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What is the most important information I should know about
duloxetine?
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While you are taking duloxetine you may need to be monitored for
worsening symptoms of depression and/ or suicidal thoughts at the start
of therapy or when doses are changed. This concern about the increased
risk of suicidal thoughts or behaviors may be greater if you are 18
years of age or younger and are taking duloxetine. In patients younger
than 18 years, the period of risk may extend beyond start of therapy or
when doses are changed. Your doctor may want you to monitor for the
following symptoms: anxiety, panic attacks, difficulty sleeping,
irritability, hostility, impulsivity, severe restlessness, and mania (mental
and/ or physical hyperactivity). These symptoms may be associated with
the development of worsening symptoms of depression and/ or suicidal
thoughts or actions. Contact your healthcare provider if you develop any
new or worsening mental health symptoms during treatment with duloxetine.
Do not stop taking duloxetine. |
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Duloxetine may cause liver injury. Talk to your doctor before taking
duloxetine if you have or have had liver problems or drink alcohol
regularly. |
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Avoid alcohol during treatment with duloxetine. Together, alcohol
and duloxetine can be damaging to the liver. |
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Do not stop taking duloxetine without first talking to your doctor.
It may take several weeks before you start feeling better. |
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Duloxetine is an antidepressant medication. It affects chemicals in
the brain that may become unbalanced and cause depression. |
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Duloxetine is used to treat major depressive disorder (MDD) and for
the management of pain associated with diabetic peripheral neuropathy. |
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Duloxetine may also be used for purposes other than those listed in
this medication guide. |
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What should I discuss with my healthcare provider before taking
duloxetine?
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• |
While you are taking duloxetine you may need to be monitored for
worsening symptoms of depression and/ or suicidal thoughts at the start
of therapy or when doses are changed. This concern about the increased
risk of suicidal thoughts or behaviors may be greater if you are 18
years of age or younger and are taking duloxetine. In patients younger
than 18 years, the period of risk may extend beyond start of therapy or
when doses are changed. Your doctor may want you to monitor for the
following symptoms: anxiety, panic attacks, difficulty sleeping,
irritability, hostility, impulsivity, severe restlessness, and mania (mental
and/ or physical hyperactivity). These symptoms may be associated with
the development of worsening symptoms of depression and/ or suicidal
thoughts or actions. Contact your healthcare provider if you develop any
new or worsening mental health symptoms during treatment with duloxetine.
Do not stop taking duloxetine. |
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Do not take duloxetine if you have taken a monoamine oxidase
inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil),
or tranylcypromine (Parnate) during the last 2 weeks. Wait at least 5
days after you stop taking duloxetine before taking a MAOI. Serious, and
sometimes fatal, reactions have occurred when these medicines have been
used together. Also, do not take duloxetine if you are taking
thioridazine (Mellaril). Dangerous, even fatal irregular heartbeats may
occur if these medicines are taken together. You must wait 5 weeks after
stopping duloxetine before taking thioridazine (Mellaril). |
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Duloxetine may cause liver injury. Talk to your doctor before taking
duloxetine if you have or have had liver problems or drink alcohol
regularly. |
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Tell your doctor about any medications you have been taking, even if
you have stopped taking them, before you take duloxetine. |
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Talk to your doctor before taking any other medications after you
stop taking duloxetine. |
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Before taking duloxetine, tell your doctor if you |
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drink alcohol regularly; |
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have high blood pressure; |
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suffer from seizures; or |
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suffer from mania or have suicidal thoughts. |
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You may not be able to take duloxetine, or you may need a dosage
adjustment or special monitoring during treatment if you have any of the
conditions listed above. |
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Duloxetine is in the FDA pregnancy category C. Babies exposed to
duloxetine and/ or other drugs of the same class during the third
trimester of pregnancy may develop medical complications. Discuss the
risks with your doctor. Do not take this medication without first
talking to your doctor if you are pregnant or could become pregnant
during treatment. |
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Duloxetine passes into breast milk and may affect a nursing infant.
Do not take duloxetine without first talking to your doctor if you are
breast-feeding a baby. |
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How should I take duloxetine?
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Take duloxetine exactly as directed by your doctor. If you do not
understand these instructions, ask your pharmacist, nurse, or doctor to
explain them to you. |
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Take each dose with water. |
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Duloxetine capsules should be swallowed whole and should not be
chewed or crushed, nor should the contents be sprinkled on food or mixed
with liquids. |
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Duloxetine may be taken with or without food. |
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Try to take duloxetine at the same time each day. |
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Do not stop taking duloxetine without first talking to your doctor.
It may take several weeks before you start feeling better. |
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It is important to take duloxetine regularly to get the most benefit. |
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Your doctor may want to perform tests or schedule appointments to
monitor your treatment with duloxetine. |
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Store duloxetine at room temperature away from moisture and heat. |
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What happens if I miss a dose?
