Aripiprazole (Page 10 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

NDC:68151-4459-8 in a CUP of 1 TABLETS

16.1 How Supplied


Aripiprazole Tablets have markings on one side and are available in the strengths and packages listed in Table 14. Table 14: Aripiprazole Tablet Presentations

Tablet Strength Tablet Color/Shape Tablet Markings Pack Size NDC Code
2 mg Off white to cream modified rectangle “251” Bottle of 30 Bottle of 60 Bottle of 100 Bottle of 180 Bottle of 500 Bottle of 1000 13811-679-30 13811-679-60 13811-679-10 13811-679-18 13811-679-50 13811-679-01
5 mg Light pink modified rectangle “250” Bottle of 30 Bottle of 60 Bottle of 100 Bottle of 180 Bottle of 1000 13811-680-30 13811-680-60 13811-680-10 13811-680-18 13811-680-01
10 mg White to off white modified rectangle “252” Bottle of 30 Bottle of 100 Bottle of 500 Bottle of 1000 13811-681-30 13811-681-10 13811-681-50 13811-681-01
15 mg White to off white round “253” Bottle of 30 Bottle of 100 Bottle of 500 Bottle of 1000 13811-682-30 13811-682-10 13811-682-50 13811-682-01
20 mg White to off white round “L254” Bottle of 30 Bottle of 100 Bottle of 500 Bottle of 1000 13811-683-30 13811-683-10 13811-683-50 13811-683-01
30 mg White to off white round “L255” Bottle of 30 Bottle of 100 Bottle of 500 Bottle of 1000 13811-684-30 13811-684-10 13811-684-50 13811-684-01

16.2 Storage


Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Tablets

17 PATIENT COUNSELING INFORMATION

See Medication Guide

Patients, their families, and caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with aripiprazole and should counsel them in its appropriate use. A patient Medication Guide including information about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for aripiprazole. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. It should be noted that aripiprazole tablets are not approved as a single agent for treatment of depression and has not been evaluated in pediatric major depressive disorder. Discuss the following issues with patients prescribed aripiprazole: Clinical Worsening of Depression and Suicide Risk
and indicate a need for very close monitoring and possibly changes in the medication [see WARNINGS AND PRECAUTIONS (5.2)].

Because aripiprazole may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that aripiprazole therapy does not affect them adversely Interference with Cognitive and Motor Performance
[see WARNINGS AND PRECAUTIONS (5.9)].

Advise patients that breastfeeding is not recommended with aripiprazole treatment because of the potential for serious adverse reactions in a nursing infant Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions Nursing
[see USE IN SPECIFIC POPULATIONS (8.3)].
Concomitant Medication
[see DRUG INTERACTIONS (7)].

Patients should be advised regarding appropriate care in avoiding overheating and dehydration ABILIFY® is a trademark of Otsuka Pharmaceutical Company. Heat Exposure and Dehydration
[see WARNINGS AND PRECAUTIONS (5.10)].

Made in India.

Manufactured for: Trigen Laboratories LLC Sayreville, NJ 08872 www.trigenlab.com Revision: 10/2015

Medication Guide

Aripiprazole (AR-i-PIP-ra-zole ) Tablets

Read this Medication Guide before you start taking aripiprazole and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

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

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

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

• Medicines like aripiprazole can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole is not approved for the treatment of patients with dementia-related psychosis. • Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions: Increased risk of death in elderly patients with dementia-related psychosis:
Risk of suicidal thoughts or actions:

1 .Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. These include people who have (or have a family history of) suicidal thoughts or actions. 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.

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

•Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. •Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. •Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.


