ABILIFY- aripiprazole tablet ABILIFY- aripiprazole solution ABILIFY- aripiprazole tablet, orally disintegrating ABILIFY- arip

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Otsuka America Pharmaceutical, Inc.

INN (International Name):

ARIPIPRAZOLE

Composition:

ARIPIPRAZOLE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ABILIFY (aripiprazole) Oral Tablets, Orally-Disintegrating Tablets, and Oral Solution are indicated for the treatment of: - Schizophrenia - Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder - Adjunctive Treatment of Major Depressive Disorder - Irritability Associated with Autistic Disorder - Treatment of Tourette's Disorder ABILIFY Injection is indicated for the treatment of: - Agitation associated with schizophrenia or bipolar mania 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 providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhea

Product summary:

ABILIFY® (aripiprazole) Tablets have markings on one side an are available in the strengths and packages listed in Table 32. 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 33. 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] . 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

ABILIFY- ARIPIPRAZOLE SOLUTION
ABILIFY- ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING
ABILIFY- ARIPIPRAZOLE INJECTION, SOLUTION
Otsuka America Pharmaceutical, 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: 08/2019
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.
•
Cal

Summary of Product characteristics

ABILIFY - TABLET
ABILIFY - SOLUTION
ABILIFY - TABLET, ORALLY DISINTEGRATING
ABILIFY - INJECTION, SOLUTION
OTSUKA AMERICA PHARMACEUTICAL, INC. * HUMAN PRESCRIPTION DRUG LABEL
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT
DRUGS
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
[see Warnings and Precautions (5.1)].
Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents, and young adults in short-term studies.
These studies did not show an increase in the risk of suicidal
thoughts and behavior with antidepressant use in patients over age 24
years; there was a reduction in risk with antidepressant use in
patients aged 65 years and older [see Warnings and Precautions (5.3)].
In patients of all ages who are started on antidepressant therapy,
monitor closely for worsening, and for emergence of suicidal thoughts
and behaviors. Advise families and caregivers of the need for close
observation and communication with the prescriber [see Warnings and
Precautions (5.3)].
INDEX * 1. INDICATIONS AND USAGE * 2. DOSAGE AND ADMINISTRATION * 3. DOSAGE FORMS AND STRENGTHS * 4. CONTRAINDICATIONS * 5. WARNINGS AND PRECAUTIONS * 6. ADVERSE REACTIONS * 7. DRUG INTERACTIONS * 8. USE IN SPECIFIC POPULATIONS * 9. DRUG ABUSE AND DEPENDENCE * 10. OVERDOSAGE * 11. DESCRIPTION * 12. CLINICAL PHARMACOLOGY * 13. NONCLINICAL TOXICOLOGY * 14. CLINICAL STUDIES * 15. HOW SUPPLIED/STORAGE AND HANDLING * 16. PATIENT COUNSELING INFORMATION * 17. DISTRIBUTED BY * 18. SPL MEDGUIDE * 19. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL * 20. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL * 21. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL * 22. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL * 23. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL * 24. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL * 25. PACKAGE/LABEL PRINCIPAL DISPLAY P