Subscribe Facebook Twitter Instagram
Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

ARIPIPRAZOLE solution


  1. Discuss The Following Issues With Patients Prescribed Aripiprazole Oral Solution:
  2. Increased Risk Of Death In Elderly Patients With Dementia-related Psychosis:
  3. Risk Of Suicidal Thoughts Or Actions:
  4. How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions In Myself Or A Family Member?
  5. What Is Aripiprazole Oral Solution?
  6. Inactive Ingredients:
  7. Patient Information
  8. Aripiprazole:
  9. Aripiprazole Oral Solution?
  10. 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:
  11. What Else Do I Need To Know About Antidepressant Medicines?
  12. Is A Prescription Medicine Used To Treat:
  13. It Is Not Known If Aripiprazole Oral Solution Is Safe Or Effective In Children:
  14. May Cause Serious Side Effects, Including:
  15. Problems With Your Metabolism Such As:
  16. Aripiprazole Oral Solution:
  17. Active Ingredient:
  18. Oral Solution:
  19. What Is The Most Important Information I Should Know About Aripiprazole Oral Solution?
  20. Aripiprazole Oral Solution Is A Prescription Medicine Used To Treat:
  21. What Should I Avoid While Taking Aripiprazole Oral Solution?
  22. Aripiprazole Oral Solution May Cause Serious Side Effects, Including:
  23. Distributed By:

Discuss The Following Issues With Patients Prescribed Aripiprazole Oral Solution: ⮝

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[

(For other side effects, also ).

Increased Risk Of Death In Elderly Patients With Dementia-related Psychosis: ⮝

Medicines like aripiprazole oral solution can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole oral solution is not approved for the treatment of patients with dementia-related psychosis.

Risk Of Suicidal Thoughts Or Actions: ⮝

Antidepressant medicines, depression and other serious mental illnesses, and 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. 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.

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 Is Aripiprazole Oral Solution? ⮝

Aripiprazoleoral solution

Inactive Ingredients: ⮝

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

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

All registered trademarks are the property of their respective owners.

APOTEX INC.
ARIPIPRAZOLE ORAL SOLUTION
1mg/mL

Manufactured byManufactured for
Apotex Inc.Apotex Corp.
Toronto, OntarioWeston, Florida
Canada M9L 1T933326

Revised: August 2019

Patient Information ⮝

Advise the patient to read the FDA-approved patient labeling(Medication Guide).

Discuss the following issues with patients prescribed

Aripiprazole: ⮝

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 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 is not approved as a single agent for treatment of depression and has not been evaluated in pediatric major depressive disorder.

Pathological Gambling and Other Compulsive Behaviors

Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking aripiprazole. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped[seeWarnings and Precautions (5.7)].

Interference with Cognitive and Motor Performance

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[seeWarnings and Precautions (5.12)].

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 (5.13)].

Sugar Content

Patients should be advised that each mL of aripiprazole oral solution contains 400 mg of sucrose and 200 mg of fructose.

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with aripiprazole. Advise patients that aripiprazole may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy[seeUse in Specific Populations (8.1)].

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 09-2019-14

Aripiprazole Oral Solution? ⮝

(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 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.

What is

Is A Prescription Medicine Used To Treat: ⮝

  • Schizophrenia
  • manic or mixed episodes that happen with bipolar I disorder
  • major depressive disorder (MDD) when aripiprazole oral solution is used with antidepressant medicines
  • irritability associated with autistic disorder
  • Tourette s disorder

It Is Not Known If Aripiprazole Oral Solution 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

Do not take aripiprazole oral solutionif youare allergic to aripiprazole or any of the ingredients in aripiprazole oral solution.

  • Take aripiprazole oral solution exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking aripiprazole oral solution yourself.
  • Aripiprazole oral solution can be taken with or without food.
  • If you miss a dose of aripiprazole oral solution, 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 oral solution at the same time.
  • If you take too much aripiprazole oral solution, 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

May Cause Serious Side Effects, Including: ⮝

  • 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 oral solution 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 oral solution. Tardive dyskinesia may also start after you stop receiving aripiprazole oral solution.

Problems With Your Metabolism Such As: ⮝

  • High blood sugar (hyperglycemia) and diabetes.Increases in blood sugar can happen in some people who take aripiprazole oral solution. 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 oral solution and during your treatment.

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

Aripiprazole Oral Solution: ⮝

  • 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.
    • Weight gain.You and your healthcare provider should check your weight regularly.
  • Unusual urges.Some people taking aripiprazole oral solution 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.

    • Store aripiprazole oral solution at room temperature, between 68 F to 77 F (20 C to 25 C).
    • Opened bottles of aripiprazole oral solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.

    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

Active Ingredient: ⮝

aripiprazole, USP

Oral Solution: ⮝

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

For more information about aripiprazole oral solution visit www.amneal.com.

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

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 09-2019-11

What Is The Most Important Information I Should Know About Aripiprazole Oral Solution? ⮝


(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.

Aripiprazole Oral Solution Is A Prescription Medicine Used To Treat: ⮝

  • Schizophrenia
  • manic or mixed episodes that happen with bipolar I disorder

What Should I Avoid While Taking Aripiprazole Oral Solution? ⮝

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

Aripiprazole Oral Solution May Cause Serious Side Effects, Including: ⮝


    • Store aripiprazole oral solution at room temperature, between 20 to 25 C (68 to 77 F).
    • Opened bottles of aripiprazole oral solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.

    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

Distributed By: ⮝


ATLANTIC BIOLOGICALS CORP.

20101 NE 16TH PLACE

MIAMI, FL 33179

Ad
Ad

Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources | Sitemap
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: phq.contact@gmail.com