CYMBALTA DRUG INFO
IMPORTANT NOTE: The following information is intended
to supplement, not substitute for, the expertise and judgment of
your physician, pharmacist or other healthcare professional. It
should not be construed to indicate that use of the drug is
safe, appropriate, or effective for you. Consult your healthcare
professional before using this drug.
DULOXETINE - ORAL (doo lox' e teen)
COMMON BRAND NAME(S): Cymbalta
USES: Duloxetine is used to treat depression and generalized anxiety disorder (GAD;
excessive worry and tension that disrupts daily life and lasts for 6 months or longer).
Duloxetine is also used to treat pain and tingling caused by diabetic neuropathy (damage
to nerves that can develop in people who have diabetes). Duloxetine is in a class of
medications called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs).
It works by increasing the amounts of serotonin and norepinephrine, natural substances
in the brain that help maintain mental balance and stop the movement of pain signals in
the brain.
HOW TO USE: Duloxetine comes as a delayed release (long-acting) capsule to take by
mouth. When duloxetine is used to treat depression, it is usually taken once or twice a
day with or without food. When duloxetine is used to treat generalized anxiety disorder
or the pain of diabetic neuropathy, it is usually taken once a day with or without food.
Take duloxetine at around the same time(s) every day. Follow the directions on your
prescription label carefully, and ask your doctor or pharmacist to explain any part you do
not understand. Take duloxetine exactly as directed. Do not take more or less of it, take
it more often, or take it for a longer time than prescribed by your doctor. Swallow the
capsules whole; do not split, chew, or crush them. Do not open the capsules and mix the
contents with liquids or sprinkle the contents on food. If you are taking duloxetine to
treat generalized anxiety disorder or the pain of diabetic neuropathy, your doctor may
start you on a low dose of medication and gradually increase your dose. Duloxetine may
help control your symptoms but will not cure your condition. It may take 1 to 4 weeks or
longer before you feel the full benefit of duloxetine. Continue to take duloxetine even if
you feel well. Do not stop taking duloxetine without talking to your doctor. Your doctor
will probably decrease your dose gradually. If you suddenly stop taking duloxetine, you
may experience withdrawal symptoms such as dizziness, nausea, vomiting, headache, pain,
burning or tingling in the hands or feet, irritability, and nightmares.Tell your doctor if
you experience any of these symptoms when your dose of duloxetine is decreased.
SIDE EFFECTS: Duloxetine may cause side effects. Tell your doctor if any of these
symptoms are severe or do not go away:
- nausea
- vomiting
- constipation
- diarrhea
- heartburn
- stomach pain
- decreased appetite
- dry mouth
- increased urination
- difficulty urinating
- sweating or night sweats
- dizziness
- headache
- extreme tiredness
- weakness
- muscle pain or cramps
- changes in sexual desire or ability
- uncontrollable shaking of a part of the body
Some side effects can be serious. If you experience any of the following side effects, or
those mentioned in the IMPORTANT WARNING section, call your doctor immediately:
- unusual bruising or bleeding
- pain in the upper right part of the stomach
- itching
- yellowing of the skin or eyes
- dark colored urine
- flu-like symptoms
- blurred vision
- fever
- blisters
- rash
- hives
- swelling of the eyes, face, lips, tongue, throat, hands, arms, feet, ankles, or lower legs
- difficulty breathing or swallowing
Duloxetine may cause other side effects. Call your doctor if you have any
unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a
report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting
program online [at
http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
PRECAUTIONS: Before taking duloxetine,
- tell your doctor and pharmacist if you are allergic to duloxetine or any other medications.
- tell your doctor if you are taking thioridazine or a monoamine oxidase (MAO) inhibitor,
such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar),
and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past
14 days. Your doctor will probably tell you not to take duloxetine. If you stop taking duloxetine,
you should wait at least 5 days before you start to take an MAO inhibitor.
