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Duloxetine

Brand name

• Cymbalta®
  • Capsules (delayed release): 30 mg, 60 mg, 90 mg

Generic name

• Duloxetine

What is Cymbalta® and what does it treat?

Duloxetine is an antidepressant medication that works in the brain. It is approved for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), and fibromyalgia. Major depression occurs when a person experiences several of the following symptoms concurrently, for at least two weeks: "low" or depressed mood (for example, sad, empty, tearful), decreased interest in most or all activities, changes in appetite (usually decreased), changes in sleep (usually poor sleep), loss of energy, feeling worthless/guilty/hopeless/helpless, psychomotor agitation or retardation (i.e., thoughts/movements speeding up or slowing down), difficulty concentrating, and thoughts of death (suicidal thinking).

GAD occurs when a person experiences excessive anxiety or worry for at least six months along with restlessness, fatigue, difficulty concentrating, irritability, muscle tension or sleep disturbance.

What is the most important information I should know about Cymbalta®?

After starting duloxetine, symptoms gradually decrease over a period of weeks. Sleep and other physical symptoms may improve before there is noticeable improvement in mood or interest in activities. Once symptoms are under control, MDD and anxiety disorders usually require long-term treatment to help prevent the return of symptoms. Only your healthcare provider can determine the length of duloxetine treatment that is right for you.

Do not stop taking duloxetine or change your dose without talking to with your healthcare provider first.

Stopping duloxetine abruptly may result in one or more of the following withdrawal symptoms: irritability, nausea, dizziness, vomiting, nightmares, headache and paresthesias (prickling, tingling sensation on the skin).

It is recommended that duloxetine should not be used in patients with any liver impairment.

Depression is also a part of bipolar illness. People with bipolar disorder who take antidepressants may be at risk for "switching" from depression into mania. Symptoms of mania include "high" or irritable mood, very high self esteem, decreased need for sleep, pressure to keep talking, racing thoughts, being easily distracted, frequently involved in activities with a large risk for bad consequences (for example, excessive buying sprees).

Are there specific concerns about Cymbalta® and pregnancy?

If you are planning on becoming pregnant, notify your healthcare provider so that he/she can best manage your medications. People living with MDD and anxiety who wish to become pregnant face important decisions, each with risks and benefits as it relates to how the illness, medications and the risks to the fetus may interact. This is a complex decision as untreated MDD and anxiety have risks to the fetus as well as the mother. There are many dimensions to these choices, so be sure to confer with your doctor and caregivers.

Regarding breast-feeding, caution is advised since duloxetine does pass into breast milk.

What should I discuss with my healthcare provider before taking Cymbalta®?

• The most bothersome symptoms of your condition
• If you have thoughts of suicide
• Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects
• If you experience side effects from your medications, discuss them with your provider. Some side effects may pass with time, but others may require an adjustment in the medication.
• Any other psychiatric or medical problems you have, including a history of bipolar disorder
• All other medications you are currently taking and any medication allergies you have. This will help your prescriber assess for potential drug interactions.
• Other non-medication treatment you are receiving (such as psychotherapy (i.e., talk therapy) or substance abuse treatment). Your provider can explain how these different treatments work with the medication.
• If you are pregnant, plan to become pregnant, or are breast-feeding
• If you drink alcohol or use drugs

How should I take Cymbalta®?

Duloxetine is usually taken once or twice daily with food. Do not divide, cut, chew, crush, or place the capsules in water.

While the dose usually ranges from 30 mg to 120 mg, your healthcare provider will determine the dose that is right for you based upon your response.

What happens if I miss a dose of Cymbalta®?

If you miss a dose of duloxetine, take it as soon as you remember it, if it is not too close to when your next dose is due-discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.

What should I avoid while taking Cymbalta®?

Avoid drinking alcohol or using illegal drugs while you are taking antidepressant medications because the beneficial effects of the medication may be decreased and adverse effects may be increased (e.g., sedation).

What happens if I overdose with Cymbalta®?

If an overdose occurs, whether intentional or accidental, immediate medical attention may be necessary. Call your doctor or emergency medical service (911). You may also contact the poison control center (1-800-222-1222).

What are the possible side effects of Cymbalta®?

Common

Side effects with duloxetine are generally mild and are similar to those reported with other SNRI antidepressants. The most commonly reported side effects are nausea, diarrhea, headache, anxiety, dry mouth, insomnia, increased sweating, restlessness, sleepiness, yawning, flatulence, tremor, weight loss or gain, and dizziness. If you experience side effects after starting duloxetine they will often improve over the first week or two as you continue to take the medication.

Sexual side effects, such as problems with orgasm or ejaculatory delay may also occur, and often do not diminish over time.

Duloxetine has been associated with an increase in blood pressure. Patients taking duloxetine should have their blood pressure checked regularly and patients who already have high blood pressure should have their blood pressure under control before starting duloxetine.

Rare

Other side effects which may occur infrequently with duloxetine include increased heart rate, low blood pressure, increased salivation, irregular menstrual cycle, increased frequency of urination, changes in taste, increased liver enzymes, increased bleeding (e.g., gums may bleed more easily), low sodium, teeth grinding, and difficulty urinating.

Are there any risks for taking Cymbalta® for long periods of time?

To date, there are no known problems associated with long term use of duloxetine. It is a safe and effective medication when used as directed.

What other drugs may interact with Cymbalta®?

Duloxetine should not be taken with or within two weeks of taking monoamine oxidase inhibitors (MAOIs). These include phenelzine (Nardil®), tranycypromine (Parnate®), isocarboxazid (Marplan®), and selegeline (Emsam®).

Although rare, there is an increased risk of serotonin syndrome when duloxetine is used with other medications that increase serotonin, such as other antidepressants, migraine medications called "triptans" (e.g., Imitrex®), some pain medications (e.g., tramadol (Ultram®), meperidine (Demerol®)), and the antibiotic linezolid (Zyvox®).

Patients receiving warfarin (Coumadin®) therapy should be carefully monitored when duloxetine is initiated or discontinued. Increased bleeding has been reported when duloxetine is co-administered with warfarin, aspirin, or pain relievers known as NSAIDS (nonsteroidal anti-inflammatory drugs).

How long does it take for Cymbalta® to work?

While depressed mood and lack of interest in activities may need up to 4-6 weeks to improve, disturbances in sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working.

Like other medications used for anxiety disorders (e.g., GAD), duloxetine may take several weeks before it is fully effective. It is important to give the medication sufficient time before judging whether or not it will work for a given person.

Updated by
Ben Dishman, Pharm.D., BCPP
(March 2011)

FDA Alerts

Suicidal Thoughts or Actions in Children and Adults

Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications. This risk may persist until significant remission occurs.

In short-term studies, antidepressants increased the risk of suicidality in children, adolescents and young adults when compared to placebo. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24. Adults ages 65 and older taking antidepressants have a decreased risk of suicidality.

Patients, their families and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patients prescriber or healthcare professional. All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.

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