Why is Paxil prescribed?
Paxil relieves a variety of emotional problems. It can be prescribed for
serious, continuing depression that interferes with your ability to
function. Symptoms of this type of depression often include changes in
appetite and sleep patterns, a persistent low mood, loss of interest in
people and activities, decreased sex drive, feelings of guilt or
worthlessness, suicidal thoughts, difficulty concentrating, and slowed
thinking.
Paxil is also used to treat obsessive-compulsive disorder (OCD), a disease
marked by unwanted, but stubbornly persistent thoughts, or unreasonable
rituals you feel compelled to repeat.
In addition, Paxil is prescribed for panic disorder, a crippling emotional
problem characterized by sudden attacks of at least four of the following
symptoms: palpitations, sweating, shaking, numbness, chills or hot flashes,
shortness of breath, a feeling of choking, chest pain, nausea or abdominal
distress, dizziness or faintness, feelings of unreality or detachment,
fear of losing control, or fear of dying.
Paxil can be prescribed for generalized anxiety disorder, a disease marked
by excessive anxiety and worry that persists for at least 6 months and
can't be easily controlled. True cases of generalized anxiety disorder are
accompanied by at least three of the following symptoms: restlessness or a
keyed-up or on-edge feeling, a tendency to tire easily, difficulty
concentrating or spells when the mind goes blank, irritability, muscle
tension, or sleep disturbance.
Paxil can be used in the treatment of social anxiety disorder (also known
as social phobia), a condition marked by shyness or stage fright so
intense that it interferes with an individual's work and social life.
Paxil is also prescribed for post-traumatic stress disorder—a crippling
condition that sometimes develops in reaction to a disastrous or
horrifying experience. Symptoms, which stubbornly refuse to abate, include
unwanted memories and dreams, intense distress when confronted with
reminders of the event, a general numbing of interest and enjoyment,
jumpiness, irritability, poor sleep, and loss of concentration.
Paxil CR, the controlled-release version, is prescribed for major
depression, panic disorder, social anxiety disorder, and severe
premenstrual symptoms classified as premenstrual dysphoric disorder.
Paxil belongs to the class of drugs known as selective serotonin reuptake
inhibitors (SSRIs). Serotonin is one of the chemical messengers believed
to govern moods. Ordinarily, it is quickly reabsorbed after its release at
the junctures between nerves. Reuptake inhibitors such as Paxil slow this
process, thereby boosting the levels of serotonin available in the brain.
(http://www.pdrhealth.com/drugs/rx/rx-mono.aspx?contentFileName=Pax1319.htm
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What advice
can you provide to adults using Paxil?
It is vital that patients are not panicked into stopping their medication
suddenly. The advice to adults using Paxil has not changed. Paxil has been
demonstrated to be effective in treatment of major depressive disorder,
obsessive compulsive disorder, panic disorder, social anxiety disorder,
generalized anxiety disorder, and post-traumatic stress disorder in adults.
Anyone taking Paxil who is feeling unwell or is concerned about the
treatment should consult his or her doctor.
Why would Paxil cause these reactions in children and not in adults?
Childhood depression is different from adult depression. The reasons are
not clear but could relate to the continuing development of the child’s
brain. It has been difficult to show effectiveness in children of
antidepressants known to work in adults and a number of effective adult
antidepressants have not been shown to work in childhood depression
Children may also react very differently to some medicines and some side
effects over a range of drugs are seen in children that are not seen in
adults.
However, the Agency has not yet definitively determined that there is an
increased risk of suicidal behavior in pediatric patients with MDD treated
with Paxil.
Are there drugs approved for the treatment of depression in children?
Prozac (fluoxetine) is the only drug approved for the treatment of major
depressive disorder in children. It is approved in children 8 to 18 years
of age.
What is Paxil?
Paxil (paroxetine) is one of a class of medicines called Selective
Serotonin Reuptake Inhibitors (SSRIs). These drugs increase the activity
of an important brain chemical called serotonin, a chemical know to be
deficient in patients with MDD.
How long has Paxil been on the market?
Paxil was first approved in the United States on December 29, 1992, for
the treatment of depression.
