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ABILIFY- aripiprazole tablet


  1. Patient Information
  2. What Is The Most Important Information I Should Know About Abilify?
  3. 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:
  4. What Is Abilify?
  5. It Is Not Known If Abilify Is Safe Or Effective In Children:
  6. Who Should Not Take Abilify?
  7. Before Taking Abilify, Tell Your Healthcare Provider If You Have Or Had:
  8. How Should I Take Abilify?
  9. What Should I Avoid While Taking Abilify?
  10. Abilify May Cause Serious Side Effects, Including:
  11. Active Ingredient:
  12. Tablets:
  13. Abilify Discmelt Orally Disintegrating Tablets:
  14. Abilify Oral Solution:
  15. Discuss The Following Issues With Patients Prescribed Abilify:
  16. How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions In Myself Or A Family Member?
  17. What Else Do I Need To Know About Antidepressant Medicines?

Patient Information 

ABILIFY (a BIL f )

(aripiprazole)

Tablets

ABILIFY (a BIL f )

(aripiprazole)

Orally Disintegrating Tablets

ABILIFY (a BIL f )

(aripiprazole)

Oral Solution

ABILIFY (a BIL f )

(aripiprazole)

Injection, for intramuscular use

Read this Medication Guide before you start taking ABILIFY 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 Abilify? 

(For other side effects, also

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 Is Abilify? 

ABILIFY Oral Tablets, Orally-Disintegrating Tablets, and Oral Solutionare prescription medicines used to treat:
o
Schizophrenia
o
manic or mixed episodes that happen with bipolar I disorder
o
major depressive disorder (MDD) when ABILIFY is used with antidepressant medicines
o
irritability associated with autistic disorder
o
Tourette s disorder
ABILIFY Injectionis a prescription medicine used to treat:
o
agitation associated with schizophrenia or bipolar mania

It Is Not Known If Abilify Is Safe Or Effective In Children: 

under 13 years of age with schizophrenia
under 10 years of age with bipolar I disorder
under 6 years of age with irritability associated with autistic disorder
under 6 years of age with Tourette s disorder

Who Should Not Take Abilify? 

Do not take ABILIFY if youare allergic to aripiprazole or any of the ingredients in ABILIFY.

Before Taking Abilify, 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 ABILIFY 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 ABILIFY will harm your unborn baby.
breast-feeding or plans to breast-feed. ABILIFY 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 ABILIFY.
low white blood cell count.
phenylketonuria. ABILIFY DISCMELT Orally Disintegrating Tablets contain phenylalanine.
any other medical conditions.

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

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

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

Take ABILIFY exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking ABILIFY yourself.
ABILIFY can be taken with or without food.
ABILIFY tablets should be swallowed whole.
If you miss a dose of ABILIFY, 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 ABILIFY at the same time.
If you have been prescribed ABILIFY DISCMELT, take it as follows:
o
Do not open the blister until ready to take the DISCMELT tablet.
o
To remove one DISCMELT tablet, open the package and peel back the foil on the blister to expose the tablet.
o
Do not push the tablet through the foil because this could damage the tablet.
o
Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ABILIFY DISCMELT Orally Disintegrating Tablet on the tongue.
o
Tablet disintegration occurs rapidly in saliva. It is recommended that ABILIFY DISCMELT be taken without liquid. However, if needed, it can be taken with liquid.
o
Do not attempt to split the DISCMELT tablet.
If you take too much ABILIFY, 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 Abilify? 

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

Abilify May Cause Serious Side Effects, Including: 

Store ABILIFY at room temperature, between 68 F to 77 F (20 C to 25 C).

Opened bottles of ABILIFY Oral Solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.

Keep ABILIFY and all medicines out of the reach of children.

General information about the safe and effective use of ABILIFY.

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

This Medication Guide summarizes the most important information about ABILIFY. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ABILIFY that was written for healthcare professionals.

For more information about ABILIFY visit www.abilify.com.

Active Ingredient: 

aripiprazole

Tablets: 

cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake

Abilify Discmelt Orally Disintegrating Tablets: 

acesulfame potassium, aspartame (which contains phenylalanine), calcium silicate, croscarmellose sodium, crospovidone, cr me de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake

Abilify Oral Solution: 

disodium edetate, fructose (200 mg per mL), glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose (400 mg per mL), and purified water. The oral solution is flavored with natural orange cream and other natural flavors

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

Tablets manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan

Orally Disintegrating Tablets, Oral Solution, and Injection manufactured by Bristol-Myers Squibb Company, Princeton, NJ 08543 USA

Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA

ABILIFY is a trademark of Otsuka Pharmaceutical Company.

Otsuka Logo

2016, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan

Revised: January 2016

Discuss The Following Issues With Patients Prescribed Abilify: 

Clinical Worsening of Depression and Suicide Risk

Patients, their families, and their 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 behaviorand indicate a need for very close monitoring and possibly changes in the medication[seeWARNINGS AND PRECAUTIONS (5.3)].

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with ABILIFY 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 ABILIFY. 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 ABILIFY is not approved as a single agent for treatment of depression and has not been evaluated in pediatric major depressive disorder.

Use of Orally Disintegrating Tablet

Do not open the blister until ready to administer. For single tablet removal, open the package and peel back the foil on the blister to expose the tablet. Do not push the tablet through the foil because this could damage the tablet. Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ABILIFY DISCMELT Orally Disintegrating Tablet on the tongue. Tablet disintegration occurs rapidly in saliva. It is recommended that ABILIFY DISCMELT be taken without liquid. However, if needed, it can be taken with liquid. Do not attempt to split the tablet.

Interference with Cognitive and Motor Performance

Because ABILIFY 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 ABILIFY therapy does not affect them adversely[see WARNINGS AND PRECAUTIONS (5.10)].

Nursing

Advise patients that breastfeeding is not recommended with ABILIFY treatment because of the potential for serious adverse reactions in a nursing infant[seeUSE IN SPECIFIC POPULATIONS (8.3)].

Concomitant Medication

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[seeDRUG INTERACTIONS (7)].

Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration[seeWARNINGS AND PRECAUTIONS (5.11)].

Sugar Content

Patients should be advised that each mL of ABILIFY Oral Solution contains 400 mg of sucrose and 200 mg of fructose.

Phenylketonurics

Phenylalanine is a component of aspartame. Each ABILIFY DISCMELT Orally Disintegrating Tablet contains the following amounts: 10 mg, 1.12 mg phenylalanine and 15 mg, 1.68 mg phenylalanine.

Tablets manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan

Orally Disintegrating Tablets, Oral Solution, and Injection manufactured by Bristol-Myers Squibb Company, Princeton, NJ 08543 USA

Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA

ABILIFY is a trademark of Otsuka Pharmaceutical Company.

Otsuka Logo

Rev January 2016

2016, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan

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.

What Else Do I Need To Know About Antidepressant Medicines? 

  • Never stop an antidepressant medicine without first talking to a healthcare provider.Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses.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.

  • Antidepressant medicines have other side effects.Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines.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.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children.Talk to your child s healthcare provider for more information.

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

It should be noted that ABILIFY is approved to be added to an antidepressant when the response from the antidepressant alone is not adequate. ABILIFY is not approved for pediatric patients with depression.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

ABILIFY is a trademark of Otsuka Pharmaceutical Company.

1239550A7 0309L-2745C Rev November 2009

2009, Otsuka Pharmaceutical Co, Ltd, Tokyo, 101-8535 Japan

Repackaged by:Rebel Distributors Corp.

Thousand Oaks, CA 91320



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