ABILIFY- aripiprazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

ARIPIPRAZOLE

Composition:

ARIPIPRAZOLE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

ABILIFY ® (aripiprazole) Tablets are pink, rectangle and have A-008 10 on one side. Available in bottles of 30 (NDC 55289-251-30). Tablets Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Oral Solution Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . 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. The bottle and its contents should be discarded after the expiration date. Injection Store at 25ºC (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Protect from light by storing in the original container. Retain in carton until time of use.

Authorization status:

New Drug Application

Patient Information leaflet

PD-Rx Pharmaceuticals, Inc.
----------
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
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 06/2020
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 foll

Summary of Product characteristics

ABILIFY- ARIPIPRAZOLE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
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
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 to 15
mg/day
10 to 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 to 15
mg/day
15 mg/day
30 mg/day
Bipolar mania – pediatric patients: monotherapy or
as an adjunct to lithium or valproate ( 2.2)
2 mg/day
10 mg/day
30 mg/day
Major Depressive Disorder – Adults adjunct to
antidepressants ( 2.3)
2 to 5 mg/day
5 to 10 mg/day
15