DULOXETINE

(du LOX e teen) Brand: Cymbalta

What is the most significant information I must know about duloxetine?

• Do not use duloxetine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking duloxetine, you should wait at least 5 days till you start taking an MAOI.

• Message any new or worsening symptoms to your doctor, 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. It may magnify your risk of liver damage.

What is duloxetine?

• Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Duloxetine affects chemicals in the brain that may become unbalanced and reason depression.

• Duloxetine is used to treat major depressive mess and common anxiety disorder.

• Duloxetine is also used to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain).

• Duloxetine is also used to treat pain caused by nerve hurt in people with diabetes (diabetic neuropathy).

• Duloxetine may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking duloxetine?

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

• To create certain duloxetine is safety for you, speak your doctor if you have:

· liver or kidney disease;

· seizures or epilepsy;

· a bleeding or blood clotting disorder;

· tall blood pressure;

· glaucoma;

· bipolar mess (manic depression);

· a history of drug abuse or suicidal thoughts; or

· if you are being treated with methylene blue injection.

• Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using duloxetine. Your family or another caregivers must also be alert to changes in your mood or symptoms.

• FDA pregnancy category C. It is not known whether duloxetine will harm an unborn child. However, duloxetine may reason problems in a newborn if you take the medication during the third trimester of pregnancy. Speak your doctor if you are pregnant or plan to become pregnant while using this medication.

• If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to estimate any effects of duloxetine on the baby.

• Duloxetine can pass into breast milk and may harm a nursing child. You must not breast-feed while taking this medication.

• Older adults may be more sensitive to the side effects of this medication.

• Do not give this medication to a baby without medical advice.

How must I take duloxetine?

• Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.

• Try to take the medication at the same time every day. Follow the directions on your prescription label.

• Do not crush, chew, interrupt, or open an extended-release capsule. Swallow it intact.

• It may take 4 weeks or longer till your symptoms improve. Hold using the medicine as directed. Do not stop using duloxetine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medicine suddenly.

• Store at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking duloxetine?

• Avoid drinking alcohol. It may magnify your risk of liver damage.

• Duloxetine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What are the possible side effects of duloxetine?

• Get abnormal medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have:

· nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

· feeling like you might pass out;

· agitation, hallucinations, fever, quick heart course, overactive reflexes, vomiting, diarrhea, loss of coordination;

· very stiff (rigid) muscles, tall fever, sweating, confusion, tremors;

· light bruising, unusual bleeding;

· painful or difficult urination;

· headache, trouble concentrating, memory problems, weakness, feeling unsteady, seizure, shallow breathing or breathing that stops; or

· severe skin reaction -- fever, sore throat, swelling in your person or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the person or upper body) and causes blistering and peeling.

• Another general side effects may include:

· dry mouth;

· drowsiness;

· weary feeling;

· mild nausea or loss of appetite; or

· constipation.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect duloxetine?

• Conversation to your doctor till taking any medication for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen, naproxen, celecoxib, diclofenac, indomethacin, piroxicam, nabumetone, etodolac, and others. Taking any of these drugs with duloxetine may reason you to bruise or bleed easily.

• Taking duloxetine with another drugs that create you sleepy or slow your breathing can magnify these effects. Ask your doctor till taking duloxetine with a sleeping pill, narcotic pain medication, muscle relaxer, or medication for anxiety, depression, or seizures.

• Much drugs can interact with duloxetine. Not all possible interactions are listed here. Speak your doctor about all your medications and any you start or stop using during treatment with duloxetine, especially:

· a blood thinner such as warfarin, Coumadin;

· buspirone;

· cimetidine;

· a diuretic or "water pill";

· fentanyl;

· lithium;

· St. John's wort;

· tramadol;

· tryptophan (sometimes called L-tryptophan);

· an antibiotic such as ciprofloxacin;

· almotriptan, frovatriptan, sumatriptan, naratriptan, rizatriptan, or zolmitriptan; or

· any another antidepressant such as desipramine, fluoxetine, fluvoxamine, paroxetine, and others.

• This list is not complete and much another drugs can interact with duloxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal commodity. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about duloxetine.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.

(65)