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(Duloxetine)

Duloxetine (Generic Cymbalta) is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat depression and generalized anxiety disorder. It may also be used to treat certain types of nerve pain and other conditions as determined by your doctor.
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Cymbalta

GENERIC NAME: Duloxetine
BRAND NAME: Cymbalta

IMPORTANT WARNING:
A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as Cymbalta during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take Cymbalta, but in some cases, a doctor may decide that Cymbalta is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take Cymbalta or other antidepressants even if you are an adult over age 24. These changes may occur even if you do not have a mental illness and you are taking Cymbalta to treat a different type of condition. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking Cymbalta, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with Cymbalta. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/cder/drug/antidepressants/antidepressants_MG_2007.pdf.

No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Why is Cymbalta prescribed?
Cymbalta 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). Cymbalta is also used to treat pain and tingling caused by diabetic neuropathy (damage to nerves that can develop in people who have diabetes). Cymbalta 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 should Cymbalta be used?
Cymbalta comes as a delayed release (long-acting) capsule to take by mouth. When Cymbalta is used to treat depression, it is usually taken once or twice a day with or without food. When Cymbalta 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 Cymbalta 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 Cymbalta 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 Cymbalta 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.

Cymbalta 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 Cymbalta. Continue to take Cymbalta even if you feel well. Do not stop taking Cymbalta without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking Cymbalta, 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 Cymbalta is decreased.

Other uses for Cymbalta
Cymbalta is also sometimes used to treat stress urinary incontinence (leakage of urine during physical activity such as coughing, sneezing, laughing, and exercise) in women. Talk to your doctor about using Cymbalta to treat your condition.

Cymbalta may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?
Before taking Cymbalta,

tell your doctor and pharmacist if you are allergic to Cymbalta 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 Cymbalta. If you stop taking Cymbalta, 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 Cymbalta, 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 Cymbalta.
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 Cymbalta 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 Cymbalta, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Cymbalta.
you should know that Cymbalta may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how Cymbalta affects you.
ask your doctor about the safe use of alcoholic beverages while you are taking Cymbalta..Alcohol can increase the risk of serious side effects from Cymbalta.
you should know that Cymbalta 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 Cymbalta. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a 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.

What side effects can Cymbalta cause?
Cymbalta 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

Cymbalta may cause other side effects. Call your doctor if you have any unusual problems while taking Cymbalta.

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].

What storage conditions are needed for Cymbalta?
Keep Cymbalta in the container it came in, tightly closed, and out of reach of children. Store Cymbalta 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.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

agitation
hallucinating (seeing things or hearing voices that do not exist)
fast heartbeat
fever
loss of coordination
nausea
vomiting
diarrhea
drowsiness
seizures

What other information should I know?
Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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