Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Duloxetine affects chemicals in the brain that may be unbalanced in people with depression.

Duloxetine is used to treat major depressive disorder in adults. It is also used to treat general anxiety disorder in adults and children who are at least 7 years old.

Duloxetine is also used in adults to treat nerve pain caused by diabetes (diabetic neuropathy), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain).

Some brands of duloxetine are also used to treat fibromyalgia (a chronic pain disorder). Drizalma is for treating fibromyalgia only in adults. Cymbalta may be used to treat fibromyalgia in adults and children at least 13 years old.

Do not take duloxetine within 5 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others. A dangerous drug interaction could occur.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Do not stop using duloxetine without first talking to your doctor.

Take duloxetine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Taking duloxetine in higher doses or more often than prescribed will not make it more effective, and may increase side effects.

Swallow the capsule whole and do not crush, chew, break, or open it.

You may take duloxetine with or without food.

Your blood pressure will need to be checked often.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Your symptoms may not improve for up to 4 weeks.

Do not stop using duloxetine suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Ask your doctor before stopping the medicine.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Depression:

Initial dose: 20 mg to 30 mg orally 2 times a day
Maintenance dose: 60 mg per day, given either once a day OR 30 mg orally 2 times a day
Maximum dose: 120 mg/day.

Usual Adult Dose for Fibromyalgia:

Initial dose: 30 mg orally once a day for at least 1 week
Maintenance dose: 30 to 60 mg orally once a day.

Usual Adult Dose for Generalized Anxiety Disorder:

Initial dose: 60 mg orally once a day
Maintenance dose: 60 to 120 mg orally once a day
Maximum dose: 120 mg/day.

Usual Adult Dose for Pain:

Initial dose: 30 to 60 mg orally once a day
Maintenance dose: 60 mg orally once a day.

Usual Adult Dose for Neuropathic Pain:

Initial dose: 30 to 60 mg orally once a day
Maintenance dose: 60 mg orally once a day.

Usual Adult Dose for Chronic Pain:

Initial dose: 30 to 60 mg orally once a day
Maintenance dose: 60 mg orally once a day.

Usual Geriatric Dose for Generalized Anxiety Disorder:

Initial dose: 30 mg orally once a day for at least 2 weeks
Maintenance dose: 60 mg orally once a day
Maximum dose: 120 mg/day.

Usual Pediatric Dose for Generalized Anxiety Disorder:

7 to 17 years:
-Initial dose: 30 mg orally once a day for at least 2 weeks
-Maintenance dose: 30 to 60 mg orally once a day
-Maximum dose: 120 mg/day.

Usual Pediatric Dose for Fibromyalgia:

13 years and older:
-Initial dose: 30 mg orally once a day for at least 1 week
-Maintenance dose: 30 to 60 mg orally once a day.

You should not use duloxetine if you are allergic to it.

Do not take duloxetine within 5 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine. A dangerous drug interaction could occur.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with duloxetine could cause a serious condition called serotonin syndrome.

Duloxetine is not approved for use by anyone younger than 7 years old.

To make sure duloxetine is safe for you, tell your doctor if you have:

• heart problems, high blood pressure;

• liver or kidney disease;

• slow digestion;

• a seizure;

• bleeding problems;

• sexual problems;

• narrow-angle glaucoma;

• bipolar disorder (manic depression);

• drug addiction or suicidal thoughts; or

• if you drink large amounts of alcohol.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Taking an SNRI antidepressant during late pregnancy could increase your risk of excessive bleeding after you give birth, and may cause serious medical complications in the baby. However, stopping the medicine may not be safe if you have a relapse of depression. Do not start or stop duloxetine without asking your doctor.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of duloxetine on the baby.

If you are breastfeeding, tell your doctor if you notice drowsiness, feeding problems, and slow weight gain in the nursing baby.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include vomiting, dizziness or drowsiness, seizures, fast heartbeats, fainting, or coma.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with duloxetine may cause you to bruise or bleed easily.

Avoid driving or hazardous activity until you know how duloxetine will affect you. Your reactions could be impaired. Dizziness or fainting can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Drinking alcohol may increase your risk of liver damage, especially if you take Drizalma.

Get emergency medical help if you have signs of an allergic reaction to duloxetine (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;

• a light-headed feeling, like you might pass out;

• easy bruising, unusual bleeding;

• vision changes;

• painful or difficult urination;

• liver problems - right-sided upper stomach pain, itching, dark urine, jaundice (yellowing of the skin or eyes);

• low blood sodium - headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or

• manic episodes - racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common duloxetine side effects may include:

• drowsiness;

• nausea, constipation, loss of appetite;

• dry mouth; or

• increased sweating.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with duloxetine may cause you to bruise or bleed easily.

Many drugs can interact with duloxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.