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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?

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

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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.

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

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

Do not use this medication if you are allergic to duloxetine, or if you have untreated or uncontrolled glaucoma.

Do not use duloxetine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. 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;

  • glaucoma;

  • bipolar disorder (manic depression);

  • a history of drug abuse or suicidal thoughts; or

  • if you are being treated with methylene blue injection.

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 medication.

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 medication.

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

Do not give this medicine to a child without medical advice.

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 medication 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.

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:

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

  • feeling like you might pass out;

  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, vomiting, diarrhea, loss of coordination;

  • very stiff (rigid) muscles, high fever, sweating, confusion, tremors;

  • easy bruising, unusual bleeding;

  • painful or difficult urination;

  • headache, trouble concentrating, memory problems, weakness, feeling unsteady, seizure, shallow breathing or breathing that stops; 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.

Other common side effects may include:

  • dry mouth;

  • drowsiness;

  • tired feeling;

  • mild nausea or loss of appetite; or

  • constipation.

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 Pain:

For use in the management of neuropathic pain associated with diabetic peripheral neuropathy and for the management of chronic musculoskeletal pain in patients with chronic low back pain and chronic pain due to osteoarthritis:

Usual Dose: 60 mg once a day without regard to meals.

For patients in whom tolerability is a concern, a lower starting dose may be considered.

Although a 120 mg per day dose was shown to be safe and effective, there is no evidence that doses higher than 60 mg have any additional benefit. Furthermore, the higher dose has been clearly less well tolerated.

Efficacy beyond 12 weeks has not been systematically studied in placebo-controlled studies, but a one year open label safety study has been conducted.

Usual Adult Dose for Depression:

Initial Dose: 40 mg per day (administered as 20 mg twice daily) to 60 mg per day (given either once a day or as 30 mg twice daily) without regard to meals.

Usual Adult Dose for Anxiety:

Initial dose: 60 mg orally once a day If necessary, dosage may be increased in increments of no more than 30 mg per day Maximum dose: 120 mg per day For patients in whom tolerability is a concern, a lower an initial dose of 30 mg orally once a day may be considered. Following one week of therapy, the dose may be increased to 60 mg orally once a day in this patient population. Although a 120 mg per day dose was shown to be safe and effective, there is no evidence that doses higher than 60 mg have any additional benefit.

It is generally agreed that episodes of generalized anxiety disorder require several months or longer of sustained pharmacological therapy. Maintenance of efficacy in generalized anxiety disorder has been demonstrated with duloxetine as monotherapy. Duloxetine should be administered in a dose range of 60 to 120 mg once daily. Patients should be periodically reassessed to determine the continued need for maintenance treatment and the appropriate dose for such treatment.

Usual Adult Dose for Fibromyalgia:

Initial Dose: 30 mg once a day without regard to meals for one week.

Usual Dose: 60 mg once a day without regard to meals.

Treatment should begin at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. Some patients may respond to the starting dose. There is no evidence that doses greater than 60 mg/day confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions.

Fibromyalgia is recognized as a chronic condition. The efficacy of duloxetine in the management of fibromyalgia has been demonstrated in placebo-controlled studies up to three months. The efficacy of duloxetine was not demonstrated in longer studies; however, continued treatment should be based on individual patient response.

What other drugs will affect duloxetine?

Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen, naproxen, celecoxib, diclofenac, indomethacin, piroxicam, nabumetone, etodolac, and others. Taking any of these drugs with duloxetine may cause you to bruise or bleed easily.

Taking duloxetine with other drugs that make you sleepy or slow your breathing can increase these effects. 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:

  • a blood thinner such as warfarin, Coumadin;

  • buspirone;

  • cimetidine;

  • a diuretic or "water pill";

  • fentanyl;

  • lithium;

  • St. John's wort;

  • tramadol;

  • tryptophan (sometimes called L-tryptophan);

  • an antibiotic such as ciprofloxacin;

  • almotriptan, frovatriptan, sumatriptan, naratriptan, rizatriptan, or zolmitriptan; or

  • any other antidepressant such as desipramine, fluoxetine, fluvoxamine, paroxetine, 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: 9.03. Revision Date: 2012-12-13, 3:15:42 PM.

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