Cymbalta® (duloxetine)
Brand
name:
Cymbalta®
Generic
name: duloxetine (doo
LOX e teen)
Medication
class: Serotonin-norepinephrine reuptake inhibitor (SNRI)
antidepressant
All FDA black box
warnings are at the end of this fact sheet. Please review
before taking this medication.
What
is Cymbalta® and
what does it treat?
Duloxetine
is an antidepressant medication that works in the brain. It is
approved for the treatment of major depressive disorder (MDD),
generalized anxiety disorder (GAD), diabetic peripheral neuropathic
pain (DPNP), fibromyalgia, and chronic musculoskeletal pain.
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)
What
is the most important information I should know about Cymbalta®?
Do
not stop taking duloxetine, even when you feel better. Only your
healthcare provider can determine the length of treatment that is
right for you.
Missing
doses of duloxetine may increase your risk for relapse in your
symptoms.
Stopping
duloxetine 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 Cymbalta® 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.
Caution
is advised with breastfeeding since duloxetine does
pass into breast milk.
What
should I discuss with my healthcare provider before taking Cymbalta®?
-
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, kidney or liver disease
-
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 Cymbalta®?
Duloxetine
is usually taken 1 or 2 times 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 20 mg to 120 mg. Only
your healthcare provider can determine the correct dose for you.
The
capsule 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 Cymbalta®?
If
you miss a dose of duloxetine 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 Cymbalta®?
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. Alcohol
increases the risk of liver problems with duloxetine.
What
happens if I overdose with Cymbalta®?
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 duloxetine does not
exist.
What
are the possible side effects of Cymbalta®?
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.
These
often do not improve over time.
Rare
Side Effects
Increased
heart rate, low blood pressure, increased salivation, irregular
menstrual cycle, increased frequency of urination, changes in taste,
increased liver enzymes, increased bleeding (e.g., gums may bleed
more easily), low sodium (signs
of low sodium levels may include headache, weakness, difficulty
concentrating and remembering),
teeth grinding, difficulty urinating
Serious
Side Effects
Hypertensive
crisis (severely elevated blood pressure), myocardial infarction
(heart attack), Stevens-Johnson syndrome (rash), serotonin syndrome,
and gastrointestinal hemorrhage (bleeding from the gastrointestinal
tract)
Are
there any risks of taking Cymbalta® for long periods of time?
To
date, there are no known problems associated with long term use of
duloxetine. It is a safe and effective medication when used as
directed.
What
other medications may interact with Cymbalta®?
Duloxetine
should not be taken with or within 2 weeks of taking monoamine
oxidase inhibitors (MAOIs). These include phenelzine (Nardil®),
tranylcypromine (Parnate®),
isocarboxazid (Marplan®),
rasagiline (Azalect®)
and selegeline (Emsam®).
Although
rare, there is an increased risk of serotonin syndrome when
duloxetine 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®).
Duloxetine
may increase the effects of other medications that can cause bleeding (e.g.,
ibuprofen (Advil®, Motrin®), warfarin (Coumadin®) and aspirin).
The
following medications may increase the levels and effects of duloxetine: cimetidine (Tagamet®),
ciprofloxacin (Cipro®), fluoxetine (Prozac®), fluvoxamine (Luvox®),
paroxetine (Paxil®)
How
long does it take for Cymbalta® 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.
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