Pexeva
 Pexeva

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Pexeva

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

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 purposes other than those listed in this medication guide.

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

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

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 paroxetine 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 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;

  • seizures or epilepsy;

  • bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts.

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

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. Symptoms of a paroxetine overdose 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.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, other medication for depression or anxiety). They can add to sleepiness caused by paroxetine.

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.

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. 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; or

  • 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; or

  • dry mouth, yawning, or 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.

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.

Before taking paroxetine, 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), or tryptophan (also called L-tryptophan);

  • heart rhythm medication such as flecainide (Tambocor) or propafenone (Rhythmol);

  • a blood thinner such as warfarin (Coumadin);

  • any other antidepressants such as amitriptyline (Elavil), citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), or sertraline (Zoloft);

  • a phenothiazine such as prochlorperazine (Compazine), chlorpromazine (Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), and others; or
  • almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig).

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

There may be other drugs not listed that can affect 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 has additional information about paroxetine written for health professionals that you may read.

What does my medication look like?

Paroxetine is available with a prescription under the brand names Paxil, Paxil CR and Pexeva. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Paxil 10 mg--oval, yellow, film-coated scored tablets

  • Paxil 20 mg--oval, pink, film-coated scored tablets

  • Paxil 30 mg--oval, blue, film-coated scored tablets

  • Paxil 40 mg--oval, green, film-coated scored tablets

  • Paxil CR 12.5 mg--round yellow, film-coated tablets

  • Paxil CR 25 mg--round, pink, film-coated tablets

  • Paxil CR 37.5 mg-round, blue, film-coated tablets

  • Paxil 10 mg/5 mL-orange-colored, orange-flavored oral suspension

  • 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 1996-2006 Cerner Multum, Inc. Version: 15.01. Revision Date: 10/13/06 12:44:26 PM.



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