Generic Name: paroxetine (pa-ROX-a-teen)

Brand Names: Paxil®, Paxil CR®, Pexeva®

Classification: Antidepressant - Selective Serotonin Reuptake Inhibitors (SSRIs)

Issue Date: 1993

Paxil is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paxil affects chemicals in the brain that may become unbalanced. Paxil is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). Paxil is also used in the treatment of Fibromyalgia.

You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are a child or young adult. Talk with your doctor about this risk. While you are taking Paxil you will need to be monitored for worsening symptoms of depression and/or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. In addition to you watching for changes in your own symptoms, your family or other caregivers should 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.

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

Paxil 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 Paxil, do not stop taking the medication without first talking to your doctor.

Do not take Paxil together with:

• pimozide (Orap®)
• thioridazine (Mellaril®)
• isocarboxazid (Marplan®)
• phenelzine (Nardil®)
• rasagiline (Azilect®)
• selegiline (Eldepryl®, Emsam®)
• tranylcypromine (Parnate®)

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 Paxil 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
• behavior changes

after you stop taking Paxil. Do not stop taking this medication suddenly without first talking to your doctor. Store Paxil at room temperature away from moisture and heat.

You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are a child or young adult. Talk with your doctor about this risk. While you are taking Paxil you will need to be monitored for worsening symptoms of depression and/or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. In addition to you watching for changes in your own symptoms, your family or other caregivers should 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.

Do not use Paxil if you are using:

• pimozide (Orap®)
• thioridazine (Mellaril®)
• isocarboxazid (Marplan®)
• phenelzine (Nardil®)
• rasagiline (Azilect®)
• selegiline (Eldepryl®, Emsam®)
• tranylcypromine (Parnate®)

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

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

• liver or kidney disease
• seizures or epilepsy
• bipolar disorder (manic depression)
• history of drug abuse
• suicidal thoughts

If you have any of these conditions, you may not be able to use Paxil, or you may need a dosage adjustment or special tests.

Paxil 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 Paxil, do not stop taking the medication without first talking to your doctor.

Paxil 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.

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

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

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

Other less serious side effects are more likely to occur, such as:

• 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
• dry mouth
• yawning
• ringing in your ears

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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®)

Taking any of these drugs with Paxil may cause you to bruise or bleed easily.

Before taking Paxil, tell your doctor if you are using any of the following medicines:

• atomoxetine (Strattera®)
• cimetidine (Tagamet®)
• fosamprenavir (Lexiva®)
• lithium (Lithobid®, Eskalith®)
• risperidone (Risperdal®)
• ritonavir (Norvir®)
• St. John's wort
• tramadol (Ultram®)
• tryptophan (also called L-tryptophan®)
• flecainide (Tambocor®)
• propafenone (Rhythmol®)
• warfarin (Coumadin®)
• amitriptyline (Elavil®)
• citalopram (Celexa®)
• escitalopram (Lexapro®)
• fluoxetine (Prozac®, Sarafem®)
• fluvoxamine (Luvox®)
• imipramine (Tofranil®)
• nortriptyline (Pamelor®)
• sertraline (Zoloft®)
• prochlorperazine (Compazine®)
• chlorpromazine (Thorazine®)
• fluphenazine (Prolixin®)
• mesoridazine (Serentil®)
• almotriptan (Axert®)
• frovatriptan (Frova®)
• sumatriptan (Imitrex®)
• naratriptan (Amerge®)
• rizatriptan (Maxalt®)
• zolmitriptan (Zomig®)

If you are using any of these drugs, you may not be able to use Paxil, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Paxil. 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.