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:

•thoughts about suicide or dying •attempts to commit suicide •new or worse depression •new or worse anxiety •feeling very agitated or restless •panic attacks •trouble sleeping (insomnia) •new or worse irritability •acting aggressive, being angry, or violent •acting on dangerous impulses •an extreme increase in activity and talking (mania) •other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

• Stopping an antidepressant medicine suddenly can cause other symptoms. • . It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. • Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. • . Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. • Talk to your child’s healthcare provider for more information. Never stop an antidepressant medicine without first talking to a healthcare provider.
Antidepressants are medicines used to treat depression and other illnesses
Antidepressant medicines have other side effects.
Antidepressant medicines can interact with other medicines
Not all antidepressant medicines prescribed for children are FDA approved for use in children.

What is aripiprazole?

Aripiprazole is a prescription medicine used to treat:

•schizophrenia

It is not known if aripiprazole is safe or effective in children: •under 13 years of age with schizophrenia are allergic to aripiprazole or any of the ingredients in aripiprazole. See the end of this Medication Guide for a in aripiprazole.
Who should not take aripiprazole? Do not take aripiprazole if you
complete list of ingredients

What should I tell my healthcare provider before taking aripiprazole?

Before taking aripiprazole, tell your healthcare provider if you have or had:

•diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start aripiprazole and also during therapy. •seizures (convulsions). •low or high blood pressure. •heart problems or stroke. •pregnancy or plans to become pregnant. It is not known if aripiprazole will harm your unborn baby. •breast-feeding or plans to breast-feed. Aripiprazole can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive aripiprazole. •low white blood cell count. •any other medical conditions.

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

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

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

•Take aripiprazole exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking aripiprazole yourself. •Aripiprazole can be taken with or without food. •Aripiprazole tablets should be swallowed whole. •If you miss a dose of aripiprazole, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of aripiprazole at the same time. •If you take too much aripiprazole, call your healthcare provider or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

What should I avoid while taking aripiprazole?

•Do not drive, operate heavy machinery, or do other dangerous activities until you know how aripiprazole affects you. Aripiprazole may make you drowsy. •Avoid getting over-heated or dehydrated. oDo not over-exercise. oIn hot weather, stay inside in a cool place if possible. oStay out of the sun. Do not wear too much or heavy clothing. oDrink plenty of water.

What are the possible side effects of aripiprazole?

Aripiprazole may cause serious side effects, including:

• • • 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. • 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. • • Increases in blood sugar can happen in some people who take aripiprazole. 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 and during your treatment. See “ ?” What is the most important information I should know about aripiprazole
Stroke in elderly people (cerebrovascular problems) that can lead to death
Neuroleptic malignant syndrome (NMS).
Uncontrolled body movements (tardive dyskinesia).
Problems with your metabolism such as:
High blood sugar (hyperglycemia) and diabetes.

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

  • 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

• • You and your healthcare provider should check your weight regularly. • Lightheadedness or fainting when rising too quickly from a sitting or lying position. • See “What should I avoid while receiving aripiprazole?” • increased fat levels (cholesterol and triglycerides) in your blood.
weight gain.
Orthostatic hypotension (decreased blood pressure).
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.
difficulty swallowing that can cause food or liquid to get into your lungs.

The most common side effects of aripiprazole 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 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. For more information, ask your healthcare provider or pharmacist.

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?

•Store aripiprazole at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Keep aripiprazole and all medicines out of the reach of children.

General information about the safe and effective use of aripiprazole

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

This Medication Guide summarizes the most important information about aripiprazole. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about aripiprazole that was written for healthcare professionals. For more information about aripiprazole call Trigen Laboratories, LLC at 888 9 TRIGEN (888-987-4436).

What are the ingredients in aripiprazole tablets?

aripiprazole Active ingredient:

corn starch, hydroxypropyl cellulose, lactose monohydrate, crospovidone, colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. Colorants include ferric oxide (yellow or red). Inactive ingredients:
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.

ABILIFY® is a trademark of Otsuka Pharmaceutical Company. Made in India.

Manufactured for: Trigen Laboratories, LLC Sayreville, NJ 08872

www.trigenlab.com Trigen Laboratories LLC

Revised: 10/2015

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