, or break a controlled-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Shake the liquid form of paroxetine well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

It may take up to 4 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.

You may have withdrawal symptoms (such as agitation, dizziness, numbness or tingling, ringing in your ears, confusion, or behavior changes) after you stop taking paroxetine. Do not stop taking this medication suddenly without first talking to your doctor.

Store paroxetine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have taken too much of this medication. Overdose symptoms may include nausea, vomiting, tremor, sweating, decreased urination, blurred vision, rapid heartbeat, confusion, aggression, seizures, and coma.

What should I avoid while taking paroxetine?

Avoid drinking alcohol, which can increase some of the side effects of paroxetine.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, or anxiety can add to sleepiness caused by paroxetine. Tell your doctor if you regularly use any of these medicines, or any other antidepressant.

Paroxetine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What are the possible side effects of paroxetine?

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.

Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/or physical hyperactivity), thoughts of suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• seizure (convulsions);
• tremors, shivering, muscle stiffness or twitching;
• problems with balance or coordination;
• agitation, confusion, sweating, fast heartbeat; or
• easy bruising or bleeding (such as a nosebleed).

Less serious side effects may include:

• feeling nervous, restless, or unable to sit still;
• drowsiness, dizziness, weakness;
• sleep problems (insomnia);
• nausea, constipation, loss of appetite;
• 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. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect paroxetine?

Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with paroxetine may cause you to bruise or bleed easily.

Many drugs can interact with paroxetine. Below is just a partial list. Tell your doctor if you are using:

• a blood thinner such as warfarin (Coumadin);
• cimetidine (Tagamet);
• fosamprenavir (Lexiva);
• linezolid (Zyvox);
• ritonavir (Norvir);
• St. John's wort;
• tamoxifen (Nolvadex, Soltamox);
• theophylline (Elixophyllin, Theo-24, Uniphyl);
• tramadol (Ultram);
• tryptophan (also called L-tryptophan);
• heart medication such as digoxin (digitalis, Lanoxin), flecainide (Tambocor), quinidine (QuinaGlute, Quinidex, Quin-Release), risperidone (Risperdal), or propafenone (Rhythmol);
• any other antidepressant such as amitriptyline (Elavil), citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), or sertraline (Zoloft);
• medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), lithium (Lithobid, Eskalith), or perphenazine (Trilafon); or
• almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig).

This list is not complete and there may be other drugs that can interact with paroxetine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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.

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 1996-2003 Cerner Multum, Inc. Version: 16.01. Revision date: 08/22/2008.