ARIPIPRAZOLE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Accord Healthcare, Inc.

ІПН (Міжнародна Ім'я):

ARIPIPRAZOLE

Склад:

ARIPIPRAZOLE 2 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Aripiprazole tablets 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 Aripiprazole tablets are 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 aripiprazole, 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://womensmentalhealth.org/clinical-and-resear

Огляд продуктів:

Aripiprazole tablets, USP have markings on one side an are available in the strengths and packages listed in Table 32. Bottles of 30’s & 100’s count comes with child-resistant package. Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Accord Healthcare, Inc.
----------
MEDICATION GUIDE
ARIPIPRAZOLE TABLETS
(AR-I-PIP-RA-ZOLE)
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 02/2023
What is the most important information I should know about
aripiprazole tablets?
(For other side effects, also see “What are the possible side
effects of aripiprazole tablets?”).
Serious side effects may happen when you take aripiprazole tablets,
including:
•
Increased risk of death in elderly patients with dementia-related
psychosis:
Medicines like aripiprazole tablets can raise the risk of death in
elderly people who have lost touch
with reality (psychosis) due to confusion and memory loss (dementia).
Aripiprazole tablets are 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 visits with the healthcare provider as scheduled.
Call the
healthcare provider between visits as needed, especially if you have
concerns

Характеристики продукта

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
ACCORD HEALTHCARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARIPIPRAZOLE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ARIPIPRAZOLE TABLETS.
ARIPIPRAZOLE TABLETS, FOR ORAL USE
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. Aripiprazole 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)
INDICATIONS AND USAGE
Aripiprazole 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)
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 mg/day
Irritability associated with autistic
disorder – pediatric patients ( 2.4)
2 mg/day
5 to 10 mg/day
15 mg/