Duloxetine
doo lox’ e teen
IMPORTANT WARNING:
| Studies have shown that children and teenagers who take antidepressants (’mood elevators’) such as duloxetine may be more likely to think about harming or killing themselves or to plan or try to do so than children who do not take antidepressants.Children should not normally take duloxetine.If your child’s doctor has prescribed duloxetine for your child, you should watch his or her behavior and mood very carefully, especially at the beginning of treatment and any time his or her dose is increased or decreased. Your child may develop serious symptoms very suddenly, so it is important to pay attention to his or her behavior or mood every day. Call your child’s doctor right away if he or she experiences any of these symptoms: new or worsening depression; thinking about harming or killing him/herself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling or staying asleep; irritability; aggressive behavior; acting without thinking; severe restlessness; frenzied abnormal excitement, or any other sudden or unusual changes in behavior or mood.Your child’s doctor will want to see your child often while he or she is taking duloxetine, especially at the beginning of his or her treatment. Your child’s doctor may also want to speak with you or your child by telephone from time to time. Be sure that your child keeps all appointments for office visits or telephone conversations with his or her doctor.Your child’s doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when your child begins treatment with duloxetine. Read the information carefully and ask your child’s 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/MG_template.pdf.Talk to your child’s doctor about the risks of giving duloxetine to your child. |
Why is this medication prescribed?
Duloxetine is used to treat depression. 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 should this medicine be used?
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 the pain of diabetic neuropathy, it is usually taken once a day with or without food. To help you remember to take duloxetine, take it around the same time 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 the pain of diabetic neuropathy, your doctor may start you on a low dose of medication and gradually increase your dose.
Duloxetine controls depression and relieves the pain of diabetic neuropathy but does not cure these conditions. It may take 1-4 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, upset stomach, vomiting, headache, pain, burning or tingling in hands or feet, irritability, and nightmares.Tell your doctor if you experience any of these symptoms when your dose of duloxetine is decreased.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking duloxetine,
- tell your doctor and pharmacist if you are allergic to duloxetine or any other medications.
- do not take duloxetine if you are taking monoamine oxidase (MAO) inhibitors, such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate), or if you have stopped taking one of these medications within the past 14 days. 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. 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; chlorpheniramine (found in many cold and allergy medications); cimetidine (Tagamet); codeine; dextromethorphan; diazepam (Valium); dicloxacillin (Dynapen); furosemide (Lasix); haloperidol (Haldol); linezolid (Zyvox); medications for irregular heartbeat such as amiodarone (Cordarone), flecainide (Tambocor), moricizine (Ethmozine), quinidine (Quinidex) and propafenone (Rythmol); medications for anxiety, mental illness, pain, seizures, and upset stomach; methadone (Dolophine); ondansetron (Zofran);propranolol (Inderal); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); proton pump inhibitors such as lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (Aciphex); quinolone antibiotics such as ciprofloxacin (Cipro), enoxacin (Penetrex) gatifloxacin (Tequin), gemifloxacin (Factive), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin) and sparfloxacin (Zagam); ritonavir (Norvir); sedatives; selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox) and paroxetine (Paxil); risperidone (Risperdal); sleeping pills; tamoxifen (Nolvadex); thioridazine (Mellaril); tramadol (Ultram); ticlopidine (Ticlid); tranquilizers, and venlafaxine (Effexor). 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 or anyone in your family has or ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), or if you or anyone in your family has thought about or attempted suicide. Also tell your doctor if you drink or have ever drunk large amounts of alcohol; use or have ever used street drugs or have ever overused prescription medications; if you have recently had a heart attack or serious injury to any part of your body; and if you have or have ever had glaucoma (an eye disease); problems urinating; high blood pressure; seizures; 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. 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 your mental health may change in unexpected ways, especially at the beginning of your treatment and any time that your dose is increased or decreased. These changes may occur at any time if you have depression or another mental illness, whether or not you are taking duloxetine or any other medication. These changes may also occur while you are taking duloxetine to treat the pain of diabetic neuropathy. You, your family, or your 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 knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
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 this medication cause?
Duloxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- upset stomach
- vomiting
- constipation
- diarrhea
- heartburn
- decreased appetite
- dry mouth
- cough
- sweating or night sweats
- blurred vision
- dizziness
- extreme tiredness
- weakness
- muscle pain or cramps
- changes in sexual desire or ability
- runny nose
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:
- shaking hands that you cannot control
- rash
- difficult, painful, or very frequent urination
- fever, sore throat, chills, or other signs of infection
- 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
Duloxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What storage conditions are needed for this medicine?
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.
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.
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.
Brand names
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Last Revised - 01/01/2007