duloxetine

doo-LOX-e-teen

Oral route(Capsule, Delayed Release)

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Duloxetine hydrochloride is not approved for use in pediatric patients .

Commonly used brand name(s)

In the U.S.

• Cymbalta

Available Dosage Forms:

• Capsule


• Capsule, Delayed Release

Therapeutic Class: Antidepressant

Pharmacologic Class: Serotonin/Norepinephrine Reuptake Inhibitor

Uses For duloxetine

Duloxetine is used to treat depression and anxiety. It is also used for pain caused by nerve damage associated with diabetes (diabetic peripheral neuropathy).

Duloxetine is also used to treat fibromyalgia (muscle pain and stiffness) and chronic (long-lasting) pain that is related to muscles and bones.

Duloxetine belongs to a group of medicines known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain.

duloxetine is available only with your doctor's prescription.

Before Using duloxetine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For duloxetine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to duloxetine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of duloxetine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of duloxetine in the elderly. However, elderly patients may be more sensitive to the effects of duloxetine than younger adults, and are more likely to have hyponatremia (low sodium in the blood) which may require caution in patients receiving duloxetine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking duloxetine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using duloxetine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Isocarboxazid


• Linezolid


• Methylene Blue


• Metoclopramide


• Procarbazine


• Rasagiline


• Selegiline


• Thioridazine


• Tranylcypromine

Using duloxetine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Almotriptan


• Anagrelide


• Aspirin


• Cifenline


• Cilostazol


• Citalopram


• Clopidogrel


• Clozapine


• Cyclobenzaprine


• Desvenlafaxine


• Dextromethorphan


• Dipyridamole


• Eletriptan


• Encainide


• Epoprostenol


• Eptifibatide


• Escitalopram


• Flecainide


• Fluoxetine


• Fluvoxamine


• Frovatriptan


• Iloprost


• Indecainide


• Lamifiban


• Lexipafant


• Lithium


• Lorcainide


• Milnacipran


• Naratriptan


• Paroxetine


• Propafenone


• Recainam


• Rizatriptan


• Sertraline


• Sibrafiban


• St John's Wort


• Sulfinpyrazone


• Sulodexide


• Sumatriptan


• Tapentadol


• Ticlopidine


• Tirofiban


• Tramadol


• Trazodone


• Tryptophan


• Venlafaxine


• Vilazodone


• Xemilofiban


• Zolmitriptan

Using duloxetine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac


• Acemetacin


• Acenocoumarol


• Alclofenac


• Benoxaprofen


• Bromfenac


• Bufexamac


• Carprofen


• Celecoxib


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Etodolac


• Etofenamate


• Etoricoxib


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Ibuprofen


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Ketorolac


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Morniflumate


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Parecoxib


• Phenprocoumon


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Propyphenazone


• Proquazone


• Rofecoxib


• Sulindac


• Suprofen


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Valdecoxib


• Warfarin


• Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of duloxetine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or


• Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or


• Kidney disease, severe or


• Liver disease (including cirrhosis) or


• Narrow-angle glaucoma, uncontrolled—Should not be used in patients with these conditions.

• Bleeding problems or


• Diabetes or


• Digestion problems or


• Heart disease or


• Hypertension (high blood pressure) or


• Hyponatremia (low sodium in the blood) or


• Mania, history of or


• Narrow-angle glaucoma, controlled or


• Seizures, history of or


• Urinating problems (e.g., urinary retention or trouble urinating)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of duloxetine

Take duloxetine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

duloxetine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Swallow the delayed-release capsule whole with or without food. Do not chew, crush, or break the capsule. Do not open the capsule and sprinkle the contents on food or in liquids.

You will need to use duloxetine for several weeks before you begin to feel better. Keep using the medicine even if you feel you are not getting better, and talk to your doctor if you have any questions.

Dosing

The dose of duloxetine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of duloxetine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (delayed-release capsules):
  
  • For treatment of anxiety:
    
    • Adults—At first, 60 milligrams (mg) once a day. Some patients may start at 30 mg once a day for one week before increasing the dose to 60 mg once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 120 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For treatment of chronic muscle pain:
    
    • Adults—60 milligrams (mg) once a day. Some patients may start at 30 mg once a day for one week before increasing the dose to 60 mg once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For treatment of depression:
    
    • Adults—40 milligrams (mg) per day (given as 20 mg two times per day) to 60 mg per day (given either once a day or as 30 mg two times per day). Your doctor may increase your dose as needed. However, the dose is usually not more than 120 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For treatment of diabetic peripheral neuropathy:
    
    • Adults—60 milligrams (mg) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For treatment of fibromyalgia:
    
    • Adults—60 milligrams (mg) once a day. Some patients may start at 30 mg once a day for one week before increasing the dose to 60 mg once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of duloxetine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using duloxetine

It is important that your doctor check your progress at regular visits to allow for changes in your dose and to help prevent any unwanted effects.

It is important to tell your doctor if you are pregnant or trying to become pregnant. Your doctor may want you to join a pregnancy registry for patients taking duloxetine.

