ARIPIPRAZOLE - aripiprazole solution 
Aurobindo Pharma Limited

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MEDICATION GUIDE

Aripiprazole Oral Solution
(ar'' i pip' ra zole)

What is the most important information I should know about aripiprazole oral solution?

(For other side effects, also see “What are the possible side effects of aripiprazole oral solution?”)

Serious side effects may happen when you take aripiprazole oral solution, including:


1.  Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?


Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

What else do I need to know about antidepressant medicines?


What is aripiprazole oral solution?

It is not known if aripiprazole oral solution is safe or effective in children:

Do not take aripiprazole oral solution if you are allergic to aripiprazole or any of the ingredients in aripiprazole oral solution. See the end of this Medication Guide for a complete list of ingredients in aripiprazole oral solution.

Before taking aripiprazole oral solution, tell your healthcare provider about all your medical conditions, including if you have or had:

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Aripiprazole oral solution and other medicines may affect each other causing possible serious side effects. Aripiprazole oral solution may affect the way other medicines work, and other medicines may affect how aripiprazole oral solution works.

Your healthcare provider can tell you if it is safe to take aripiprazole oral solution with your other medicines. Do not start or stop any medicines while taking aripiprazole oral solution without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take aripiprazole oral solution?

What should I avoid while taking aripiprazole oral solution?

What are the possible side effects of aripiprazole oral solution?

Aripiprazole oral solution may cause serious side effects, including:

Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving aripiprazole oral solution:

If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.

The most common side effects of aripiprazole oral solution in adults include:

The most common side effects of aripiprazole oral solution in children include:

These are not all the possible side effects of aripiprazole oral solution.

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 aripiprazole oral solution?

Keep aripiprazole oral solution and all medicines out of the reach of children.

General information about the safe and effective use of aripiprazole oral solution

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use aripiprazole oral solution for a condition for which it was not prescribed. Do not give aripiprazole oral solution to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about aripiprazole oral solution that was written for healthcare professionals.

What are the ingredients in
aripiprazole oral solution?

Active ingredient:
aripiprazole

Inactive ingredients:  edetate disodium, fructose, glycerin, hydrochloric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium hydroxide pellets and sucrose. The oral solution is flavored with orange flavor which containing benzyl alcohol and propylene glycol.


Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.
 

This Medication Guide has been approved by the U.S. Food and Drug Administration.


Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides


Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India

Revised: 02/2020

Revised: 2/2020
Aurobindo Pharma Limited