Duloxetine Treatment Report

Precautions

Instructions

Side Effects

Interactions

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;
• a bleeding or blood clotting disorder;
• glaucoma;
• 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.

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.

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.

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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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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);
• 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. You may report side effects to FDA at 1-800-FDA-1088.

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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);
• cimetidine (Tagamet);
• a diuretic (water pill);
• 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); 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.

Cymbalta and duloxetine

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