You will need to have your blood pressure measured before starting duloxetine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Duloxetine has not been shown to add to the effects of alcohol. However, use of alcohol is not recommended in patients who are taking duloxetine.

Duloxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

duloxetine can cause serious liver problems. If you experience symptoms such as dark urine, general tiredness and weakness, light-colored stools, nausea and vomiting, upper right stomach pain, or yellow eyes and skin, contact your doctor right away.

Do not suddenly stop taking duloxetine without checking first with your doctor. If you have been instructed to stop taking duloxetine, ask your doctor how to slowly decrease the dose. This will decrease your chance of having withdrawal symptoms such as dizziness, nausea, headaches, vomiting, increased sweating, irritability, nightmares, or prickling or tingling feelings.

Do not take duloxetine if you have taken an monoamine oxidase (MAO) inhibitor (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. Do not start taking an MAO inhibitor within 5 days of stopping duloxetine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Make sure your doctor knows about all the other medicines you are using. Duloxetine may cause serious conditions called serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions if taken with certain medicines such as linezolid (Zyvox®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, or some pain medicines (e.g., tramadol [Ultram®], sumatriptan [Imitrex®], zolmitriptan [Zomig®], or rizatriptan [Maxalt®]). Check with your doctor first before taking any other medicines.

Serious skin reactions can occur during treatment with duloxetine, including erythema multiforme and Stevens-Johnson Syndrome (SJS). Stop using duloxetine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using duloxetine.

duloxetine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Duloxetine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to duloxetine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly. You may also feel lightheaded when getting up suddenly from a lying or sitting position, so get up slowly. If these symptoms are bothering you or keeping you from doing your daily activities, tell your doctor right away.

duloxetine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal anti-inflammatory agents also called NSAIDs (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®) or warfarin (Coumadin®).

Hyponatremia (low sodium in the blood) may occur with duloxetine. Stop using the medicine and check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

duloxetine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Abdominal or stomach pain


• area rash


• blindness


• blistering, peeling, or loosening of the skin


• blurred vision


• change in consciousness


• chills


• clay-colored stools


• cold sweats


• confusion


• convulsions


• dark urine


• decreased urine output


• decreased vision


• difficulty swallowing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• eye pain


• fainting


• fast or irregular heartbeat


• general tiredness or weakness


• hives or welts


• hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue


• increased thirst


• itching


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• light-colored stools


• loss of consciousness


• red skin lesions, often with a purple center


• red, irritated eyes


• redness of the skin


• shortness of breath


• skin rash


• sores, ulcers, or white spots in the mouth or on the lips


• swelling of the face, ankles, or hands


• tearing


• tightness in the chest


• unpleasant breath odor


• upper right stomach pain


• vomiting of blood


• wheezing


• yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation


• diarrhea


• fever


• loss of bladder control


• muscle spasm or jerking of all extremities


• overactive reflexes


• poor coordination


• restlessness


• shivering


• sleepiness or unusual drowsiness


• sudden loss of consciousness


• sweating


• talking or acting with excitement you cannot control


• trembling or shaking


• twitching


• unusual tiredness or weakness


• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches or pain


• cough


• difficulty having a bowel movement (stool)


• difficulty with breathing


• dry mouth


• ear congestion


• frequent urination


• headache


• lack or loss of strength


• loss of appetite


• loss of voice


• muscle aches


• nausea


• sleepiness or unusual drowsiness


• sleeplessness


• sneezing


• sore throat


• stuffy or runny nose


• sweating increased


• trouble sleeping


• unable to sleep


• weight loss

Less common

• Abnormal orgasm


• acid or sour stomach


• belching


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in taste


• change or problem with discharge of semen


• decreased interest in sexual intercourse


• difficulty with moving


• fear


• feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest


• heartburn


• inability to have or keep an erection


• indigestion


• joint pain


• longer than usual time to ejaculation of semen


• loose stools


• loss in sexual ability, desire, drive, or performance


• loss of taste


• muscle aching or cramping


• muscle pains or stiffness


• nervousness


• shakiness in the legs, arms, hands, or feet


• stomach discomfort, upset, or pain


• sudden sweating


• swollen joints


• trembling or shaking of the hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: duloxetine side effects (in more detail)

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More duloxetine resources

• Duloxetine Side Effects (in more detail)
• Duloxetine Use in Pregnancy & Breastfeeding
• Duloxetine Drug Interactions
• Duloxetine Support Group
• 479 Reviews for Duloxetine - Add your own review/rating

• Cymbalta Consumer Overview


• Cymbalta Prescribing Information (FDA)


• Duloxetine Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Duloxetine Monograph (AHFS DI)

Compare duloxetine with other medications

• Anxiety
• Back Pain
• Bipolar Disorder
• Chronic Fatigue Syndrome
• Depression
• Diabetic Nerve Damage
• Dysthymia
• Fibromyalgia
• Generalized Anxiety Disorder
• Hot Flashes
• Osteoarthritis
• Pain
• Peripheral Neuropathy
• Urinary Incontinence