ATOMOXETINE HYDROCHLORIDE- atomoxetine hydrochloride capsule
Atomoxetine Capsules, USP
(a" toe mox’ e teen)
Read the Medication Guide that comes with atomoxetine capsules before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your treatment or your child’s treatment with atomoxetine.
What is the most important information I should know about atomoxetine capsules?
The following have been reported with use of atomoxetine:
1.Suicidal thoughts and actions in children and teenagers:
Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from atomoxetine clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions. Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager’s doctor if your child or teenager (or there is a family history of):
The chance for suicidal thoughts and actions may be higher:
Prevent suicidal thoughts and action in your child or teenager by:
Watch for the following signs in your child or teenager during atomoxetine treatment:
Call your child or teenager’s doctor right away if they have any of the above signs, especially if they are new, sudden, or severe. Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.
2. Severe liver damage:
Atomoxetine can cause liver injury in some patients. Call your doctor right away if you or your child has the following signs of liver problems:
3. Heart-related problems:
Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting atomoxetine.
Your doctor should check your blood pressure or your child’s blood pressure and heart rate regularly during treatment with atomoxetine.
Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking atomoxetine.
4. New mental (psychiatric) problems in children and teenagers:
Call your child or teenager’s doctor right away about any new mental symptoms because adjusting or stopping atomoxetine treatment may need to be considered.
What are atomoxetine capsules?
Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Atomoxetine should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Atomoxetine has not been studied in children less than 6 years old.
Who should not take atomoxetine capsules?
Atomoxetine should not be taken if you or your child:
Atomoxetine capsules may not be right for you or your child. Before starting atomoxetine tell your doctor or your child’s doctor about all health conditions (or a family history of) including:
Can atomoxetine capsules be taken with other medicines?
Tell your doctor about all the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. Atomoxetine and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether atomoxetine can be taken with other medicines.
Especially tell your doctor if you or your child takes:
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking atomoxetine capsules without talking to your doctor first.
How should atomoxetine capsules be taken?
What are possible side effects of atomoxetine capsules?
See “What is the most important information I should know about atomoxetine capsules?” for information on reported suicidal thoughts and actions, other mental problems, severe liver damage, and heart problems.
Other serious side effects include:
Common side effects in children and teenagers include:
Common side effects in adults include:
Other information for children, teenagers, and adults:
This is not a complete list of possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store atomoxetine capsules?
General information about atomoxetine capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use atomoxetine for a condition for which it was not prescribed. Do not give atomoxetine to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about atomoxetine capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atomoxetine capsules that was written for healthcare professionals. For more information call Apotex Corp. at 1-800-706-5575 or visit www.apotex.com.
What are the ingredients in atomoxetine capsules?
Active ingredient: atomoxetine hydrochloride, USP.
Inactive ingredients: The capsules also contain pregelatinized starch. The capsule shells contain gelatin and titanium dioxide. The capsule shells may also contain one or more of the following: FD&C Blue No. 2 (25 mg, 40 mg, and 60 mg), iron oxide red (80 mg and 100 mg), and iron oxide yellow (18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg). The capsules are imprinted with edible black ink (comprised of ammonia solution, iron oxide black, potassium hydroxide, propylene glycol, and shellac.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All registered trademarks in this document are the property of their respective owners.
ATOMOXETINE CAPSULES, USP
10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg
|Manufactured by:||Manufactured for:|
|Apotex Inc.||Apotex Corp.|
|Toronto, Ontario||Weston, Florida|
|Canada M9L 1T9||USA 33326|
Revised: February 2022