ARIPIPRAZOLE - aripiprazole tablet 
Ascend Laboratories, LLC

----------

MEDICATION GUIDE

Aripiprazole Tablets, USP (AR i PIP ra zole)

What is the most important information I should know about Aripiprazole Tablets?

(For other side effects, also see “What are the possible side effects of  Aripiprazole Tablets?").

Serious side effects may happen when you take aripiprazole tablets, 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 Tablets?
Aripiprazole Tablets is a prescription medicine used to treat:


It is not known if Aripiprazole is safe or effective in children:


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

  

Before taking aripiprazole tablets, 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 Tablets and other medicines may affect each other causing possible serious side effects. Aripiprazole Tablets may affect the way other medicines work, and other medicines may affect how aripiprazole tablets works.

Your healthcare provider can tell you if it is safe to take aripiprazole tablets with your other medicines. Do not start or stop any medicines while taking aripiprazole tablets 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 Tablets?


What should I avoid while taking Aripiprazole Tablets?


What are the possible side effects of Aripiprazole Tablets?
Aripiprazole Tablets may cause serious side effects, including:
• See “What is the most important information I should know about Aripiprazole Tablets?”
Stroke in elderly people (cerebrovascular problems) that can lead to death
• Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.
Uncontrolled body movements (tardive dyskinesia). Aripiprazole may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving aripiprazole. Tardive dyskinesia may also start after you stop receiving aripiprazole.
• Problems with your metabolism such as: 
    • High blood sugar (hyperglycemia) and diabetes: Increases in blood sugar can happen in some people who take aripiprazole tablets. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start aripiprazole tablets and during your treatment.
Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving  aripiprazole tablets: 
• feel very thirsty
• need to urinate more than usual
• feel very hungry
• feel weak or tired
• feel sick to your stomach
• feel confused, or your breath smells fruity.

   • Increased fat levels (cholesterol and triglycerides) in your blood.
   • W
eight gain. You and your healthcare provider should check your weight regularly.
• Unusual urges. Some people taking aripiprazole have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges.
If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.


• Orthostatic hypotension (decreased blood pressure): Lightheadedness or fainting may happen when rising too quickly from a sitting or lying position.
Falls: Aripiprazole may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
Low white blood cell count
Seizures (convulsions)
problems with control of your body temperature especially when you exercise a lot or are in an area that is very hot. It is important for you to drink water to avoid dehydration. See “What should I avoid while receiving aripiprazole?"
Difficulty swallowing that can cause food or liquid to get into your lungs. 
The most common side effects of aripiprazole tablets in adults include:
• Nausea
• dizziness
• vomiting
• anxiety
• constipation
• insomnia
• headache
• restlessness
• blurred vision
• inner sense of restlessness/need to move (akathisia)
• upper respiratory illness
The most common side effects of aripiprazole tablets in children include:
• feeling sleepy
• insomnia
• headache
• nausea
• vomiting
• stuffy nose
• fatigue
• weight gain
• increased or decreased appetite
• uncontrolled movement such as restlessness, tremor,muscle stiffness
• increased saliva or drooling

These are not all the possible side effects of aripiprazole tablets. 
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 Tablets, USP?
• Store aripiprazole tablets, USP at room temperature, between 68°F to 77°F (20°C to 25°C).
Keep aripiprazole tablets and all medicines out of the reach of children.


General information about the safe and effective use of Aripiprazole Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use aripiprazole tablets for a condition for which it was not prescribed. Do not give aripiprazole tablets to other people, even if they have the same symptoms as you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about aripiprazole tablets that was written for healthcare professionals.

For more information call 1-877-ASC-RX01 (877-272-7901).


What are the ingredients in Aripiprazole Tablets, USP?

Active ingredient: Aripiprazole, USP

Inactive ingredients: lactose monohydrate, corn starch, hydroxyl propyl cellulose, microcrystalline cellulose 101, magnesium stearate. Colorants include FD&C blue #2/indigo carmine AL11-14%, yellow ferric oxide, red ferric oxide.

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.

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

Manufactured in India by:

Alkem Laboratories Limited

Mumbai – 400 013, INDIA

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: October,2019
PT 2166-02

Revised: 5/2021
Ascend Laboratories, LLC