* Generic Name: paroxetine hydrochloride
* Brand Name: Paxil
* What is paroxetine?
* What are the possible side effects of paroxetine?
* What is the most important information I should know about
paroxetine?
* What should I discuss with my healthcare provider before taking
paroxetine?
* How should I take paroxetine?
* What happens if I miss a dose?
* What happens if I overdose?
* What should I avoid while taking paroxetine?
* What other drugs will affect paroxetine?
* Where can I get more information?
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 be unbalanced in people with
depression, anxiety, or other disorders.
Paroxetine is used to treat depression, obsessive-compulsive
disorder, anxiety disorders, post-traumatic stress disorder
(PTSD), and premenstrual dysphoric disorder (PMDD).
The Brisdelle brand of paroxetine is used to treat hot flashes
related to menopause. Brisdelle is not for treating any other
conditions.
Paroxetine may also be used for purposes not listed in this medication
guide.
What are the possible side effects of paroxetine?
Get emergency medical help if you have signs of an allergic reaction:
skin rash or hives; difficult breathing; swelling of your face, lips,
tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or
behavior changes, anxiety, panic attacks, trouble sleeping, or if
you feel impulsive, irritable, agitated, hostile, aggressive, restless,
hyperactive (mentally or physically), more depressed, or have thoughts
about suicide or hurting yourself.
Call your doctor at once if you have:
* racing thoughts, decreased need for sleep, unusual risk-taking
behavior, feelings of extreme happiness or sadness, being more
talkative than usual;
* blurred vision, tunnel vision, eye pain or swelling, or
seeing halos around lights;
* unusual bone pain or tenderness, swelling or bruising;
* changes in weight or appetite;
* easy bruising, unusual bleeding (nose, mouth, vagina, or
rectum), coughing up blood;
* high levels of serotonin in the body--agitation,
hallucinations, fever, fast heart rate, overactive reflexes,
nausea, vomiting, diarrhea, loss of coordination, fainting;
* low levels of sodium in the body--headache, confusion, slurred
speech, severe weakness, loss of coordination, feeling
unsteady;
* severe nervous system reaction--very stiff (rigid) muscles, high
fever, sweating, confusion, fast or uneven heartbeats, tremors,
fainting; or
* severe skin reaction--fever, sore throat, swelling in your face
or tongue, burning in your eyes, skin pain, followed by a red or
purple skin rash that spreads (especially in the face or upper
body) and causes blistering and peeling.
Common side effects may include:
* vision changes;
* weakness, drowsiness, dizziness;
* sweating, anxiety, shaking;
* sleep problems (insomnia);
* loss of appetite, constipation;
* dry mouth, yawning; or
* decreased sex drive, impotence, or difficulty having an
orgasm.
This is not a complete list of side effects and others may occur. Call
your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about paroxetine?
You should not use paroxetine if you are also taking pimozide or
thioridazine.
Do not use paroxetine within 14 days before or 14 days after you have
used an MAO inhibitor, such as isocarboxazid, linezolid,
methylene blue injection, phenelzine, rasagiline, selegiline,
or tranylcypromine.
Some young people have thoughts about suicide when first taking an
antidepressant. Stay alert to changes in your mood or symptoms. Report
any new or worsening symptoms to your doctor
Seek medical attention right away if you have symptoms such as:
agitation, hallucinations, muscle stiffness, twitching, loss of
coordination, dizziness, warmth or tingly feeling, nausea, vomiting,
diarrhea, fever, sweating, tremors, racing heartbeats, or a seizure
(convulsions).
Paxil Patient Information including How Should I Take
Depression Overview:What is Depression?
Understanding Depression Slideshow
RxList
Take the Depression Quiz
Depression:Tips for Exercise Diet and Stress Reduction
Depression Tips Slideshow Pictures
What should I discuss with my healthcare provider before taking paroxetine?
You should not use this medicine if you are allergic to paroxetine, or
if you are also taking pimozide or thioridazine.
Do not use an MAO inhibitor within 14 days before or 14 days after you
take paroxetine. A dangerous drug interaction could occur. MAO
inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline,
selegiline, and tranylcypromine. After you stop taking paroxetine you
must wait at least 14 days before you start taking an MAO inhibitor.
