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STRATTERA®( Atomoxetine HCl )

Atomoxetine (at-OH-mox-e-teen) belongs to the group of medicines called selective norepinephrine reuptake inhibitor. It is used to treat children, adolescents, and adults with attention-deficit hyperactivity disorder (ADHD).

Atomoxetine increases attention and decreases restlessness in people who are overactive, cannot concentrate for very long or are easily distracted, and are emotionally unstable. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

Atomoxetine is used as part of a total treatment program to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children and adults with ADHD. Atomoxetine is in a class of medications called selective norepinephrine reuptake inhibitors. It works by increasing the levels of norepinephrine, a natural substance in the brain that is needed to control behavior.

Atomoxetine comes as a capsule to take by mouth. It is usually taken with or without food either once a day in the morning, or twice a day in the morning and late afternoon or early evening. Take atomoxetine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take atomoxetine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow atomoxetine capsules whole; do not open, chew, or crush them. If a capsule is accidentally broken or opened, wash away the loose powder with water right away. Try not to touch the powder and be especially careful not to get the powder in your eyes. If you do get powder in your eyes, rinse them with water right away and call your doctor.

Your doctor will probably start you on a low dose of atomoxetine and increase your dose after at least 3 days. Your doctor may increase your dose again after 2-4 weeks.

Atomoxetine may help control the symptoms of ADHD but does not cure the condition. Continue to take atomoxetine even if you feel well. Do not stop taking atomoxetine without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

  • Before taking atomoxetine, tell your doctor and pharmacist if you are allergic to atomoxetine, any other medications, or any of the inactive ingredients in atomoxetine capsules.
  • Do not take atomoxetine if you are taking monoamine oxidase (MAO) inhibitors, including isocaraboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate), or if you have stopped taking them within the past 2 weeks. If you stop taking atomoxetine, you should wait at least 2 weeks before you start taking an MAO inhibitor.
  • Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: albuterol syrup or tablets (Proventil, Ventolin), amiodarone (Cordarone, Pacerone), bupropion (Wellbutrin), chlorpheniramine (antihistamine in cold medications),cimetidine (Tagamet), clomipramine (Anafranil), fluoxetine (Prozac, Sarafem), haloperidol (Haldol), metaproterenol syrup or tablets (Metaprel), medications for high blood pressure, methadone (Dolophine), metoclopramide (Reglan), nefazodone, paroxetine (Paxil), quinidine, ritonavir (Norvir), sertraline (Zoloft), ticlopidine (Ticlid), and venlafaxine (Effexor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • Tell your doctor if you or anyone in your family has or has ever had depression or bipolar disorder (manic depressive disorder; a condition that causes episodes of depression, episodes of frenzied, abnormal excitement and other abnormal moods) or has ever thought about or attempted suicide. Also tell your doctor if you have or have ever had glaucoma (an eye disease that may cause vision loss), high or low blood pressure, fast or irregular heartbeat, a stroke, a ministroke, or heart or liver disease.
  • Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking atomoxetine, call your doctor.
  • You should know that atomoxetine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • You should know that atomoxetine has caused severe liver damage in some patients. Call your doctor right away if you have any of the following symptoms: itchy skin, dark urine, yellowing of your skin or eyes, pain in the upper right part of your stomach, or flu-like symptoms.
  • You should know that atomoxetine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • You should know that atomoxetine should be used as part of a total treatment program for ADHD, which may include counseling and special education. Make sure to follow all of your doctor's and/or therapist's instructions.

Dietary instructions:

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

Missed dose:

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not take more than the prescribed daily amount of atomoxetine in 24 hours.

Side Effects

Tell your doctor if any of these symptoms are severe or do not go away:

  • heartburn
  • upset stomach
  • vomiting
  • loss of appetite
  • weight loss
  • constipation
  • stomach pain
  • gas
  • dry mouth
  • excessive tiredness
  • dizziness
  • headache
  • mood swings
  • decreased sex drive or ability
  • difficulty urinating
  • painful or irregular menstrual periods
  • cough
  • runny nose
  • pain or pressure in the face
  • fever
  • chills
  • muscle pain
  • sweating
  • hot flashes
  • difficulty falling asleep or staying asleep
  • unusual dreams
  • burning or tingling in the hands, arms, feet, or legs

If you experience any of the following symptoms, call your doctor immediately:

  • fast or pounding heartbeat
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • hoarseness
  • difficulty swallowing or breathing
  • hives
  • rash
  • aggressive or violent behavior

Atomoxetine may slow down children's growth or weight gain. Your child's doctor will probably monitor him or her carefully during his or her treatment with atomoxetine. Talk to your child's doctor about the risks of giving this medication to your child.

Atomoxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage

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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

Symptoms of overdose may include:

  • sleepiness
  • agitation
  • an increase in activity or talking
  • abnormal behavior
  • stomach problems
  • wide pupils (black circles in the middle of the eyes)
  • fast heartbeat
  • dry mouth

In case of emergency/overdose:
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

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