Duloxetine

doo-LOX-e-teen

Oral routeCapsule, Delayed Release
  • Suicidality and Antidepressant Drugs
    • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of duloxetine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed 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 .

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. 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 mental depression and generalized anxiety disorder. It is also used for pain caused by nerve damage associated with diabetes.

Duloxetine is also used to treat a condition called fibromyalgia (muscle pain and stiffness).

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 CategoryExplanation
All TrimestersCAnimal 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

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
  • 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
  • Acenocoumarol
  • Almotriptan
  • Anagrelide
  • Ancrod
  • Anisindione
  • Antithrombin III Human
  • Ardeparin
  • Aspirin
  • Bivalirudin
  • Certoparin
  • Cifenline
  • Cilostazol
  • Citalopram
  • Clopidogrel
  • Cyclobenzaprine
  • Dalteparin
  • Danaparoid
  • Defibrotide
  • Dermatan Sulfate
  • Desirudin
  • Desvenlafaxine
  • Dicumarol
  • Dipyridamole
  • Eletriptan
  • Encainide
  • Enoxaparin
  • Epoprostenol
  • Eptifibatide
  • Escitalopram
  • Flecainide
  • Fluoxetine
  • Fluvoxamine
  • Fondaparinux
  • Frovatriptan
  • Heparin
  • Iloprost
  • Indecainide
  • Lamifiban
  • Lexipafant
  • Lithium
  • Lorcainide
  • Milnacipran
  • Nadroparin
  • Naratriptan
  • Parnaparin
  • Paroxetine
  • Pentosan Polysulfate Sodium
  • Phenindione
  • Phenprocoumon
  • Propafenone
  • Rasagiline
  • Recainam
  • Reviparin
  • Rizatriptan
  • Sertraline
  • Sibrafiban
  • St John's Wort
  • Sulfinpyrazone
  • Sulodexide
  • Sumatriptan
  • Tapentadol
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tramadol
  • Tryptophan
  • Venlafaxine
  • Warfarin
  • 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
  • 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
  • Phenylbutazone
  • Pirazolac
  • Piroxicam
  • Pirprofen
  • Propyphenazone
  • Proquazone
  • Rofecoxib
  • Sulindac
  • Suprofen
  • Tenidap
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolmetin
  • Valdecoxib
  • 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:

  • Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or
  • Kidney disease, severe or
  • Liver disease 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—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. Read and follow the instructions in the guide carefully. Talk with your doctor or pharmacist if you have any questions.

Swallow the delayed-release capsule whole. Do not chew, crush, or open the capsule and sprinkle the contents on food or mix with liquids before swallowing. You may take the delayed-release capsule with or without food.

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 depression:
      • Adults—40 milligrams (mg) a day (given as 20 mg two times a day) to 60 mg a day (given either once a day or as 30 mg two times a day). Your doctor may increase your dose as needed. However, the dose is usually not more than 120 mg 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 milligrams (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 generalized anxiety disorder:
      • 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 usually is not more than 120 mg a day.
      • Children—Use and dose must be determined by your doctor.
    • For treatment of pain associated with diabetic peripheral neuropathy:
      • Adults—60 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
      • 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 reduce any side effects.

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 people 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. If you, your child, or your caregiver notice any of these adverse effects, tell your doctor or your child's doctor right away.

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 abdominal pain, or yellow eyes and skin, contact your doctor immediately.

Four weeks of duloxetine may be required before your symptoms improve. It is important to continue duloxetine after symptoms of depression are relieved.

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 is to decrease the chance of having discontinuation symptoms such as dizziness, nausea, headache, vomiting, 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 such as serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines such as linezolid [Zyvox®], lithium, 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.

For diabetic patients:

  • duloxetine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, 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 from a lying or sitting position suddenly, so get up slowly. If these symptoms are bothering you or keeping you from doing your daily activities, tell your doctor right away.

Make sure your doctor knows if you are also using aspirin, NSAIDS (e.g., aspirin, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®) or a blood thinner (e.g., warfarin, Coumadin®). Duloxetine may increase your risk of having bleeding problems especially when taken together with these medicines.

Since smoking may decrease the treatment effects of duloxetine, it is best to avoid smoking while you are using it. If you have any questions about this, check with your doctor.

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 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, irritated eyes
  • red skin lesions, often with a purple center
  • 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 abdominal 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 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.

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