Duloxetine

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.

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.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by duloxetine. Tell your doctor if you regularly use any of these other medicines.

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.

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.

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.

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

Before taking duloxetine, tell your doctor if you are allergic to any drugs, or if you have:

• liver or kidney disease;
• seizures or epilepsy;
• bipolar disorder (manic depression); or
• a history of drug abuse or suicidal thoughts.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take duloxetine.

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.

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.

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.

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.

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.

What should I avoid while taking duloxetine?

Avoid drinking alcohol while taking duloxetine. Alcohol may increase the risk of damage to your liver.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by duloxetine. Tell your doctor if you regularly use any of these other medicines.

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.

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:

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

Less serious side effects may include:

• constipation;
• drowsiness, dizziness, headache;
• sleep problems (insomnia);
• weight changes;
• feeling anxious or nervous, increased sweating;
• sore throat; 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.

What other drugs will affect duloxetine?

Before taking duloxetine, tell your doctor if you are using any of the following medicines:

• cimetidine (Tagamet);
• linezolid (Zyvox);
• lithium (Lithobid, Eskalith);
• St. John's wort;
• tramadol (Ultram);
• tryptophan (sometimes called L-tryptophan);
• almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
• any other antidepressants such as amitriptyline (Elavil), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), protriptyline (Vivactil), sertraline (Zoloft), trimipramine (Surmontil), or venlafaxine (Effexor).

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.

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.

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 1996-2003 Cerner Multum, Inc. Version: 2.08. Revision date: 10/01/2007.