ARIPIPRAZOLE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Major Pharmaceuticals

INN (nemzetközi neve):

ARIPIPRAZOLE

Összetétel:

ARIPIPRAZOLE 2 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Aripiprazole Oral Tablets are indicated for the treatment of: Aripiprazole 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://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including aripiprazole, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery

Termék összefoglaló:

Aripiprazole tablets, USP 5 mg are white to off-white, round, uncoated tablets, debossed with "5" on one side and "17" on other side.        500 tablets per bottle, NDC 0904-6656-40 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].

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

Major Pharmaceuticals
----------
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:
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 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 your family member has
any of the foll

Termékjellemzők

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
MAJOR PHARMACEUTICALS
----------
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 ( 5.5) 08/2019
INDICATIONS AND USAGE
Aripiprazole Oral Tablets are indicated for the treatment of:
•
•
•
•
•
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
2 mg/day
10 mg/day
30 mg/day
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)
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)
monotherapy or as an adjunct to
lithium or valproate ( 2.2)
Major Depressive Disorder –
Adults adjunct to antidepressants
( 2.3)
2 to 5 mg/day
5 to 10 mg/day
15 mg/day
Irritab