Atomoxetine is used to treat attention deficit hyperactivity disorder (ADHD).

Atomoxetine may also be used for purposes not listed in this medication guide.

Some people have thoughts about suicide while taking atomoxetine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Atomoxetine may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Atomoxetine has caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take the medicine at the same time each day, with a full glass of water.

Atomoxetine is usually taken once daily in the morning, or two times per day in the morning and late afternoon. Follow your doctor's instructions.

You may take atomoxetine with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it. Tell your doctor if you have trouble swallowing the capsules.

Your doctor will need to check your progress on a regular basis. Your blood, heart rate, blood pressure, height and weight may also need to be checked often.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Attention Deficit Disorder:

-Initial Dose: 40 mg/day orally.
-Maintenance Dose: Increase dose to 80 mg/day orally after a minimum of 3 days at the initial dose.
-Maximum Dose: After 2 to 4 additional weeks, the dose may be increased up to 100 mg/day in patients who have not achieved an optimal response.

Comments: Take dose once a day in the morning OR as evenly divided doses in the morning and late afternoon/early evening.

Use: Treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Usual Pediatric Dose for Attention Deficit Disorder:

70 kg or Less:
-Initial Dose: 0.5 mg/kg/day orally.
-Maintenance dose: Increase dose to 1.2 mg/kg/day after a minimum of 3 days at the initial dose.
-Maximum dose: 1.4 mg/kg/day or 100 mg/day, whichever is less.

Over 70 kg:
-Initial Dose: 40 mg/day orally.
-Maintenance dose: Increase dose to 80 mg/day after a minimum of 3 days at the initial dose.
-Maximum dose: After 2 to 4 additional weeks, the dose may be increased up to 100 mg/day in patients who have not achieved an optimal response.

Comments: Take dose once a day in the morning OR as evenly divided doses in the morning and late afternoon/early evening.

Use: Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients age 6 and older.

Do not use atomoxetine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use atomoxetine if you are allergic to it, or if you have:

• severe heart or blood vessel problems;

• narrow-angle glaucoma; or

• pheochromocytoma (tumor of the adrenal gland).

Atomoxetine has caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

Tell your doctor if you have ever had:

• depression, mental illness, bipolar disorder, psychosis;

• suicidal thoughts or actions;

• low blood pressure; or

• liver disease.

Some people have thoughts about suicide while taking atomoxetine. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or plan to become pregnant.

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

It may not be safe to breastfeed while using atomoxetine. Ask your doctor about any risk.

Atomoxetine is not approved for use by anyone younger than 6 years old.

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 drowsiness, dizziness, stomach problems, tremors, or unusual behavior.

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.

Avoid using or handling an open or broken capsule. If the powder from inside the capsule gets in your eyes, rinse them with water right away and call your doctor.

Avoid driving or hazardous activity until you know how atomoxetine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Atomoxetine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using atomoxetine.

Atomoxetine may cause serious side effects. Call your doctor at once if you have:

• signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;

• signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;

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

• painful or difficult urination; or

• erection is painful or lasts longer than 4 hours (this is a rare side effect).

Common side effects of atomoxetine may include:

• nausea, vomiting, upset stomach, constipation;

• dry mouth, loss of appetite;

• mood changes, feeling tired;

• dizziness;

• urination problems; or

• impotence, trouble having an erection.

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.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• an antidepressant;

• asthma medication;

• blood pressure medicine; or

• a cold or allergy medicine that contains a decongestant such as pseudoephedrine or phenylephrine.

This list is not complete. Other drugs may affect atomoxetine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to atomoxetine.

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.