(http://www.fda.gov/cder/drug/infopage/
paroxetine/paxilQ&A.htm)
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Important information about Paxil
You may have thoughts about suicide when you first
start taking an antidepressant, especially if you are younger than 24 years
old. Your doctor will need to check you at regular visits for at least the
first 12 weeks of treatment.
Call your doctor at once if you have any new or
worsening symptoms 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. Paxil 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 Paxil, do not stop taking the medication without first talking to
your doctor. Do not take Paxil 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). (http://www.drugs.com/paxil.html )
Before taking Paxil
Do not use Paxil 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 Paxil. You must wait at least 14
days after stopping an MAO inhibitor before you can take Paxil. After you
stop taking Paxil, you must wait at least 14 days before you start taking an
MAOI.
Before taking Paxil, tell your doctor if you are
allergic to any drugs, or if you have:
- liver or kidney disease;
- a bleeding or blood clotting disorder;
- seizures or epilepsy; or
- bipolar disorder (manic depression), or a
history of drug abuse or suicidal thoughts.
If you have any of these conditions, you may need a
dose adjustment or special tests to safely use Paxil.
You may have thoughts about suicide while taking an
antidepressant, especially if you are younger than 24 years old. Tell your
doctor if you have worsening depression or suicidal thoughts during the
first several weeks of treatment, or whenever your dose is changed.
Your family or other caregivers should also 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.
FDA pregnancy category D. Paxil 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 Paxil, do not stop taking the medication without first talking to
your doctor. Paxil 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. (http://www.drugs.com/paxil.html)
Why should Paxil not be prescribed?
Dangerous and even fatal reactions are possible
when Paxil is combined with thioridazine or drugs classified as monoamine
oxidase (MAO) inhibitors, such as the antidepressants phenelzine and
tranylcypromine. Never take Paxil with any of these medications, or within 2
weeks of starting or stopping use of an MAO inhibitor. You'll also need to
avoid Paxil if it gives you an allergic reaction.
Most important fact about Paxil
our symptoms may seem to
improve within 1 to 4 weeks after beginning treatment with Paxil. Even if
you feel better, continue to take the medication as long as your doctor
tells you to do so. (http://www.pdrhealth.com/drugs/rx/rx-mono.aspx?contentFileName=Pax1319.html&contentName=Paxil&contentId=419)
Why is FDA recommending
that Paxil not be used for the treatment of pediatric major depressive
disorder (MDD)?
FDA is currently reviewing reports of an increased risk of suicidal thinking
and suicide attempts related to the use of the drug Paxil in children and
adolescents under the age of 18 with MDD. Although FDA has not completed
this evaluation, we are recommending that Paxil not be used in the treatment
of pediatric MDD. There is no evidence that Paxil is effective in children
or adolescents with MDD.
Should children using Paxil stop taking it immediately?
It is very important that children and adolescents not stop taking Paxil
suddenly, as there is a risk of discontinuation effects. Caretakers of
children and adolescents currently taking Paxil should consult their doctor
to discuss the best course of action. If they are doing well on Paxil, their
doctor may advise that they complete their course of treatment. If their
doctor advises that Paxil should be stopped, this should be done gradually
to minimize the risk of discontinuation effects. If the dose is not reduced
gradually, there is a greater chance of experiencing side effects. If severe
unwanted side effects occur, it may be necessary to start taking Paxil again
or increase the dose before subsequently decreasing the dose more gradually.
What data is the advice based on?
Three well-controlled clinical trials carried out in children (under 18
years of age) with MDD compared the effect of Paxil and placebo (sugar pills)
and found that Paxil did not work any better than placebo in the treatment
of MDD.
Based on the results of the new analyses of safety data from pediatric
studies, it was found that certain possibly suicide-related behaviors,
including suicidal thoughts and attempts, were more common in children
receiving Paxil. The risk of these events in the study was about 3 times
greater with Paxil compared to placebo. There were no deaths in these trials.
Is Paxil approved for the
treatment of children and adolescents?
The FDA has not approved Paxil for the treatment of MDD or any other
indication in pediatric patients. However, the FDA does not regulate the
practice of medicine and physicians may use a drug in ways other than
indicated on the labeling when, in their professional judgment, it is
warranted in a particular case.
