ARIPIPRAZOLE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Bryant Ranch Prepack

INN (Jina la Kimataifa):

ARIPIPRAZOLE

Tungo:

ARIPIPRAZOLE 5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Aripiprazole Oral Tablets are indicated for the treatment of: - Schizophrenia [see Clinical Studies ( 14.1) ] - Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies ( 14.2) ] - Adjunctive Treatment of Major Depressive Disorder [see Clinical Studies ( 14.3) ] - Irritability Associated with Autistic Disorder [see Clinical Studies (

Bidhaa muhtasari:

NDC: 63629-6999-1: 30 Tablets in a BOTTLE NDC: 63629-6999-2: 28 Tablets in a BOTTLE NDC: 63629-6999-3: 90 Tablets in a BOTTLE NDC: 63629-6999-4: 60 Tablets in a BOTTLE NDC: 63629-6999-5: 120 Tablets in a BOTTLE NDC: 63629-6999-6: 15 Tablets in a BOTTLE

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

Bryant Ranch Prepack
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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:
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 follo

Tabia za bidhaa

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
BRYANT RANCH PREPACK
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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 )
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.5) 08/2019
INDICATIONS AND USAGE
Aripiprazole Oral Tablets are indicated for the treatment of:
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
2 mg/day
5 to 10 mg/day
15 mg/