duloxetine

Pronunciation

Generic Name: duloxetine (du LOX e teen)
Brand Name: Cymbalta

What is duloxetine?

Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Duloxetine affects chemicals in the brain that may become unbalanced and cause depression.

Duloxetine is used to treat major depressive disorder and general anxiety disorder.

Duloxetine is also used to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain).

Duloxetine is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy).

Duloxetine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about duloxetine?

You should not use this medicine if you have untreated or uncontrolled glaucoma, or if you also take thioridazine.

Do not use duloxetine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. After you stop taking duloxetine, you must wait at least 5 days before you start taking an MAOI.

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Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using duloxetine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Do not give this medicine to anyone younger than 18 years old without the advice of a doctor. Duloxetine is not approved for use in children.

What should I discuss with my healthcare provider before taking duloxetine?

You should not use this duloxetine if you are allergic to it, or if you have untreated or uncontrolled glaucoma.

Do not use duloxetine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. After you stop taking duloxetine, you must wait at least 5 days before you start taking an MAOI.

To make sure duloxetine is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • seizures or epilepsy;

  • a bleeding or blood clotting disorder;

  • high blood pressure;

  • narrow-angle glaucoma;

  • bipolar disorder (manic depression); or

  • a history of drug abuse or suicidal thoughts.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using duloxetine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category C. It is not known whether duloxetine will harm an unborn baby. However, duloxetine may cause problems in a newborn if you take the medicine during the third trimester of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of duloxetine on the baby.

Duloxetine can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking this medicine.

Do not give this medicine to anyone younger than 18 years old without the advice of a doctor. Duloxetine is not approved for use in children.

How should I take duloxetine?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Try to take the medicine at the same time each day. Follow the directions on your prescription label.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

It may take 4 weeks or longer before your symptoms improve. Keep using the medication as directed. Do not stop using duloxetine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medicine suddenly.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking duloxetine?

Avoid drinking alcohol. It may increase your risk of liver damage.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with duloxetine may cause you to bruise or bleed easily.

Duloxetine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Duloxetine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

  • easy bruising, unusual bleeding;

  • painful or difficult urination;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

  • low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Older adults may be more sensitive to the side effects of this medicine.

Common side effects may include:

  • vision changes;

  • dry mouth;

  • drowsiness, dizziness;

  • tired feeling;

  • loss of appetite; or

  • increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Duloxetine dosing information

Usual Adult Dose for Depression:

Initial dose: 20 mg orally twice a day
Maintenance dose: 60 mg per day, given either once a day or as 30 mg orally twice a day
Maximum dose: 120 mg orally per day
Duration: Acute episodes generally require several months or more of sustained pharmacological therapy; a periodic review of the need for ongoing maintenance treatment and appropriate dosing is recommended.

Comments:
-Some patients may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day
-Data are lacking to show that doses greater than 60 mg per day confer any additional benefits.

Use: Treatment of major depressive disorder (MDD)

Usual Adult Dose for Fibromyalgia:

Initial dose: 30 mg orally once a day for 1 week
Maintenance dose: 30 to 60 mg orally once a day
Duration: Efficacy has been demonstrated for up to 3 months in placebo-controlled studies; effectiveness beyond this has not been demonstrated in longer studies; therefore, continued treatment should be based on individual patient response.

Comments:
-There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.

Usual Adult Dose for Generalized Anxiety Disorder:

Initial dose: 60 mg orally once a day, increased in increments of 30 mg once a day if clinically appropriate
Maintenance dose: 60 to 120 mg orally once a day
Maximum dose: 120 mg orally once a day
Duration: Episodes generally require several months or more of sustained pharmacological therapy; a periodic review of the need for ongoing maintenance treatment and appropriate dosing is recommended.

Comments:
-Some patients may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day
-Data are lacking to show that doses greater than 60 mg per day confer any additional benefit.
-Maintenance of efficacy has been demonstrated with duloxetine monotherapy.

Usual Adult Dose for Pain:

Initial dose: 30 to 60 mg orally once a day
Maintenance dose: 60 mg orally once a day
Duration:
-Diabetic peripheral neuropathy pain: Efficacy beyond 12 weeks has not been established; effectiveness should be based on individual patient response.
-Chronic musculoskeletal pain: Efficacy beyond 13 weeks has not been established.

Comments:
-Some patients for whom tolerability may be a concern may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day.
-There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.

Uses: Management of neuropathic pain associated with diabetic peripheral neuropathy; management of chronic musculoskeletal pain in patients with chronic low back pain and chronic pain due to osteoarthritis.

What other drugs will affect duloxetine?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking duloxetine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with duloxetine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with duloxetine, especially:

  • any other antidepressant;

  • cimetidine;

  • St. John's wort;

  • theophylline;

  • tryptophan (sometimes called L-tryptophan);

  • an antibiotic--ciprofloxacin, enoxacin;

  • a blood thinner--warfarin, Coumadin, Jantoven;

  • heart rhythm medication--flecainide, propafenone, quinidine, and others;

  • narcotic pain medicine--fentanyl, tramadol;

  • medicine to treat mood disorders, thought disorders, or mental illness--buspirone, lithium, and many others; or

  • migraine headache medicine--sumatriptan, rizatriptan, zolmitriptan, and others.

This list is not complete and many other drugs can interact with duloxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about duloxetine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 10.01. Revision Date: 2014-08-23, 8:13:21 AM.

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