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Take the missed dose as soon as you remember. However, if it is
almost time for the next regularly scheduled dose, skip the missed dose
and take the next one as directed. Do not take a double dose of
this medication unless otherwise directed by your doctor. |
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What happens if I overdose?
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Seek emergency medical attention if an overdose is suspected. |
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Symptoms of a duloxetine overdose may include nausea, vomiting,
tremor, agitation, seizures, drowsiness, hyperactivity, and enlarged
pupils. |
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What should I avoid while taking duloxetine?
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Use caution when driving, operating machinery, or performing other
hazardous activities. Duloxetine may cause dizziness or drowsiness. If
you experience dizziness or drowsiness, avoid these activities. |
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Avoid alcohol during treatment with duloxetine. Together, alcohol
and duloxetine can be damaging to the liver. |
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What are the possible side effects of duloxetine?
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If you experience any of the following serious side effects, stop
taking duloxetine and contact your doctor immediately or seek emergency
medical treatment: |
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an allergic reaction (difficulty breathing; closing of the throat;
swelling of the lips, tongue, or face; or hives); |
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an irregular heartbeat or pulse; |
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low
blood pressure (dizziness, weakness); |
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high blood pressure (severe headache, blurred vision); |
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unusual bleeding or bruising; |
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If you experience any of the following less serious side effects,
continue taking duloxetine and talk to your doctor: |
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headache, tremor, nervousness, or anxiety; |
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difficulty concentrating; |
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nausea, diarrhea, dry mouth, or changes in appetite or weight; |
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sleepiness or insomnia; or |
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decreased sex drive, impotence, or difficulty having an orgasm. |
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Side effects other than those listed here may also occur. Talk to
your doctor about any side effect that seems unusual or that is
especially bothersome. |
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What other drugs will affect duloxetine?
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Do not take duloxetine if you have taken a monoamine oxidase
inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil),
or tranylcypromine (Parnate) during the last 2 weeks. Wait at least 5
days after you stop taking duloxetine before taking a MAOI. Serious, and
sometimes fatal, reactions have occurred when these medicines have been
used together. Also, do not take duloxetine if you are taking
thioridazine (Mellaril). Dangerous, even fatal irregular heartbeats may
occur if these medicines are taken together. You must wait 5 weeks after
stopping duloxetine before taking thioridazine (Mellaril). |
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Before taking duloxetine, tell your doctor if you are taking any of
the following medicines: |
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an antiarrhythmic such as flecainide (Tambocor) or propafenone (Rythmol),
and others; |
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a tricyclic antidepressant such as amitriptyline (Elavil),
imipramine (Tofranil), doxepin (Sinequan), nortriptyline (Pamelor), and
others; |
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a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Prolixin),
mesoridazine (Serentil), perphenazine (Trilafon), prochlorperazine (Compazine),
and others; |
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a quinolone antibiotic such as trovafloxacin (Trovan), ciprofloxacin
(Cipro), ofloxacin (Floxin), and others; |
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a selective serotonin reuptake inhibitor (SSRI) such as fluoxetine (Prozac,
Sarafem), paroxetine (Paxil, Pexeva), fluvoxamine (Luvox), and others. |
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You may not be able to take duloxetine, or you may require a dosage
adjustment or special monitoring during treatment if you are taking any
of the medicines listed above. |
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Drugs other than those listed here may also interact with duloxetine.
Talk to your doctor and pharmacist before taking any prescription or
over-the-counter medicines, including vitamins, minerals, and herbal
products. |
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Where can I get more information?
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Your pharmacist has additional information about duloxetine written
for health professionals that you may read. |
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Remember, keep this and all other medicines out of the reach of
children, never share your medicines with others, and use this
medication only for the indication prescribed. |
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Every effort has been made to ensure that the information provided
by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete,
but no guarantee is made to that effect. Drug information contained
herein may be time sensitive. Multum information has been compiled for
use by healthcare practitioners and consumers in the United States and
therefore Multum does not warrant that uses outside of the United States
are appropriate, unless specifically indicated otherwise. Multum's drug
information does not endorse drugs, diagnose patients or recommend
therapy. Multum's drug information is an informational resource designed
to assist licensed healthcare practitioners in caring for their patients
and/ or to serve consumers viewing this service as a supplement to, and
not a substitute for, the expertise, skill, knowledge and judgment of
healthcare practitioners. The absence of a warning for a given drug or
drug combination in no way should be construed to indicate that the drug
or drug combination is safe, effective or appropriate for any given
patient. Multum does not assume any responsibility for any aspect of
healthcare administered with the aid of information Multum provides. The
information contained herein is not intended to cover all possible uses,
directions, precautions, warnings, drug interactions, allergic reactions,
or adverse effects. If you have questions about the drugs you are taking,
check with your doctor, nurse or pharmacist. |
Copyright 1996-2005 Cerner Multum, Inc. Version: 2.01. Revision date: 10/
19/ 05. |