Brand Name(s):

• Paxil®
• Paxil®CR
• Pexeva®

IMPORTANT WARNING

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as paroxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take paroxetine, but in some cases, a doctor may decide that paroxetine is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take paroxetine or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking paroxetine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

WHY is this medicine prescribed?

Paroxetine tablets, suspension (liquid), and extended-release (long-acting) tablets are used to treat depression, panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). Paroxetine tablets and suspension are also used to treat obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), generalized anxiety disorder (GAD; excessive worrying that is difficult to control), and posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience). Paroxetine extended-release tablets are also used to treat premenstrual dysphoric disorder (PMDD, physical and psychological symptoms that occur before the onset of the menstrual period each month). Paroxetine is in a class of medications called selective serotonin-reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

HOW should this medicine be used?

Paroxetine comes as a tablet, a suspension (liquid), and a controlled-release (long-acting) tablet to take by mouth. It is usually taken once daily in the morning or evening, with or without food. You may want to take paroxetine with food to prevent stomach upset. Take paroxetine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take paroxetine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well before each use to mix the medication evenly.

Swallow the extended-release and regular tablets whole; do not chew or crush them.

Your doctor may start you on a low dose of paroxetine and gradually increase your dose, not more than once a week.

Paroxetine controls your condition but does not cure it. It may take several weeks or longer before you feel the full benefit of paroxetine. Continue to take paroxetine even if you feel well. Do not stop taking paroxetine without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking paroxetine, you may experience withdrawal symptoms such as depression; mood changes; frenzied or abnormally excited mood; irritability; anxiety; confusion; dizziness; headache; tiredness; numbness or tingling in the arms, legs, hands, or feet; unusual dreams; difficulty falling asleep or staying asleep; nausea; or sweating. Tell your doctor if you experience any of these symptoms when your dose of paroxetine is decreased.

Are there OTHER USES for this medicine?

Paroxetine is also sometimes used to treat chronic headaches, tingling in the hands and feet caused by diabetes, and certain male sexual problems. Paroxetine is also used with other medications to treat bipolar disorder (mood that changes from depressed to abnormally excited). Talk to your doctor about the possible risks of using this drug for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking paroxetine,

• tell your doctor and pharmacist if you are allergic to paroxetine , any other medications, or any of the ingredients in paroxetine tablets or liquid. Ask your pharmacist or check the Medication Guide for a list of the ingredients
• tell your doctor if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); if you have stopped taking them within the past 2 weeks; or if you are taking thioridazine or pimozide (Orap). Your doctor will probably tell you not to take paroxetine. If you stop taking paroxetine, you should wait at least 2 weeks before you start to take an MAO inhibitor.
• tell your doctor and pharmacist what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants ('mood elevators') such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), and naproxen (Aleve, Naprosyn); atomoxetine (Straterra); atazanavir (Reyataz); bromocriptine (Parlodel); bupropion (Wellbutrin); buspirone (Buspar); celecoxib (Celebrex); chlorpromazine (Thorazine); cimetidine (Tagamet); clopidogrel (Plavix); codeine (found in many cough and pain medications); dexamethasone (Decadron); dextromethorphan (found in many cough medications; in Neudexta); diazepam (Valium); dicloxacillin (Dynapen); digoxin (Lanoxin); dipyridamole (Persantine); diuretics ('water pills'); fentanyl (Actiq, Duragesic, Fentora); haloperidol (Haldol); isoniazid (INH, Nydrazid); lithium (Eskalith, Lithobid); medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), encainide (Enkaid), flecainide (Tambocor), mexiletine (Mexitil), moricizine (Ethmozine), propafenone (Rythmol), and quinidine (Quinidex; in Neudexta); medications for mental illness and nausea; medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); medications for seizures such as phenobarbital and phenytoin (Dilantin); meperidine (Demerol); methadone (Dolophine); metoclopramide (Reglan); metoprolol (Lopressor, Toprol XL); ondansetron (Zofran); other selective serotonin-reuptake inhibitors such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), and sertraline (Zoloft); procyclidine (Kemadrin); propoxyphene (Darvon); propranolol (Inderal); ranitidine (Zantac); rifampin (Rifadin, Rimactane); risperidone (Risperdal); ritonavir (Norvir); sibutramine (Meridia); tamoxifen (Nolvadex); terbinafine (Lamisil); theophylline (Theobid, Theo-Dur); ticlopidine (Ticlid); timolol (Blocadren); tramadol (Ultram); trazodone (Desyrel); and venlafaxine (Effexor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products and nutritional supplements you are taking, especially St. John's wort and tryptophan.
• tell your doctor if you use or have ever used street drugs or have overused prescription medications, if you have recently had a heart attack, and if you have or have ever had glaucoma (an eye disease); seizures; bleeding from your stomach or esophagus (tube that connects the mouth and stomach) or liver, kidney, or heart disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking paroxetine, call your doctor. Paroxetine may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking paroxetine.
• you should know that paroxetine may make you drowsy and affect your judgment and thinking. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking paroxetine.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include t: he following:

• drowsiness
• coma
• uncontrollable shaking of a part of the body
• fast, pounding, irregular, or slow heartbeat
• confusion
• nausea
• vomiting
• dizziness
• seizures
• fainting
• blurred vision
• extreme tiredness
• unusual bruising or bleeding
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• flu-like symptoms
• yellowing of the skin and eyes
• aggressive behavior
• muscle pain, stiffness, or weakness
• sudden muscle twitching or jerking that you cannot control
• dark red or brown urine
• difficulty urinating
• diarrhea
• frenzied, abnormally excited mood
• sweating
• fever
• difficulty walking

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 13, 2012.