Paxil® (paroxetine)
Brand
names:
Paxil®
-
Tablets
(immediate release): 10 mg, 20 mg, 30 mg, 40 mg
-
Liquid
suspension: 10 mg/5 ml
Paxil
CR®
Pexeva®
Generic
name: paroxetine (pa
ROKS e teen)
Medication
class: Selective serotonin reuptake inhibitor (SSRI) antidepressant
All FDA black box
warnings are at the end of this fact sheet. Please review
before taking this medication.
What
is Paxil® and what does it treat?
Paroxetine
is an antidepressant medication that works in the brain. It is
approved for the treatment of major depressive disorder (MDD),
generalized anxiety disorder (GAD), social anxiety disorder (social
phobia), panic disorder, obsessive compulsive disorder (OCD),
posttraumatic stress disorder (PTSD), and premenstrual dysphoric
disorder (PMDD).
Symptoms
of depression include:
-
Depressed
mood - feeling sad, empty, or tearful
-
Feeling
worthless, guilty, hopeless, and helpless
-
Loss
of interest or pleasure in your usual activities
-
Sleep
and eat more or less than usual (for most people it is less)
-
Low
energy, trouble concentrating, or thoughts of death (suicidal
thinking)
-
Psychomotor
agitation (‘nervous energy’)
-
Psychomotor
retardation (feeling like you are moving and thinking in slow
motion)
-
Suicidal
thoughts or behaviors
Generalized
Anxiety Disorder (GAD) occurs
when a person experiences excessive anxiety or worry for at least six
months. Other symptoms include
-
Restlessness
-
Fatigue
(low energy, feeling tired all the time)
-
Difficulty
concentrating
-
Irritability
-
Muscle
tension
-
Sleep
disturbance (difficulty falling asleep or waking up in the middle of
the night)
Social
phobia/social anxiety disorder is a fear of situations where one may
feel as if they are being judged by others. Symptoms include:
-
Blushing
-
Difficulty
talking
-
Nausea
-
Sweating
-
Shaking
Panic
Disorder occurs when a person experiences unexpected and repeated
episodes of intense fear. These episodes have physical symptoms
including chest pain, shortness of breath, heart palpitations,
sweating, dizziness, and nausea. Fear of future episodes is also part
of panic disorder.
Obsessive
Compulsive Disorder (OCD) occurs when a person experiences the
following symptoms at the same time:
-
Obsessions
(unwanted, recurrent, and disturbing thoughts)
-
Compulsions
(repetitive, ritualized behaviors that the person feels driven to
perform in order to lessen the anxiety produced by the obsessions)
PTSD
occurs when a person experiences a traumatic event (e.g. assault,
combat experience) and then later feels on edge; avoids situations
that remind them of the event; and experiences flashbacks or
nightmares.
Premenstrual
dysphoric disorder (PMDD) is a condition where a woman experiences
depression, tension, and irritability for a few days prior to
menstruation that end when menstruation begins. These symptoms are
more severe than those of premenstrual syndrome (PMS).
What
is the most important information I should know about Paxil®?
Do
not stop taking paroxetine, even when you feel better. Only your
healthcare provider can determine the length of treatment that is
right for you.
Missing
doses of paroxetine may increase your risk for relapse in your
symptoms.
Stopping
paroxetine abruptly may result in one or more of the following
withdrawal symptoms: irritability, nausea, feeling dizzy, vomiting,
nightmares, headache, and/or paresthesias (prickling, tingling
sensation on the skin).
Depression
is also a part of bipolar illness. People with bipolar disorder who
take antidepressants may be at risk for "switching" from
depression into mania. Symptoms of mania include "high" or
irritable mood, very high self esteem, decreased need for sleep,
pressure to keep talking, racing thoughts, being easily distracted,
frequently involved in activities with a large risk for bad
consequences (for example, excessive buying sprees).
Are
there specific concerns about Paxil® and
pregnancy?
If
you are planning on becoming pregnant, notify your healthcare
provider to best manage your medications. People living with MDD who
wish to become pregnant face important decisions. Untreated MDD has
risks to the fetus, as well as the mother. It is important to
discuss the risks and benefits of treatment with your doctor and
caregivers.
For
mothers who have taken SSRIs during their pregnancy, there appears to
be less than a 1% chance of infants developing persistent pulmonary
hypertension. This is a potentially fatal condition that is
associated with use of the antidepressant in the second half of
pregnancy. However, women who discontinued antidepressant therapy
were five times more likely to have a depression relapse than those
who continued their antidepressant. If you are pregnant, please
discuss the risks and benefits of antidepressant use with your
healthcare provider.
Caution
is advised with breastfeeding since paroxetine
does
pass into breast milk.
What
should I discuss with my healthcare provider before taking Paxil®?
-
Symptoms
of your condition that bother you the most
-
If
you have thoughts of suicide or harming yourself
-
Medications
you have taken in the past for your condition, whether they were
effective or caused any adverse effects
-
If
you experience side effects from your medications, discuss them with
your provider. Some side effects may pass with time, but others may
require changes in the medication.
-
Any
other psychiatric or medical problems you have, including a history
of bipolar disorder
-
All
other medications you are currently taking (including over the
counter products, herbal and nutritional supplements) and any
medication allergies you have
-
Other
non-medication treatment you are receiving, such as talk therapy or
substance abuse treatment. Your provider can explain how these
different treatments work with the medication.
