ABILIFY- aripiprazole tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)

Beschikbaar vanaf:

Bryant Ranch Prepack

INN (Algemene Internationale Benaming):

ARIPIPRAZOLE

Samenstelling:

ARIPIPRAZOLE 5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

ABILIFY Oral Tablets, Orally-Disintegrating Tablets, and Oral Solution are indicated for the treatment of: - Schizophrenia [see Clinical Studies (14.1)] - Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies (14.2)] - Adjunctive Treatment of Major Depressive Disorder [see Clinical Studies (14.3)] - Irritability Associated with Autistic Disorder [see Clinical Studies (14.4)] - Treatment of Tourette's Disorder [see Clinical Studies (14.5)] ABILIFY Injection is indicated for the treatment of: - Agitation associated with schizophrenia or bipolar mania [see Clinical Studies (14.6)] ABILIFY is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see Adverse Reactions (6.2)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including ABILIFY, during pregnancy. Healthcare pro

Product samenvatting:

Product: 63629-3387 NDC: 63629-3387-1 30 TABLET in a BOTTLE NDC: 63629-3387-2 60 TABLET in a BOTTLE NDC: 63629-3387-3 90 TABLET in a BOTTLE NDC: 63629-3387-4 180 TABLET in a BOTTLE

Autorisatie-status:

New Drug Application

Bijsluiter

Bryant Ranch Prepack
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 08/2019
MEDICATION GUIDE
ABILIFY ® (a BIL ĭ fī)
(aripiprazole)
Tablets
ABILIFY ® (a BIL ĭ fī)
(aripiprazole)
Orally Disintegrating Tablets
ABILIFY ® (a BIL ĭ fī)
(aripiprazole)
Oral Solution
ABILIFY ® (a BIL ĭ fī)
(aripiprazole)
Injection, for
intramuscular use
What is the most important information I should know about ABILIFY?
(For other side effects, also see " What are the possible side effects
of ABILIFY? ")
Serious side effects may happen when you take ABILIFY, including:
•
Increased risk of death in elderly patients with dementia-related
psychosis: Medicines like ABILIFY
can raise the risk of death in elderly people who have lost touch with
reality (psychosis) due to
confusion and memory loss (dementia). ABILIFY 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:
•
Antidepressant medicines may increase suicidal thoughts or actions in
some children,
teenagers, and young adults within the first few months of treatment.
•
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

Productkenmerken

ABILIFY- ARIPIPRAZOLE TABLET
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABILIFY SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ABILIFY.
ABILIFY (ARIPIPRAZOLE) TABLETS
ABILIFY DISCMELT (ARIPIPRAZOLE) ORALLY DISINTEGRATING TABLETS
ABILIFY (ARIPIPRAZOLE) ORAL SOLUTION
ABILIFY (ARIPIPRAZOLE) INJECTION FOR INTRAMUSCULAR USE ONLY
INITIAL U.S. APPROVAL: 2002
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT
DRUGS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED
RISK OF DEATH. ABILIFY IS NOT APPROVED FOR THE TREATMENT OF PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS. (
5.1)
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS. MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL
THOUGHTS AND BEHAVIORS. ( 5.3)
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.5)
08/2019
INDICATIONS AND USAGE
ABILIFY is an atypical antipsychotic. The oral formulations are
indicated for:
Schizophrenia ( 14.1)
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I
( 14.2)
Adjunctive Treatment of Major Depressive Disorder ( 14.3)
Irritability Associated with Autistic Disorder ( 14.4)
Treatment of Tourette's disorder ( 14.5)
The injection is indicated for:
Agitation associated with schizophrenia or bipolar mania ( 14.6)
DOSAGE AND ADMINISTRATION
INITIAL DOSE
RECOMMENDED DOSE
MAXIMUM DOSE
Schizophrenia – adults ( 2.1)
10-15 mg/day
10-15 mg/day
30 mg/day
Schizophrenia – adolescents
( 2.1)
2 mg/day
10 mg/day
30 mg/day
Bipolar mania – adults: monotherapy ( 2.2)
15 mg/day
15 mg/day
30 mg/day
Bipolar mania – adults: adjunct to lithium or valproate ( 2.2)
10-15 mg/day
15 mg/day
30 mg/day
Bipolar mania – pediatric patients: monotherapy or as an
adjunct to lithium or valpr