Paroxetine (By mouth)

Introduction

Paroxetine (par-OX-e-teen)

Treats depression, obsessive-compulsive disorder (OCD), panic disorder, social anxiety disorder (also known as social phobia), premenstrual dysphoric disorder (PMDD), generalized anxiety disorder (GAD), and posttraumatic stress disorder (PTSD). This medicine is a selective serotonin reuptake inhibitor (SSRI).

Brand Name(s)

Paxil CR, Paxil, Pexeva

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to paroxetine, or if you are pregnant. Do not use this medicine if you are also currently using linezolid (Zyvox®), methylthioninium chloride (methylene blue), pimozide (Orap®), or thioridazine (Mellaril®). Do not use this medicine if you are receiving or in the previous 2 weeks have received an MAO inhibitor (such as Eldepryl®, Marplan®, Nardil®, or Parnate®).

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using cimetidine (Tagamet®), fentanyl (Sublimaze®), metoprolol (Lopressor®, Toprol-XL®), St. John's wort, theophylline (Theo-Dur®), tramadol (Ultram®), tryptophan, medicine for migraine headaches (such as sumatriptan, zolmitriptan, Imitrex®, or Zomig®), medicine for seizures (such as phenobarbital, phenytoin, Dilantin®, Luminal®, or Solfoton®), or any other medicine for depression (such as amitriptyline, desipramine, doxepin, fluoxetine, imipramine, lithium, nortriptyline, Aventyl®, Elavil®, Eskalith®, Lithane®, Lithobid®, Norpramin®, Pamelor®, Prozac®, Sinequan®, or Tofranil®). Tell your doctor if you use a blood thinner (such as warfarin or Coumadin®), diuretics or "water pills" (such as furosemide or Lasix®), or a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®).
• Make sure your doctor knows if you are also using atomoxetine (Strattera®), digoxin (Lanoxin®), ketoconazole (Nizoral®), procyclidine (Kemadrin®), risperidone (Risperdal®), or tamoxifen (Nolvadex®). Also tell your doctor if you are using medicine for heart rhythm problems (such as encainide, flecainide, propafenone, quinidine, Enkaid®, Quinaglute®, Rythmol®, or Tambocor®), medicine to treat HIV or AIDS (such as fosamprenavir, ritonavir, Lexiva®, or Norvir®), or any pain or arthritis medicines also called NSAIDs (such as aspirin, celecoxib, ibuprofen, naproxen, Advil®, Aleve®, Bextra®, Celebrex®, Ecotrin®, or Motrin®).
• Do not take Pexeva® tablets if you are also using Paxil® tablets. These medicines should not be taken together because both medicines contains paroxetine.
• Do not drink alcohol while you are using this medicine.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, agitation, restlessness, or mood or mental changes.
• Change in how much or how often you urinate, or problems in urination.
• Changes in behavior, or thoughts of hurting yourself or others.
• Confusion, body weakness, and muscle twitching.
• Extreme lightheadedness or fainting.
• Fast, slow, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Inability to sit or stand still.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Seizures or tremors.
• Trouble sleeping or unusual dreams.
• Unusual bleeding or bruising.
• Weight loss.

If you notice these less serious side effects, talk with your doctor:

• Blurred vision.
• Dizziness, drowsiness, or sleepiness.
• Headache.
• Lack or loss of strength.
• Loss of appetite.
• Menstrual cramps.
• Nausea, dry mouth, diarrhea, constipation, gas, or upset stomach.
• Problems with sex.
• Stuffy or runny nose.
• Sweating.
• Tiredness.
• Vaginal pain or discharge.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have heart disease, kidney disease, liver disease, bleeding problems, bone problems, epilepsy or seizures, high blood pressure, low sodium in the blood, narrow angle glaucoma, or a history of heart attack, stroke, mania, or drug abuse.
• You may need to take this medicine for up to 4 weeks before you feel better. Keep using this medicine for the full treatment time. If you feel that the medicine is not working well, do not take more than your prescribed dose. Call your doctor for instructions.
• For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor or your child's doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• This medicine may cause a serious condition called serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when it is taken with certain medicines. Check with your doctor first before taking any other medicines.
• Check with your doctor right away if you or your child develop the following symptoms during the first few weeks of treatment with paroxetine: inability to sit or stand still, need to keep moving, or restlessness.
• This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Hyponatremia (low sodium in the blood) may occur with this medicine. Stop using the medicine and check with your doctor right away if you or your child have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.
• This medicine may increase the risk of bone fractures. Tell your doctor if you or your child have unexplained bone pain, tenderness, swelling, or bruising. Also, ask your doctor about ways to keep your bones strong to help prevent fractures.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

How to Use This Medicine

Liquid, Tablet, Long Acting Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food. This medicine is usually taken in the morning.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Shake the bottle well before measuring each dose.
• Swallow the tablet and extended-release tablet whole. Do not crush, break, or chew it. Do not use an extended-release tablet that is cracked or chipped.
• Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088