atomoxetine

Generic Name: atomoxetine (AT oh mox e teen)Brand Names: Strattera

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 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 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.

If you have certain conditions, you may need a dose adjustment or special tests to safely take atomoxetine. Before taking atomoxetine, tell your doctor 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.

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. It is not known whether atomoxetine is harmful to an unborn baby. Before taking this medication, 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.

See also: Atomoxetine dosage in more detail

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.

Atomoxetine side effects

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);

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• 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;

• 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Atomoxetine Dosing Information

Usual Adult Dose for Attention Deficit Disorder:

40 mg once a day the morning. Alternatively, the dose may be administered as 20 mg orally twice a day, in the morning and late afternoon/early evening.The dose may be increased after a minimum of three days to a target total daily dose of approximately 80 mg administered as either a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. After two to four weeks, the dose may be increased to a maximum of 100 mg in patients who have not received optimal response.There are no data to support increased effectiveness at higher doses.

Usual Pediatric Dose for Attention Deficit Disorder:

Less than 6 years: The safety and efficacy of atomoxetine in patients less than 6 years of age have not been established.Greater than or equal to 6 years of age and up to 70 kg body weight:0.5 mg/kg once a day in the morning. Alternatively, the dose may be administered as 0.25 mg/kg orally twice a day, in the morning and late afternoon/early evening.The dose may then be increased after a minimum of three days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening.No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day.Greater than or equal to 6 years of age and over 70 kg body weight:40 mg once a day the morning. Alternatively, the dose may be administered as 20 mg orally twice a day, in the morning and late afternoon/early evening.The dose may be increased after a minimum of three days to a target total daily dose of approximately 80 mg administered as either a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. After two to four weeks, the dose may be increased to a maximum of 100 mg in patients who have not received optimal response.There are no data to support increased effectiveness at higher doses.

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 1996-2006 Cerner Multum, Inc. Version: 5.03. Revision Date: 06/05/2009 8:33:28 AM.