Pexeva

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Pexeva


Generic Name: Paroxetine Mesylate (pa-ROX-e-teen MEH-sill-ate)
Brand Name: Pexeva

The risk of suicidal thinking and behavior was increased by antidepressants in short-term studies in children and adolescents with certain psychiatric disorders. Anyone considering the use of Pexeva or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be watched closely for worsening of symptoms, suicidal thoughts and behavior, or unusual behavior changes. Families and caregivers should be aware of the need for close observation and communication with the prescriber. Results from several studies in children and adolescents with certain psychiatric disorders have revealed a greater risk of side effects related to suicidal thinking and behavior during the first few months of treatment with antidepressants.


Pexeva is used for:

Treating depression, obsessive-compulsive disorder (OCD), generalized and social anxiety disorders, posttraumatic stress disorder, and panic disorders with or without the fear of being in open or public places. It may also be used for other conditions as determined by your doctor.

Pexeva is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of certain natural substances in the brain, which help to elevate moods.

Do NOT use Pexeva if:

  • you are allergic to any ingredient in Pexeva
  • you are taking dextromethorphan, fenfluramine, nefazodone, pimozide, selegiline, sibutramine, St. John"s wort, thioridazine, tramadol, or tryptophan
  • you have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pexeva :

Some medical conditions may interact with Pexeva . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of seizures, mania, or thoughts of suicide, or you have attempted suicide
  • if you have severe liver or kidney disease, an illness that alters your metabolism or blood circulation response, or a history of stomach or intestinal bleeding
  • if you have a history of narrow-angle glaucoma
  • if you are dehydrated

Some MEDICINES MAY INTERACT with Pexeva . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Cyproheptadine because the effectiveness of Pexeva may be decreased
  • Anorexiants (eg, phentermine, fenfluramine), cimetidine, dextromethorphan, linezolid, lithium, MAO inhibitors (eg, phenelzine), metoclopramide, nefazodone, selegiline, St. John"s wort, serotonin 5-HT receptor agonists (eg, sumatriptan, sibutramine, trazodone, or tryptophan because side effects, such as serotonin syndrome and central nervous system toxicity, may occur
  • Antiarrhythmics (eg, propafenone, flecainide, quinidine), anticoagulants (eg, warfarin), aspirin, aripiprazole, clozapine, digoxin, diuretics (eg, furosemide), H1 antagonists (eg, astemizole), norepinephrine reuptake inhibitors (eg, atomoxetine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), phenothiazines (eg, thioridazine), tramadol, pimozide, procyclidine, risperidone, theophylline, or tricyclic antidepressants (eg, amitriptyline) because side effects associated with these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pexeva may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pexeva :

Use Pexeva as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Pexeva comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Pexeva refilled.
  • Pexeva may be taken on an empty stomach or with food.
  • Pexeva is usually taken in the morning.
  • Symptoms usually improve within 1 to 4 weeks. Continue taking your medicine even though you feel better.
  • If you miss a dose of Pexeva and you are taking it in the morning, take it during the afternoon if you remember. If you do not remember until the next morning, skip the missed dose and go back to your regular dosing schedule. If you miss a dose and you are taking one dose daily at bedtime and do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than one dose, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Pexeva .

Important safety information:

  • Pexeva may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pexeva . Using Pexeva alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • Do NOT suddenly stop taking Pexeva . Suddenly stopping Pexeva may cause irritability, a state of feeling unwell or unhappy, agitation, dizziness, electric shock sensations, anxiety confusion, headache, lack of energy, mood swings, inability to sleep, or mild mania. If therapy is to be discontinued, it should be gradually decreased.
  • Antidepressants can increase suicidal thoughts and actions in some children and teenagers. Adults taking Pexeva may also be affected. This risk may be higher in individuals with bipolar illness (also called manic-depressive illness), a family history of bipolar illness, or a history of attempting suicide. Pay close attention to changes in moods or actions, especially if changes occur suddenly. Contact your health care provider right away if any of the following effects occur or worsen: depression, anxiety, restlessness or irritability, panic attacks, thoughts or attempts of suicide, or other unusual changes in behavior or mood.
  • Avoid drinking alcohol while taking Pexeva .
  • Pexeva will add to the drowsiness effect of other medicines. Check the labels of all your medicines for ingredients that may cause drowsiness. Ask your pharmacist if you are unsure which products may cause drowsiness. Do NOT start any new medicines without checking with your doctor or pharmacist.
  • Additional monitoring of your condition is recommended at the start of treatment with Pexeva and whenever a change to your dose is made.
  • Pexeva contains the same active ingredient as Paxil. Do not take Pexeva with Paxil.
  • If you experience a prolonged or painful erection, stop using Pexeva , and seek immediate medical attention or permanent problems can occur.
  • LAB TESTS, including liver function, kidney function, and complete blood count, may be performed to monitor your progress or to check for side effects. Be sure to keep your appointments.
  • Caution is advised when using Pexeva in the ELDERLY because they may be more sensitive to its effects, especially decreased blood sodium levels.
  • Use Pexeva with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Pexeva may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Pexeva during pregnancy. Pexeva is excreted in breast milk. If you are or will be breast-feeding while you are using Pexeva , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pexeva :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal dreams; abnormal ejaculation; abnormal skin sensations; blurred vision; constipation; decreased appetite; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; impotence; nausea; nervousness; painful period; runny nose; sleepiness; sore throat; stomach pain; sweating; vomiting; weakness; weight loss; yawning.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; chest pain; confusion; extreme mood swings; fever, chills, or persistent sore throat; hallucinations; heart problems; fast or irregular heartbeat; mental or mood changes; new or worsening agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, sleeplessness, exaggerated feeling of well being, or inability to sit still; pounding in the chest; prolonged, painful erection; suicidal thoughts or attempts; tremors; unexplained shivering; unusual bleeding or bruising; urinary changes; seizures; vision changes; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include: confusion; difficulty breathing; dilated pupils; excessive sweating; fainting; fast or irregular heartbeat; fever; loss of consciousness; severe drowsiness; twitching; seizures. Do not take more medicine than prescribed unless advised to do so by your health care provider.

Proper storage of Pexeva :

Store Pexeva at room temperature, at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Pexeva out of the reach of children and away from pets.

General information:

  • If you have any questions about Pexeva , please talk with your doctor, pharmacist, or other health care provider.
  • Pexeva is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pexeva . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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