ARIPIPRAZOLE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Preferred Pharmaceuticals Inc.

INN (International Adı):

ARIPIPRAZOLE

Kompozisyon:

ARIPIPRAZOLE 2 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 (see Clinical Considerations) . Overall available data from published epidemiologic studies of pregnant women exposed to aripiprazole have not est

Ürün özeti:

Aripiprazole tablets, USP 2 mg are yellow, round, uncoated tablets with scattered specks, debossed with "2" on one side and "16" on other side. Bottles of 20                           NDC 68788-7076-2 Bottles of 30                           NDC 68788-7076-3 Bottles of 60                           NDC 68788-7076-6 Bottles of 90                           NDC 68788-7076-9 Bottles of 100                           NDC 68788-7076-1 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].

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Preferred Pharmaceuticals Inc.
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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

Ürün özellikleri

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
PREFERRED PHARMACEUTICALS 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._
•
•
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 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/day
Tourette's
disorder – (2.5)
Patients ˂ 50 kg 2 mg/day
5 mg/day
10 mg/day
Patients ≥ 50
kg
2 mg/day
10 mg/day
20 mg/day
•
•
DOSAGE FORMS AND STRENGTHS
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)
Acu