ABILIFY- aripiprazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

ARIPIPRAZOLE

Composition:

ARIPIPRAZOLE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY was established in four 4-6 week trials in adults and one 6-week trial in adolescents (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents [see CLINICAL STUDIES (14.1)] . Acute Treatment of Manic and Mixed Episodes ABILIFY is indicated for the acute treatment of manic and mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate. Efficacy as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in pediatric patients (10 to 17 years). Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults [see CLINICAL STUDIES (14.2)] . Maintenance Treatment of Bipolar I Disorder ABILIFY is indicated for the maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to either lithium or valproate. Maintenance efficacy was

Product summary:

ABILIFY® (aripiprazole) Tablets have markings on one side and are available in the strengths and packages listed in Table 15. ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets are round tablets with markings on either side. ABILIFY DISCMELT is available in the strengths and packages listed in Table 16. ABILIFY® (aripiprazole) Oral Solution (1 mg/mL) is supplied in child-resistant bottles along with a calibrated oral dosing cup. ABILIFY Oral Solution is available as follows: ABILIFY® (aripiprazole) Injection for intramuscular use is available as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) solution in clear, Type 1 glass vials as follows: 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].

Authorization status:

New Drug Application

Patient Information leaflet

ABILIFY - ARIPIPRAZOLE TABLET
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
ABILIFY® (a BIL ĭ fī)
Generic name: aripiprazole
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 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:
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.
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 wi

Summary of Product characteristics

ABILIFY - ARIPIPRAZOLE TABLET
PHYSICIANS TOTAL CARE, 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
ABILIFY DISCMELT (ARIPIPRAZOLE) ORALLY DISINTEGRATING TABLETS
ABILIFY (ARIPIPRAZOLE) ORAL SOLUTION
ABILIFY (ARIPIPRAZOLE) INJECTION FOR INTRAMUSCULAR USE ONLY
INITIAL U.S. APPROVAL: 2002
WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED
PSYCHOSIS AND SUICIDALITY AND 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)
CHILDREN, ADOLESCENTS, AND YOUNG ADULTS TAKING ANTIDEPRESSANTS FOR
MAJOR DEPRESSIVE DISORDER (MDD)
AND OTHER PSYCHIATRIC DISORDERS ARE AT INCREASED RISK OF SUICIDAL
THINKING AND BEHAVIOR. (5.2)
RECENT MAJOR CHANGES
Indications and Usage, Bipolar I Disorder,
Adjunctive Therapy (1.2) 02/2011
Dosage and Administration, Bipolar I Disorder,
Adjunctive Therapy (2.2) 02/2011
Dosage and Administration, Dosage Adjustment (2.6) 02/2011
INDICATIONS AND USAGE
ABILIFY is an atypical antipsychotic indicated
as oral formulations for the:
Treatment of schizophrenia (1.1)
Adults: Efficacy was established in four 4-6 week trials and one
maintenance trial in patients with schizophrenia (14.1)
Adolescents (ages 13-17): Efficacy was established in one 6-week trial
in patients with schizophrenia (14.1)
Acute treatment of manic or mixed episodes associated with bipolar I
disorder as monotherapy and as an adjunct to lithium
or valproate (1.2)
Adults: Efficacy was established in four 3-week monotherapy trials and
one 6-week adjunctive trial in patients with
manic or mixed episodes (14.2)
Pediatric Patients (ages 10-17): Efficacy was established in one
4-week monotherapy trial in patients w