Drug Notebook

FDA Alerts

    Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Duloxetine is not approved for use in pediatric patients. (See Pediatric Use under Cautions.)
  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
  • Appropriately monitor and closely observe all patients who are started on duloxetine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)

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duloxetine
(du LOX e teen)

What is duloxetine?
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 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.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Cymbalta 20MG CPEP LILLY30/$120.83 or 90/$340.22
Cymbalta 30MG CPEP LILLY30/$130.32 or 90/$366.62
Cymbalta 60MG CPEP LILLY30/$131.39 or 90/$368.72

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What are the possible side effects of duloxetine?

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.

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:

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

  • restlessness, overactive reflexes, hallucinations, loss of coordination, fainting, coma;

  • nausea, vomiting, diarrhea, fever, and fast heartbeat;

  • easy bruising or bleeding, nosebleeds, or

  • black, bloody, or tarry stools.

Less serious side effects may include:

  • dry mouth;

  • drowsiness, dizziness, headache;

  • diarrhea, constipation;

  • sleep problems (insomnia);

  • weight changes;

  • feeling anxious or nervous, increased sweating; or

  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take duloxetine?
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.

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What is the most important information I should know about duloxetine?
Do not take duloxetine together with thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take duloxetine. After you stop taking duloxetine, you must wait at least 5 days before you start taking an MAOI. 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.

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What happens if I miss a dose?
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.

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What other drugs will affect duloxetine?
Before taking duloxetine, tell your doctor if you are using any of the following medicines: a blood thinner such as warfarin (Coumadin); cimetidine (Tagamet); fluvoxamine (Luvox); linezolid (Zyvox); lithium (Lithobid, Eskalith); St. John's wort; tramadol (Ultram); tryptophan (sometimes called L-tryptophan); an antibiotic such as ciprofloxacin (Cipro) or enoxacin (Penetrex); almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig);

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Duloxetine has been assigned to pregnancy category C by the FDA. Neonates exposed to SSRIs and SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. (Such complications can arise immediately upon delivery.) Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. (These features are consistent with either a direct toxic effect of SSRIs and SNRIs, or possibly a drug discontinuation syndrome.) In some cases, the clinical picture is consistent with serotonin syndrome. Animal studies on duloxetine have revealed evidence of adverse effects on embryo/fetal and postnatal development. There are no controlled data in human pregnancy. Duloxetine should be given during pregnancy and particularly during the third trimester, only if the potential benefits outweigh the potential risks to the fetus.

The physician may wish to consider tapering duloxetine in the third trimester.

Duloxetine is excreted into human milk. The effects in the nursing infant are unknown. According to the manufacturer, breast-feeding is not recommended during administration of duloxetine.

In lactating women receiving duloxetine, the daily infant dose, on a mg per kg basis, is estimated at approximately 0.14% of the maternal dose. Duloxetine and/or its metabolites are excreted into the milk of lactating rats.

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Who should NOT use this medication?

  • Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor. (See MAO Inhibitors under Cautions and see Specific Drugs under Interactions.)
  • Uncontrolled angle-closure glaucoma.
  • Known hypersensitivity to duloxetine or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical attention if you think you have taken too much of this medication. Overdose symptoms may include nausea, vomiting, diarrhea, agitation, confusion, hallucinations, fast heart rate, feeling light-headed, or fainting.

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What should I discuss with my healthcare provider before taking duloxetine?
Do not use duloxetine together with thioridazine (Mellaril), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam). Serious and sometimes fatal reactions can occur when these medicines are taken with duloxetine. You must wait at least 14 days after stopping an MAO inhibitor before you can take duloxetine. After you stop taking duloxetine, you must wait at least 5 days before you start taking an MAOI.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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