atomoxetine

What is the most important information I should know about atomoxetine?

Do not use atomoxetine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use atomoxetine before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to atomoxetine, or if you have glaucoma.

Some ADHD medicines have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Tell your doctor if you have any heart problems.

You may have suicidal thoughts or behavior while taking atomoxetine. Watch for symptoms of depression, unusual behavior, or thoughts of hurting yourself. Your doctor may need to check you at regular visits while you are taking this medication.

In addition to you watching for changes in your mood or behavior, your family or caregivers should be alert to changes in your mood or symptoms.

Do not use an open or broken capsule. If the medicine from inside the capsule gets into your eyes, rinse thoroughly with water and call your doctor.

Atomoxetine 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 atomoxetine?

Atomoxetine affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

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

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

What should I discuss with my healthcare provider before taking atomoxetine?

Do not use this medication if you are allergic to atomoxetine or if you have glaucoma.

Do not take atomoxetine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use atomoxetine before the MAO inhibitor has cleared from your body.

Some ADHD medicines have caused sudden death in children and adolescents with serious heart problems or congenital heart defects.

Before using atomoxetine, tell your doctor if you are allergic to any drugs, or if you have:

• a congenital heart defect;
• heart disease, a heart rhythm disorder, or recent heart attack;
• coronary artery disease;
• a history of stroke, blood clots, or heart attack;
• high or low blood pressure;
• liver disease;
• problems with urination;
• a personal or family history of mental illness, psychotic disorder, bipolar illness, depression, or suicide attempt; or
• if anyone in your family has died suddenly from a heart problem.

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

You may have suicidal thoughts or behavior while taking atomoxetine. Watch for symptoms of depression, unusual behavior, or thoughts of hurting yourself. Your doctor may need to check you at regular visits while you are taking this medication.

In addition to you watching for changes in your mood or behavior, your family or caregivers should be alert to changes in your mood or symptoms.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether atomoxetine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Atomoxetine is not meant for long-term use. Because ADHD may be a long-term condition, especially in children and young adults, your doctor may recommend another ADHD medication after you stop taking atomoxetine.

Long-term use of atomoxetine can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Do not give atomoxetine to a child younger than 6 years old without the advice of a doctor.

How should I take atomoxetine?

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. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Atomoxetine is usually taken once daily, but it may be taken in the morning and late afternoon. Follow your doctor's instructions.

It is important to use atomoxetine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not use a capsule that has been opened or accidentally broken. The medicine from inside the capsule can be dangerous if it gets in your eyes. If you must handle a broken capsule, ask your doctor or pharmacist how to safely handle and dispose of the tablet.

Store atomoxetine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose. Take the medication only one time per day.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include drowsiness, agitation, hyperactivity, unusual behavior, stomach problems, blurred vision, dry mouth, and fast heartbeat.

What should I avoid while taking atomoxetine?

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

Atomoxetine 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 atomoxetine?

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

Stop taking atomoxetine and call your doctor at once if you have a serious side effect such as:

• chest pain, shortness of breath, fast or uneven heartbeats;
• feeling light-headed or fainting;
• unusual thoughts or behavior, aggression, hallucinations (seeing things that are not there);
• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
• urinating less than usual or not at all.

Less serious side effects may include:

• feeling irritable;
• feeling dizzy or drowsy;
• nausea, vomiting, stomach pain, loss of appetite, constipation;
• cough, dry mouth;
• skin rash or itching;
• sleep problems (insomnia);
• increased menstrual cramps; or
• impotence, loss of interest in sex, or trouble 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 atomoxetine?

Before taking atomoxetine, tell your doctor if you are using any of the following drugs:

• albuterol (Proventil, Ventolin);
• amiodarone (Cordarone, Pacerone);
• bupropion (Wellbutrin, Zyban);
• celecoxib (Celebrex);
• cimetidine (Tagamet);
• doxorubicin (Adriamycin);
• methadone (Dolophine, Methadose);
• metoclopramide (Reglan);
• quinidine (Cardioquin, Quinaglute, Quinidex);
• ritonavir (Norvir);
• ranitidine (Zantac);
• terbinafine (Lamisil);
• antidepressants such as citalopram (Celexa), clomipramine (Anafranil); escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft); or
• antihistamines or sleep medicine such as diphenhydramine (Benadryl, Unisom, and others) or chlorpheniramine (Chlor-Trimeton and others).

This list is not complete and there may be other drugs that can interact with atomoxetine. 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 atomoxetine.

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: 4.04. Revision date: 11/28/2007.