My child is taking Paxil for a condition other than depression. What should
I do?
Paxil has not been approved for use in children under the age of 18 for any
indication, but your child may have been prescribed Paxil for an off-label
use. As stated above, physicians may use a drug in ways other than indicated
on the labeling when, in their professional judgment, it is warranted in a
particular case. If your child is taking Paxil, you should consult with your
doctor before making any changes. It is very important that Paxil not be
stopped abruptly since discontinuation effects may occur.
What does this mean for the use of Paxil in adults?
Paxil is approved for use in adults for the following indications: major
depressive disorder, obsessive compulsive disorder, panic disorder, social
anxiety disorder, generalized anxiety disorder, and post-traumatic stress
disorder. Extensive analyses of the data from studies of Paxil in adults and
from postmarketing adverse event reports have not revealed an increase in
the rate of suicidal thoughts or suicide attempts compared to placebo.
(http://www.fda.gov/cder/drug/infopage/paroxetine/paxilQ&A.htm) |
How should you take Paxil?
Paxil is taken
once a day, with or without food, usually in the morning. Inform your
doctor if you are taking or plan to take any prescription or over-the-counter
drugs, since they may interact unfavorably with Paxil. Shake the oral
suspension well before using. Paxil CR should be swallowed whole; it
should not be chewed or crushed.
If you miss a dose...
Skip the forgotten dose and go back to your regular schedule with the next
dose. Do not take a double dose to make up for the one you missed.
Storage instructions...
Paxil tablets and suspension can be stored at room temperature.
(http://www.pdrhealth.com/drugs/rx/rx-mono.aspx?contentFileName=Pax1319.htm
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Special warnings about Paxil
In clinical studies, antidepressants increased the risk of suicidal
thinking and behavior in children and adolescents with depression and
other psychiatric disorders. Anyone considering the use of Paxil or any
other antidepressant in a child or adolescent must balance this risk with
the clinical need. Paxil has not been studied in children or adolescents
and is not approved for treating anyone less than 18 years old.
Additionally, the progression of major depression is associated with a
worsening of symptoms and/or the emergence of suicidal thinking or
behavior in both adults and children, whether or not they are taking
antidepressants. Individuals being treated with Paxil and their caregivers
should watch for any change in symptoms or any new symptoms that appear
suddenly—especially agitation, anxiety, hostility, panic, restlessness,
extreme hyperactivity, and suicidal thinking or behavior—and report them
to the doctor immediately. Be especially observant at the beginning of
treatment or whenever there is a change in dose.
Paxil should be used cautiously by people with a history of manic
disorders and those with high pressure in the eyes (glaucoma).
If you have a history of seizures, make sure your doctor knows about it.
Paxil should be used with caution in this situation. If you develop
seizures once therapy has begun, the drug should be discontinued.
If you have a disease or condition that affects your metabolism or blood
circulation, make sure your doctor is aware of it. Paxil should be used
cautiously in this situation.
Paxil may impair your judgment, thinking, or motor skills. Do not drive,
operate dangerous machinery, or participate in any hazardous activity that
requires full mental alertness until you are sure the medication is not
affecting you in this way.
Antidepressants such as Paxil could potentially cause stomach bleeding,
especially when combined with nonsteroidal anti-inflammatory drugs (NSAIDs)
such as aspirin, ibuprofen, naproxen, and ketoprofen. Consult your doctor
before combining Paxil with NSAIDs or blood-thinning drugs.
Paxil contains paroxetine, which is associated with serotonin syndrome.
Symptoms include agitation, confusion, sweating, hallucinations, abnormal
reflexes, muscle spasms, shivering, rapid heartbeat, and tremors. Contact
your doctor immediately if you experience any of these symptoms.
It's best to avoid an abrupt discontinuation of Paxil therapy. It can lead
to symptoms such as dizziness, abnormal dreams, and tingling sensations.
To prevent such problems, your doctor will reduce your dose gradually.(http://www.pdrhealth.com/drugs/rx/rx-mono.aspx?contentFileName=Pax1319.html&contentName=Paxil&contentId=419)
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