Generic Name: duloxetine (du LOX e teen)Brand Names: Cymbalta
Duloxetine is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). 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. It is also used to treat a chronic pain disorder called fibromyalgia, and to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy).
Duloxetine may also be used for other purposes not listed in this medication guide.
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.Call your doctor at once if you have any new or worsening symptoms 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 while taking duloxetine. Alcohol may increase the risk of damage to your liver. Duloxetine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use duloxetine:
seizures or epilepsy;
a bleeding or blood clotting disorder;
bipolar disorder (manic depression); or
a history of drug abuse or suicidal thoughts.
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.FDA pregnancy category C. Duloxetine may be harmful to an unborn baby, and may cause problems in a newborn baby if the mother takes the medication late in pregnancy (during the third trimester). Tell your doctor if you are pregnant or plan to become pregnant during treatment. Duloxetine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Older adults may be more sensitive to the side effects of this medication.Do not give duloxetine to anyone younger than 18 years old without the advice of a doctor.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from the medication.
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 a delayed-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. It may take 4 weeks or longer for your symptoms to improve. For best results, 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 duloxetine at room temperature away from moisture and heat.
See also: Duloxetine dosage in more detail
Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.
Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety). They can add to sleepiness caused by duloxetine.
Call your doctor at once if you have any new or worsening symptoms 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 any of these serious side effects:
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
painful or difficult urination;
easy bruising or bleeding, nosebleeds;
black, bloody, or tarry stools;
very stiff (rigid) muscles, high fever, vomiting, diarrhea, sweating, fast or uneven heartbeats, tremors, overactive reflexes;
headache, trouble concentrating, memory problems, confusion, hallucinations; or
weakness, feeling unsteady, loss of coordination, fainting, seizure, shallow breathing or breathing that stops.
Less serious side effects may include:
dry mouth, blurred vision;
drowsiness, dizziness, spinning sensation;
mild nausea, constipation, gas;
sleep problems (insomnia);
joint or muscle pain;
weight changes; or
decreased sex drive, impotence, or difficulty having an orgasm.
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.
Usual Adult Dose for Pain:
For use in the management of neuropathic pain associated with diabetic peripheral neuropathy: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.
Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with duloxetine may cause you to bruise or bleed easily.
Before taking duloxetine, tell your doctor if you are using any of the following medicines:
a blood thinner such as warfarin (Coumadin);
a diuretic (water pill);
lithium (Lithobid, Eskalith);
St. John's wort;
tryptophan (sometimes called L-tryptophan);
an antibiotic such as ciprofloxacin (Cipro);
almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
any other antidepressant such as desipramine (Norpramin), fluoxetine (Prozac, Sarafem), paroxetine (Paxil), and others.
This list is not complete and there may be other drugs that can interact with duloxetine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.