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a-toe-MOX-e-teen
Increased risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Monitor patients closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Close observation and communication with the prescriber by families and caregivers is recommended .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Central Nervous System Agent
Pharmacologic Class: Norepinephrine Reuptake Inhibitor
Atomoxetine belongs to the group of medicines called selective norepinephrine reuptake inhibitors (SNRI). It is used to treat children, teenagers, 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. atomoxetine is used as part of a treatment program that also includes social, educational, and psychologic treatment.
atomoxetine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For atomoxetine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to atomoxetine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of atomoxetine in children. However, safety and efficacy have not been established for pediatric patients younger than 6 years of age.
Appropriate studies on the relationship of age to the effects of atomoxetine have not been performed in the geriatric population.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using atomoxetine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using atomoxetine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using atomoxetine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of atomoxetine. Make sure you tell your doctor if you have any other medical problems, especially:
Take atomoxetine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
If you or your child think atomoxetine is not working properly after you have taken it for several weeks, do not increase the dose. Instead, check with your doctor.
atomoxetine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the capsule whole. Do not crush, break, chew, or open it.
Atomoxetine may be taken with or without food.
Avoid touching a broken or opened capsule. Wash your hands that touched an opened capsule with water immediately. If atomoxetine comes in contact with your eyes or your child's eyes, rinse it with water and call your doctor right away.
The dose of atomoxetine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of atomoxetine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of atomoxetine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check you or your child's progress at regular visits to make sure atomoxetine is working properly. Blood tests may be needed to check for unwanted effects.
atomoxetine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to atomoxetine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
You should not use atomoxetine if you have used a drug for depression called a MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, within the past 14 days.
Tell your doctor about all the medicines you or your child take or plan to take, including prescription and nonprescription (over-the-counter) medicines, dietary supplements, and herbal remedies.
Tell your doctor if you or your child are nursing, pregnant, or thinking of becoming pregnant.
Call your doctor right away if you or your child get swelling, hives, or if you develop any symptoms that concern you.
Tell your doctor right away if you or your child get a skin rash, dark urine, persistent loss of appetite, yellow eyes or skin, flu-like symptoms or right upper belly pain or tenderness. These could be symptoms of a serious liver problem.
Do not give atomoxetine to other people, even if they have the same symptoms that you or your child have.
Atomoxetine may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, shortness of breath, or fainting while taking atomoxetine.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking atomoxetine, or when the dose is increased.
Tell your doctor right away if you, your child, or your family or caregiver notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.
atomoxetine may cause slow growth. If your child is using atomoxetine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.
If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less commonSome side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More commonOther side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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