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Generic Name: paroxetine mesylate (par-OX-e-teen MES-i-late)
Brand Name: Pexeva
Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Pexeva outweigh the risks.
Families and caregivers must closely watch patients who take Pexeva. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.
Pexeva is not approved for use in children. Talk with the doctor.
Pexeva is used for:
Treating depression, obsessive-compulsive disorder (OCD), panic disorder, or generalized anxiety disorder (GAD). 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 serotonin, a natural substance in the brain, which helps to improve certain mood problems.
Do NOT use Pexeva if:
- you are allergic to any ingredient in Pexeva
- you are taking or have taken linezolid or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline) within the last 14 days
- you are taking pimozide or thioridazine
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 or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
- if you have a history of seizures, heart problems, liver problems, severe kidney problems, stomach or bowel bleeding, increased eye pressure or glaucoma, diabetes, or metabolism problems
- if you are dehydrated, have low blood sodium levels, or drink alcohol
- if you will be having electroconvulsive therapy (ECT)
- if you are taking a medicine that contains methylene blue
Some MEDICINES MAY INTERACT with Pexeva. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anorexiants (eg, phentermine), cimetidine, fenfluramine derivatives (eg, dexfenfluramine), fentanyl, linezolid, lithium, MAOIs (eg, phenelzine, selegiline), metoclopramide, nefazodone, serotonin 5-HT1 receptor agonists (eg, sumatriptan), sibutramine, SNRIs (eg, venlafaxine), another SSRI (eg, fluoxetine), St. John's wort, tramadol, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma, may occur
- Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
- Antiarrhythmics (eg, flecainide, propafenone, quinidine), astemizole, phenothiazines (eg, chlorpromazine, thioridazine), or terfenadine because severe heart problems, including irregular heartbeat, may occur
- Cyproheptadine, HIV protease inhibitors (eg, ritonavir), phenobarbital, or phenytoin because they may decrease Pexeva's effectiveness
- Aripiprazole, atomoxetine, clozapine, fluoxetine, pimozide, procyclidine, risperidone, theophylline, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Pexeva
- Digoxin or tamoxifen because their effectiveness may be decreased by Pexeva
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 extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pexeva refilled.
- Take Pexeva by mouth with or without food.
- Swallow Pexeva whole. Do not crush or chew before swallowing.
- Taking Pexeva at the same time each day will help you remember to take it.
- Continue to take Pexeva even if you feel well. Do not miss any doses.
- Do not suddenly stop taking Pexeva without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, ringing in the ears, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Pexeva and whenever a change in dose is made.
- If you miss a dose of Pexeva, take it as soon as possible. If it almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
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. These effects may be worse if you take it with alcohol or certain medicines. Use Pexeva with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pexeva; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do not drink alcohol while you are taking Pexeva.
- Several weeks may pass before your symptoms get better. Do NOT take more than the recommended dose, change your dose, or use Pexeva for longer than prescribed without checking with your doctor.
- Children, teenagers, and young adults who take Pexeva may be at increased risk of suicidal thoughts or actions. Closely watch all patients who take Pexeva. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- If your doctor tells you to stop taking Pexeva, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking Pexeva.
- Pexeva may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Pexeva. Your risk may be greater if you take Pexeva with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Certain antidepressants, including Pexeva, may increase the risk of bleeding. Sometimes, bleeding can be life-threatening. Discuss any questions or concerns with your doctor.
- Some people may be at risk for eye problems from Pexeva. Your doctor may want you to have an eye exam to see if you are at risk for these eye problems. Call your doctor right away if you have eye pain, vision changes, or swelling or redness in or around the eye.
- Pexeva may affect fertility in some men. Discuss any questions or concerns with your doctor.
- Use Pexeva with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
- Pexeva may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Pexeva.
- PREGNANCY and BREAST-FEEDING: Pexeva may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Pexeva while you are pregnant. Pexeva is found in breast milk. If you are or will be breast-feeding while you take Pexeva, check with your doctor. Discuss any possible 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth; gas; increased sweating; increased urination; loss of appetite; nausea; nervousness; numbness or tingling of the skin; stomach upset; trouble sleeping; weakness; yawning.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; decreased sexual desire or ability; exaggerated reflexes; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; memory loss; new or worsening mental or mood changes (eg, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still); persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; severe or persistent headache or dizziness; significant weight loss; stomach pain; suicidal thoughts or attempts; tremor; unusual bone pain or unexplained swelling, tenderness, or bruising; unusual bruising or bleeding; unusual weakness; worsening of depression.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Pexeva:
Store Pexeva at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pexeva out of the reach of children and away from pets.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Pexeva or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Pexeva. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Pexeva. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Pexeva.