Increased risk of suicidal ideation observed in short-term clinical trials in children and adolescents with attention deficit hyperactivity disorder (ADHD). (See Suicidality Risk and also see Pediatric Use, under Cautions.) Balance risk of suicidality against the clinical need for the drug.
Closely monitor patients initiating atomoxetine therapy; advise family members and caregivers of the need for close observation and communication with the clinician.
Indicated for treatment of ADHD in pediatric patients and adults; not approved for treatment of major depressive disorder.
ATOMOXETINE (AT oh mox e teen) is used to treat attention deficit/hyperactivity disorder, also known as ADHD. It is not a stimulant like other drugs for ADHD. This drug can improve attention span, concentration, and emotional control. It can also reduce restless or overactive behavior.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. If you have difficulty sleeping and you take more than 1 dose per day, take your last dose before 6 PM. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 years for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
medicines that increase blood pressure like ephedrine
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
It may take a week or more for this medicine to take effect. This is why it is very important to continue taking the medicine and not miss any doses. If you have been taking this medicine regularly for some time, do not suddenly stop taking it. Ask your doctor or health care professional for advice.
Rarely, this medicine may increase thoughts of suicide or suicide attempts in children and teenagers. Call your child's health care professional right away if your child or teenager has new or increased thoughts of suicide or has changes in mood or behavior like becoming irritable or anxious. Regularly monitor your child for these behavioral changes.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.
Do not treat yourself for coughs, colds or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
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.
