Atomoxetine

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Atomoxetine


Generic Name: Atomoxetine (AT-oh-mox-e-teen)
Brand Name: Strattera

Use of Atomoxetine may increase the risk of suicidal thinking and behavior in children and adolescents with attention-deficit hyperactivity disorder (ADHD). Anyone considering the use of Atomoxetine or any antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on Atomoxetine should be watched closely for worsening of symptoms, suicidal thoughts and behavior, or unusual behavior changes. Families and caregivers should be aware of the need for close observation of the patient and communication with the doctor. Results from several studies in children and adolescents with certain psychiatric disorders have shown a greater risk of side effects related to suicidal thinking and behavior during the first few months of treatment with Atomoxetine . No suicides occurred during studies in children and adolescents with ADHD.


Atomoxetine is used for:

Treating ADHD as part of a full treatment program.

Atomoxetine is a selective norepinephrine reuptake inhibitor. It works by helping to restore the balance of certain natural chemicals in the brain.

Do NOT use Atomoxetine if:

  • you are allergic to any ingredient in Atomoxetine
  • you are currently taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
  • you have narrow-angle glaucoma

Contact your doctor or health care provider right away if any of these apply to you.

Before using Atomoxetine :

Some medical conditions may interact with Atomoxetine . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver disease, high blood pressure, heart or blood vessel disease, a fast heartbeat, difficulty urinating, or bipolar disorder

Some MEDICINES MAY INTERACT with Atomoxetine . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • MAO inhibitors (eg, phenelzine) because serious, sometimes fatal, reactions could occur
  • Quinidine or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because side effects and toxic effects may be increased
  • Albuterol because the risk of side effects may be increased by Atomoxetine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Atomoxetine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Atomoxetine :

Use Atomoxetine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Atomoxetine comes with an additional patient leaflet. Read it carefully and reread it each time you get Atomoxetine refilled.
  • Atomoxetine may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Atomoxetine is usually taken either as a single dose in the morning or divided into 2 doses in the morning and late afternoon/early evening, or as directed by your doctor.
  • Continue to use Atomoxetine even if you feel well. Do not miss any doses.
  • If you miss a dose of Atomoxetine , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Atomoxetine .

Important safety information:

  • Atomoxetine may cause dizziness, drowsiness, lightheadedness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Atomoxetine . Using Atomoxetine alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • Atomoxetine may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
  • Atomoxetine can increase suicidal thoughts and behaviors in some children and teenagers. This risk may be higher in individuals with bipolar illness (also called manic-depressive illness), a family history of bipolar illness, or a history of attempting suicide. Pay close attention to changes in moods or actions, especially if changes occur suddenly. Contact your health care provider right away if any of the following effects occur or worsen: depression, anxiety, restlessness or irritability, panic attacks, thoughts or attempts of suicide, or other unusual changes in behavior or mood.
  • LAB TESTS, including pulse, blood pressure, and liver tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Atomoxetine with caution in the ELDERLY because they may be more sensitive to its effects, especially dizziness.
  • Atomoxetine is not recommended for use in CHILDREN younger than 7 years of age. Safety and effectiveness in this age group have not been confirmed. Atomoxetine may affect growth rate in CHILDREN. Growth should be checked regularly while using Atomoxetine , especially if they experience side effects of the medicine, such as loss of appetite or weight loss.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Atomoxetine during pregnancy. It is unknown if Atomoxetine is excreted in breast milk. If you are or will be breast-feeding while you are using Atomoxetine , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Atomoxetine :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; coughing; decreased appetite; decreased interest in sex; dizziness; drowsiness; dry mouth; ear infection; fatigue; headache; indigestion; irritability; menstrual cycle changes; mood swings; nausea; skin irritation; sleeplessness; stomach upset; tiredness; urinary hesitancy; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal or stomach pain or tenderness; blurred vision; changes in sexual ability (such as impotence or ejaculation problems); dark urine; difficulty urinating; pale stools; severe headache; tremors; unexplained flu-like symptoms; unusual fatigue or tiredness; unusually fast heartbeat; weight loss; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include severe headache; unusually fast heartbeat.

Proper storage of Atomoxetine :

Store Atomoxetine at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Atomoxetine out of the reach of children and away from pets.

General information:

  • If you have any questions about Atomoxetine , please talk with your doctor, pharmacist, or other health care provider.
  • Atomoxetine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Atomoxetine . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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