ARIPIPRAZOLE tablet, orally disintegrating

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Bionpharma Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Aripiprazole orally disintegrating tablets are indicated for the treatment of: - Schizophrenia  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 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 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-research-programs/pregnancyregistry/. Risk Summary Neonates exposed t

Podsumowanie produktu:

Aripiprazole orally disintegrating tablets, USP are round tablets with markings on either side. Aripiprazole orally disintegrating tablets, USP are available in the strengths and packages listed in Table 33. Bottle of 30s NDC 69452-338-13 Bottle of 30s NDC 69452-339-13 Store at 20° to 25°C (68° to 77°F); excursions permitted within 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING
Bionpharma Inc.
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MEDICATION GUIDE
Aripiprazole (air-eh-PIP-rah-zole) Orally Disintegrating Tablets, USP
What is the most important information I should know about
aripiprazole orally disintegrating tablets?
(For other side effects, also see “What are the possible side
effects of aripiprazole orally disintegrating
tablets?”).
Serious side effects may happen when you take aripiprazole orally
disintegrating tablets, including:
•
Increased risk of death in elderly patients with dementia-related
psychosis: Medicines like
aripiprazole orally disintegrating 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 orally
disintegrating 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 schedu

Charakterystyka produktu

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING
BIONPHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARIPIPRAZOLE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS.
ARIPIPRAZOLE ORALLY DISINTEGRATING 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 orally disintegrating tablets are an atypical
antipsychotic. The oral formulations are indicated
for: (1)
Schizophrenia (14.1) (1)
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
Oral formulation: Administer once daily without regard to meals (2)
Known CYP2D6 poor metabolizers: Half of the usual dose (2.7)
DOSAGE FORMS AND STRENGTHS
Orally Disintegrating Tablets: 10 mg and 15 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to aripiprazole (4)
WARNINGS AND PRECAUTIONS
_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 monitoring (5.4)
_Tardive Dyskinesia:_ Disconti