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 Generic Name: Paroxetine Tablets (pa-ROX-e-teen)
Brand Name: Paxil
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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 Paroxetine 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 shut 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.
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Paroxetine is taken 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 might and be taken for other conditions as determined by your physician.
Paroxetine is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of certain general substances in the brain, which help to elevate moods.
Do NOT use Paroxetine if:
- you are allergic to any ingredient in Paroxetine
- you are currently taking a phenothiazine (eg, thioridazine) or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
Contact your physician or health care provider right away if any of these apply to you.
Before taking Paroxetine :Some medical conditions might interact with Paroxetine . Tell your physician 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 or mania, have thoughts of suicide, or have attempted suicide
- if you have severe liver or kidney disease, an illness that alters your metabolism or blood circulation response, or have had gastrointestinal bleeding
- if you have a history of narrow-angle glaucoma
Some MEDICINES MIGHT INTERACT with Paroxetine . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Cyproheptadine, risperidone, or sumatriptan because the
effectiveness of Paroxetine might be decreased.
- Anorexiants (eg, phentermine), dextromethorphan, fenfluramine and its derivatives, l-tryptophan, MAO inhibitors (eg, phenelzine), selegiline, St. John's wort, tramadol, beta-blockers (eg, metoprolol), buspirone, butyrophenones (eg, haloperidol), cimetidine, clonazepam, linezolid, lithium, metoclopramide, nefazodone, sibutramine, sumatriptan, trazodone, or zolpidem because side effects such as serotonin syndrome and central nervous system toxicity might occur.
- Astemizole, dextromethorphan,
phenothiazines (eg, thioridazine), St. John's wort, terfenadine, tramadol, anticholinergics (eg, oxybutynin, scopolamine), anticoagulants (eg, warfarin), aripiprazole, beta-blockers (eg, metoprolol), butyrophenones (eg, haloperidol), clozapine, galantamine, H1 antagonists (eg, diphenhydramine), molindone, norepinephrine reuptake inhibitors (eg, atomoxetine), nonsteroidal anti-inflammatory agents (NSAIDs) (eg, ibuprofen), pimozide, propafenone, risperidone, selegiline, trazodone, or tricyclic antidepressants (eg, amitriptyline) because side effects associated with these medicines might be increased by Paroxetine
- Atypical antipsychotics (eg, risperidone), because the risk of thromboembolic events (clots) might be increased
- Barbiturate anesthetics (eg, thiopental)
used for anesthesia during electroconvulsive therapy (ECT) because the risk of spontaneous seizure is increased
This might not be a complete list of all interactions that might occur. Ask your health care provider if Paroxetine might interact with other medicines that you use. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Paroxetine :Use Paroxetine as directed by your physician. Check the label on the medicine for exact dosing instructions.
- Paroxetine comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Paroxetine refilled.
- Paroxetine might be taken on an hollow stomach or with food.
- Paroxetine is generally taken in the morning.
- Symptoms generally improve within 1 to 4 weeks. Continue taking your medicine even though you feel better.
- If you miss a dose of Paroxetine and you are taking it in the morning, use 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 natural dosing schedule. If you miss a dose and you are taking one dose every day at bedtime and do not remember until the next day, skip the missed dose and go back to your natural dosing schedule. Do not use 2 doses at one time. If you miss more than one dose, contact your physician or pharmacist.
Ask your health care provider any questions you might have about how to use Paroxetine .
Important safety information:
- Paroxetine might cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Paroxetine . Taking Paroxetine alone, with certain other medicines, or with alcohol might lessen your ability to
drive or perform other potentially dangerous tasks.
- Do NOT suddenly stop taking Paroxetine . Suddenly stopping Paroxetine might cause irritability, a state of feeling unwell or sad, 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, and possibly adults. This risk might 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 shut 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 Paroxetine .
- Additional monitoring of your condition is recommended at the start of treatment with Paroxetine and whenever a change to your dose is made.
- LAB TESTS, including liver function, kidney function, and complete blood cell counts, might be performed to monitor your progress or to check for side effects. Be sure to store your appointments.
- Paroxetine is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
- If you experience a prolonged or painful erection, stop taking Paroxetine , and seek immediate medical attention or fixed problems can occur.
- PREGNANCY and BREAST-FEEDING: Paroxetine might cause harm to the fetus. If you think you might be pregnant, discuss with
your physician the benefits and risks of taking Paroxetine during pregnancy. Paroxetine is excreted in breast milk. If you are or will be breast-feeding while you are taking Paroxetine , check with your physician or pharmacist to discuss the risks to your baby.
Possible side effects of Paroxetine :All medicines might cause side effects, however many people have no, or minor, side effects. Check with your physician if any of these most GENERAL side effects persist or become bothersome: Abnormal dreams; abnormal ejaculation; abnormal skin sensations; agitation; anxiety; back pain; blurred vision; constipation;
decreased appetite; decreased sex drive; diarrhea; difficulty concentrating;
difficulty reaching climax/orgasm; dizziness; drowsiness; dry mouth; fatigue; female genital disorders; flushing; gas; headache;
impotence; inability to sleep; infection (fever, chills, sore throat); inflamed sinuses;
light-headedness; muscle pain; muscle twitch; nausea; nervousness; painful period; rash; runny nose; sleepiness;
sore throat; stomach pain; sweating; temporary loss of personal reality; urinary frequency; urination disorder; vomiting; weakness; 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); abnormal bleeding;
breathing problems; chest pain; extreme mood swings; heart problems; pounding in the chest; prolonged, painful erection; thoughts of hurting yourself; tremors; unusual bleeding or bruising; worsening of mood or mental state; seizures; worsening of depression.
This is not a complete list of all side effects that might occur. If you have questions or need medical advice
about side effects, contact your physician or health care provider. You might 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 might include confusion; difficulty breathing; dilated pupils; excessive sweating; fainting; fast heartbeat; fever;
loss of consciousness; severe drowsiness; twitching; seizures. Do not use more medicine than prescribed unless advised to do so by your health care provider.
Proper storage of Paroxetine :Store Paroxetine at room temperature, between 68 and 77 degrees F
(20 and 25 degrees C). Store away from heat, moisture, and thin. Do not store in the bathroom. Brief storage at temperatures
between 59 and 86 degrees F
(15 and 30 degrees C) is permitted. Store Paroxetine out of the reach of children and away from pets.
General information:
- If you have any questions about Paroxetine , please talk with your physician, pharmacist, or other health care provider.
- Paroxetine is to be taken 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 physician.
This information is a summary only. It does not contain all information about Paroxetine . If you have questions about the medicine you are taking or would like more information, check with your physician, pharmacist, or other health care provider.
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