-
If
you are pregnant, plan to become pregnant, or are breast-feeding
-
If
you drink alcohol or use drugs
How
should I take Paxil®?
Paroxetine
is usually taken 1 time per day with or without food.
Typically
patients begin at a low dose of medicine and the dose is increased
slowly over several weeks.
The
dose usually ranges from 10 mg to 40 mg (50 mg for controlled
release). Only
your healthcare provider can determine the correct dose for you.
If
you are taking paroxetine for PMDD, it can be taken once daily
(everyday) or intermittently (usually starting 14 days prior to
menstruation through the first full day of menses of each cycle).
Discuss this with your prescriber.
The
liquid should be measured with a dosing spoon or oral syringe which
you can get from your pharmacy.
The
controlled release form should be swallowed whole. It should not be
chewed, crushed, or broken.
Consider
using a calendar, pillbox, alarm clock, or cell phone alert to help
you remember to take your medication. You may also ask a family
member or friend to remind you or check in with you to be sure you
are taking your medication.
What
happens if I miss a dose of Paxil®?
If
you miss a dose of paroxetine, take it as soon as you remember,
unless it is closer to the time of your next dose. Discuss this with
your healthcare provider. Do not double your next dose or take more
than what is prescribed.
What
should I avoid while taking Paxil®?
Avoid
drinking alcohol or using illegal drugs while you are taking
antidepressant medications.
They may decrease the benefits (e.g., worsen your condition) and
increase adverse effects (e.g., sedation) of the medication.
What
happens if I overdose with Paxil®?
If
an overdose occurs, call your doctor or 911. You may need urgent
medical care. You may also contact the poison control center at
1-800-222-1222.
A
specific treatment to reverse the effects of paroxetine does not
exist.
What
are the possible side effects of Paxil®?
Common
Side Effects
-
Headache,
nausea, diarrhea, dry mouth, increased sweating
-
Feeling
nervous, restless, fatigued, sleepy or having trouble sleeping
(insomnia)
These
will often improve over the first week or two as you continue to take
the medication.
Sexual
side effects, such as problems with orgasm or ejaculatory delay often
do not diminish over time.
Rare
Increased
bleeding (e.g., gums may bleed more easily), low sodium blood levels
(signs of low sodium levels may include headache, weakness,
difficulty concentrating and remembering), teeth grinding
Serious
Side Effects
Seizure
Are
there any risks of taking Paxil® or
long periods of time?
To
date, there are no known problems associated with long term use of
paroxetine. It is a safe and effective medication when used as
directed.
What
other medications may interact with Paxil®?
Paroxetine
should not be taken with or within two weeks of taking monoamine
oxidase inhibitors (MAOIs). These include phenelzine (Nardil®),
tranycypromine (Parnate®),
isocarboxazid (Marplan®),
rasagiline (Azilect®),
and selegeline (Emsam®).
Although
rare, there is an increased risk of serotonin syndrome when
paroxetine is used with other medications that increase serotonin,
such as other antidepressants, migraine medications called “triptans”
(e.g., Imitrex®),
some
pain medications (e.g., tramadol (Ultram®)),
and the antibiotic linezolid (Zyvox®).
Paroxetine
may increase the levels of:
-
Atomoxetine
(Stratterra®)
-
Antipsychotics,
such as aripiprazole (Abilify®),
risperidone (Risperdal®)
-
Warfarin
(Coumadin®)
-
Cardiac
medications such as propafenone (Rythmol®),
metoprolol
(Toprol XL®,
Lopressor®)
and propranolol (Inderal®)
-
Tricyclic
antidepressants, such as, desipramine (Norpramin®),
imipramine (Tofranil®)
Combining
paroxetine with thioridazine (Mellaril®)
is not recommended.
Paroxetine
may increase the effects of other medications that can cause bleeding (e.g.,
ibuprofen (Advil®,
Motrin®),
warfarin (Coumadin®)
and aspirin).
How
long does it take for Paxil® to
work?
Sleep,
energy, or appetite may show some improvement within the first 1-2
weeks. Improvement in these physical symptoms can be an important
early signal that the medication is working. Depressed mood and lack
of interest in activities may need up to 6-8 weeks to fully improve.
Provided
by the College of Psychiatric and Neurologic Pharmacists
(January
2013)
Summary
of Black Box Warnings
Suicidal
Thoughts or Actions in Children and Adults
-
Depression
and certain other psychiatric disorders are themselves associated
with increases in the risk of suicide.
-
Patients
with major depressive disorder (MDD), both adult and pediatric, may
experience worsening of their depression and/or the emergence of
suicidal ideation and behavior (suicidality) or unusual changes in
behavior, whether or not they are taking antidepressant medications.
This risk may persist until significant remission occurs.
-
In
short-term studies, antidepressants increased the risk of
suicidality in children, adolescents, and young adults when compared
to placebo. Short-term studies did not show an increase in the risk of suicidality with antidepressants
compared to placebo in adults beyond age 24. Adults age 65 and
older taking antidepressants have a decreased risk of suicidality.
-
Patients,
their families, and caregivers should be alert to the emergence of
anxiety, restlessness, irritability, aggressiveness and insomnia.
If these symptoms emerge, they should be reported to the patient’s
prescriber or healthcare professional.
-
All
patients being treated with antidepressants for any indication
should watch for and notify their healthcare provider for worsening
symptoms, suicidality and unusual changes in behavior, especially
during the first few months of treatment.