- tell your doctor and pharmacist what other prescription and nonprescription medications,
vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any
of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants
such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine
(Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor),
protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; cimetidine (Tagamet);
diuretics ('water pills'); linezolid (Zyvox); medications for irregular heartbeat such as
amiodarone (Cordarone), flecainide (Tambocor), moricizine (Ethmozine), quinidine (Quinidex) and
propafenone (Rythmol); medications for anxiety, high blood pressure, mental illness, pain, and
nausea; propranolol (Inderal); medications for migraine headaches such as almotriptan (Axert),
eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan
(Imitrex), and zolmitriptan (Zomig); lithium (Eskalith, Lithobid); proton pump inhibitors such as
lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (Aciphex);
quinolone antibiotics such as ciprofloxacin (Cipro) and enoxacin (Penetrex); sedatives; certain
selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem), fluvoxamine
(Luvox) and paroxetine (Paxil); sibutramine (Meridia); sleeping pills; theophylline (Theochron,
Theolair); tramadol (Ultram); and tranquilizers. Many other medications may interact with
duloxetine, so be sure to tell your doctor about all the medications you are taking, even those
that do not appear on this list. Your doctor may need to change the doses of your medications or
monitor you carefully for side effects.
tell your doctor what herbal products you are
taking, especially products containing St. John's wort or tryptophan. tell your doctor if
you have or have ever had glaucoma (an eye condition). Your doctor may tell you that you should
not take duloxetine. tell your doctor if you drink or have ever drunk large amounts of
alcohol or if you use or have ever used street drugs or have ever overused prescription
medications. Also tell your doctor if you have or have ever had a heart attack; high blood
pressure; seizures; coronary artery disease (blockage or narrowing of the blood vessels that lead
to the heart; or heart, liver, or kidney disease. If you have diabetes, be sure to talk to your
doctor about how serious your condition is so your doctor can decide if duloxetine is right for you.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you
become pregnant while taking duloxetine, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are
taking duloxetine.
- you should know that duloxetine may make you drowsy or dizzy. Do not drive a car or operate
machinery until you know how this medication affects you.
- ask your doctor about the safe use of alcoholic beverages while you are taking duloxetine.
Alcohol can increase the risk of serious side effects from duloxetine.
- you should know that duloxetine may cause dizziness, lightheadedness, and fainting when you
get up too quickly from a lying position. This is more common when you first start taking
duloxetine. To avoid this problem, get out of bed slowly, resting your feet on the floor for a
few minutes before standing up.
DRUG INTERACTIONS: Do not take Cymbalta 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 Cymbalta before taking a MAOI.
Serious, and sometimes fatal, reactions have occurred when these medicines have been used
together. Also, do not take Cymbalta if you are taking thioridazine (Mellaril). Dangerous, even
fatal irregular heartbeats may occur if these medicines are taken together. Before taking
Cymbalta, tell your doctor if you are taking any of the following medicines: -an antiarrhythmic
such as flecainide (Tambocor) or propafenone (Rythmol), and others; -a tricyclic antidepressant
such as amitriptyline (Elavil), imipramine (Tofranil), doxepin (Sinequan), nortriptyline
(Pamelor), and others; -venlafaxine (Effexor); -a phenothiazine such as chlorpromazine
(Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon),
prochlorperazine (Compazine), and others; -a quinolone antibiotic such as trovafloxacin
(Trovan), ciprofloxacin (Cipro), ofloxacin (Floxin), and others; -quinidine; or -a selective
serotonin reuptake inhibitor (SSRI) such as fluoxetine (Prozac, Sarafem), paroxetine (Paxil,
Pexeva), fluvoxamine (Luvox), and others.
Cymbalta is in the FDA pregnancy category C. Babies exposed to Cymbalta 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. Cymbalta passes into
breast milk and may affect a nursing infant. Do not take Cymbalta without first talking to your
doctor if you are breast-feeding a baby. Safety and efficacy in pediatric patients have not been
established.
OVERDOSE: Seek emergency medical attention if an overdose is suspected. Symptoms of a
Cymbalta overdose may include nausea, vomiting, tremor, agitation, seizures, drowsiness,
hyperactivity, and enlarged pupils. In case of a missed a dose, take it 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.
NOTES: Do not allow anyone else to take this medication.
MISSED DOSE: Take the missed dose as soon as you remember it. However, if it is almost
time for the next dose, skip the missed dose and continue your regular dosing schedule. Do
not take a double dose to make up for a missed one.
STORAGE: Keep this medication in the container it came in, tightly closed, and out of
reach of children. Store it at room temperature and away from excess heat and moisture (not
in the bathroom).Throw away any medication that is outdated or no longer needed. Talk to your
pharmacist about the proper disposal of your medication.
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