ARIPIPRAZOLE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Proficient Rx LP

INN (इंटरनेशनल नाम):

ARIPIPRAZOLE

रचना:

ARIPIPRAZOLE 2 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Aripiprazole Oral Tablets are indicated for the treatment of: Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. 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 Category C Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs (including aripiprazole) during the third trimester of pregnancy

उत्पाद समीक्षा:

Aripiprazole tablets, USP, 2 mg, are supplied as green to light green colored, mosaic appearance, modified rectangle shaped, uncoated tablet with debossing “AN896” and “2” on one side and plain on the other side. They are available as follows: Bottles of 30:                          NDC 63187-965-30 Bottles of 60:                          NDC 63187-965-60 Bottles of 90:                         NDC 63187-965-90 Tablets Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] in tightly closed containers. 

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
Proficient Rx LP
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MEDICATION GUIDE
Aripiprazole (AR-i-PIP-ra-zole) Tablets, USP
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 about
symptoms.
Call a healthcare provider right away if you or yo

उत्पाद विशेषताएं

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
PROFICIENT RX LP
----------
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._
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Pathological Gambling and Other Compulsive
Behaviors (5.7) 08/2016
INDICATIONS AND USAGE
Aripiprazole tablets are an atypical antipsychotic. The oral
formulations are indicated for:
•
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
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
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)
Schizophrenia (14.1)
Oral formulations: Administer once daily without regard to meals (2)
Known CYP2D6 poor metabolizers: Half of the usual dose (2.7)
Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (3)
Known hypersensitivity to aripiprazole (4)
_Cerebrovascular Adverse Reactions in Elderly Patients with
Dementia-Related Psychosis:_ Increased incidence of
cerebrovascular adverse reactions (e.g., stroke, transient ischemic
attack, including fatalities) (5.2)
_Neuroleptic Malignant Syndrome:_ Manage with immediate
discontinuation and close m