Duloxetine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat anxiety, depression, fibromyalgia, or diabetic neuropathy. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: selective serotonin and norepinephrine reuptake inhibitor (SNRI) antidepressant

Generic and brand names: duloxetine, oral; Cymbalta; Irenka

What is this medicine used for?

This medicine is taken by mouth to treat:

• Major depressive disorder
• Generalized anxiety disorder
• Fibromyalgia
• Chronic muscle and bone pain
• Diabetic peripheral neuropathy (pain from damage of the nerves in people with diabetes)

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Bleeding problems
• Blood pressure problems
• Delayed stomach emptying
• Diabetes
• Glaucoma
• Heart disease or a heart attack
• Kidney or liver disease
• Mental health problems such as bipolar disorder or thoughts of suicide
• Problems with alcohol or drug abuse
• Problems with low levels of sodium in your blood
• Seizures

Do not take this medicine if you have taken an MAO inhibitor in the last 2 weeks. Also, do not start taking an MAO inhibitor within 5 days after stopping this medicine. Talk with your healthcare provider about this.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or take it longer than prescribed.

Check with your healthcare provider before using this medicine in children under age 7.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Swallow the capsules whole. Do not crush, chew, or mix the medicine in food or a liquid.

You may need to take this medicine for a long time. If you need to take this medicine for more than a few days, do not stop taking it suddenly. You may have to reduce your dosage gradually to avoid serious side effects. Follow your healthcare provider's instructions.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, diarrhea, drowsiness, restlessness, confusion, hallucinations, fast heartbeat, lightheadedness, fainting, seizures, coma.

What should I watch out for?

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment or at times of dose changes. Talk with your healthcare provider about this.

Behavior changes may be caused by the medicine or by depression or another mental health problem. Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

• More outgoing or aggressive behavior than normal
• Confusion
• Hallucinations
• Worsening of depression
• Suicidal thoughts

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination
• Tremor
• Stiff muscles
• Fast heart beat
• Rapid changes in blood pressure
• Increased body temperature, sweating, or flushing
• Dizziness
• Nausea
• Vomiting
• Diarrhea

This medicine may cause a severe skin reaction. If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

You may need to have blood tests and blood pressure checks regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may trigger angle-closure glaucoma. Contact your provider right away if you have eye pain, vision changes, or redness and swelling in or around your eye.

This medicine may cause liver problems or increase the risk of bleeding problems. Talk with your healthcare provider about this.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. Also, drinking alcohol may make it worse. This medicine increases the effects of alcohol and other medicines. Do not drink alcohol or take other medicines, including nonprescription products or natural remedies, unless your healthcare provider approves.

This medicine may cause blurred vision and dizziness. Do not drive or operate machinery until you are fully alert and can see clearly.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: this medicine may affect blood sugar test results. Talk to your healthcare provider before you change your dosage of diabetes medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Seizures; chest pain; irregular or fast heartbeat; severe dizziness or lightheadedness; vision changes; fainting; unusual nervousness, restlessness, or irritability; hallucinations; confusion; stiff muscles, tremors, loss of coordination or unsteadiness; fever; panic attacks; severe or ongoing trouble sleeping; worsening depression or thoughts of suicide; skin blisters, peeling rash, or sores in the mouth; yellowing of your skin or eyes; dark urine; itching; light colored bowel movements; severe nausea, vomiting, or diarrhea; unusual tiredness or weakness; black tarry bowel movement; unusual bruising or bleeding; memory problems or trouble concentrating; trouble urinating or decreased urination.

Other: Nausea, vomiting, gas, constipation, dry mouth, loss of appetite, weight changes, change in sexual ability or desire, stomach pain, headache, drowsiness, increased sweating, mild dizziness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alpha blockers such as doxazosin (Cardura) and prazosin (Minipress)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as ciprofloxacin (Cipro), isoniazid, levofloxacin (Levaquin), linezolid (Zyvox), and ofloxacin
• Antidepressants such as amitriptyline, desipramine (Norpramin), desvenlafaxine (Pristiq), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), venlafaxine (Effexor), and vilazodone (Viibryd)
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), perphenazine, pimozide (Orap), thioridazine, thiothixene (Navane), and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, and primidone (Mysoline)
• Atomoxetine (Strattera)
• Beta blockers such as carvedilol (Coreg), metoprolol (Lopressor, Toprol), nebivolol (Bystolic), and timolol
• Blood pressure medicines such as hydralazine, methyldopa, minoxidil, and reserpine
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Buspirone
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), nilotinib (Tasigna), tamoxifen, and vemurafenib (Zelboraf)
• Cimetidine (Tagamet)
• Cough, cold, or allergy medicines such as chlorpheniramine (Chlor-Trimeton), dextromethorphan, and diphenhydramine (Benadryl)
• Dextromethorphan/quinidine (Nuedexta)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Gemfibrozil (Lopid)
• Heart medicines such as amiodarone (Cordarone, Pacerone), dronedarone (Multaq), flecainide, mexiletine, propafenone (Rythmol), and quinidine
• HIV medicines such as darunavir (Prezista), delavirdine (Rescriptor), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and tipranavir (Aptivus)
• Ketoconazole (Nizoral)
• Lithium (Lithobid)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not start taking this medicine if you have taken an MAO inhibitor in the last 14 days; Do not start an MAO inhibitor within 5 days after stopping this medicine.)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), aspirin, bivalirudin (Angiomax), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), heparin, prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Methoxsalen (8-MOP, Oxsoralen Ultra, Uvadex)
• Metoclopramide (Metozolv, Reglan)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as alfalfa, anise, bilberry, cat's claw, garlic, ginger, ginkgo biloba, ginseng, glucosamine, gotu kola, kava, SAMe, St. John's wort, tryptophan, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Pain medicines such as buprenorphine (Buprenex, Butrans), codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sleeping pills such as butabarbital (Butisol), ramelteon (Rozerem), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants and diet pills such as dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and methylphenidate (Concerta, Daytrana, Metadate, Ritalin)
• Terbinafine (Lamisil)
• Theophylline

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.