To make sure paroxetine is safe for you, tell your doctor if you have:
* heart disease, high blood pressure, history of stroke;
* liver or kidney disease;
* a bleeding or blood clotting disorder;
* seizures or epilepsy;
* bipolar disorder (manic depression), or a history of drug
abuse or suicidal thoughts;
* narrow-angle glaucoma; or
* low levels of sodium in your blood.
Some young people have thoughts about suicide when first taking an
antidepressant. Your doctor should check your progress at regular
visits. Your family or other caregivers should also be alert to changes
in your mood or symptoms.
Taking an paroxetine during pregnancy may cause serious lung problems,
a heart defect, or other complications in the baby. However, you may
have a relapse of depression or other treated condition if you stop
taking your antidepressant. Tell your doctor right away if you become
pregnant. Do not start or stop taking this medicine during pregnancy
without your doctor's advice.
Do not use Brisdelle if you are pregnant.
Paroxetine can pass into breast milk and may cause side effects in the
nursing baby. You should not breast-feed while using this medicine.
Paroxetine is not approved for use by anyone younger than 18 years old.
How should I take paroxetine?
Follow all directions on your prescription label. Your doctor may
occasionally change your dose. Do not take this medicine in larger or
smaller amounts or for longer than recommended.
Do not crush, chew, or break an extended-release tablet. Swallow it
whole.
Shake the oral suspension (liquid) well just before you measure a dose.
Measure liquid medicine with the dosing syringe provided, or with a
special dose-measuring spoon or medicine cup. If you do not have a
dose-measuring device, ask your pharmacist for one.
It may take up to 4 weeks before your symptoms improve. Keep using the
medication as directed and tell your doctor if your symptoms do not
improve.
Do not stop using paroxetine suddenly, or you could have unpleasant
withdrawal symptoms. Ask your doctor how to safely stop using
paroxetine. Follow your doctor's instructions about tapering your dose.
Store at room temperature away from moisture, heat, and light.
Paxil Patient Information including If I Miss a Dose
Depression Overview:What is Depression?
Understanding Depression Slideshow
RxList
Take the Depression Quiz
Depression:Tips for Exercise Diet and Stress Reduction
Depression Tips Slideshow Pictures
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if
it is almost time for your next scheduled dose. Do not take extra
medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at
1-800-222-1222. An overdose of paroxetine can be fatal.
What should I avoid while taking paroxetine?
Drinking alcohol with this medicine can cause side effects.
Ask your doctor before taking a nonsteroidal anti-inflammatory drug
(NSAID) for pain, arthritis, fever, or swelling. This includes
aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib
(Celebrex), diclofenac, indomethacin, meloxicam, and
others. Using an NSAID with paroxetine may cause you to bruise or bleed
easily.
Paroxetine may impair your thinking or reactions. Be careful if you
drive or do anything that requires you to be alert.
What other drugs will affect paroxetine?
Taking paroxetine with other drugs that make you sleepy can worsen this
effect. Ask your doctor before taking a sleeping pill, narcotic
medication, muscle relaxer, or medicine for anxiety, depression, or
seizures.
Tell your doctor about all your current medicines and any you start or
stop using, especially:
* cimetidine (Tagamet), St. John's wort,
tamoxifen, tryptophan (sometimes called
L-tryptophan), warfarin (Coumadin, Jantoven);
* heart rhythm medicine;
* HIV or AIDS medications;
* certain medicines to treat narcolepsy or ADHD--amphetamine,
atomoxetine, dextroamphetamine, Adderall, Dexedrine,
Evekeo, Vyvanse, and others;
* narcotic pain medicine--fentanyl, tramadol;
* medicine to treat anxiety, mood disorders, thought disorders, or
mental illness--such as buspirone, lithium, other
antidepressants, or antipsychotics;
* migraine headache medicine--sumatriptan, rizatriptan,
zolmitriptan, and others; or
* seizure medicine--phenobarbital, phenytoin.
This list is not complete. Other drugs may interact with paroxetine,
including prescription and over-the-counter medicines, vitamins, and
herbal products. Not all possible interactions are listed in this
medication guide.
Where can I get more information?
Your pharmacist can provide more information about paroxetine.
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