ARIPIPRAZOLE tablet, orally disintegrating

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Viona Pharmaceuticals Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Aripiprazole orally disintegrating tablets are indicated for the treatment of: - Schizophrenia [see Clinical Studies (14.1)] - Irritability Associated with Autistic Disorder [see Clinical Studies (14.4) ] - Treatment of Tourette's Disorder [see Clinical Studies (14.5)] 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-researchprograms/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including aripiprazole, during the third trimester of pregnancy are at risk

Огляд продуктів:

Aripiprazole Orally Disintegrating Tablets USP, 10 mg are white to off-white, capsule-shaped, uncoated tablets debossed with 'ZF 41' on one side and plain on the other side and are supplied as follows: NDC 72578-106-06 in bottle of 30 tablets NDC 72578-106-78 in carton pack of 30 tablets (3x10's blister pack) Aripiprazole Orally Disintegrating Tablets USP, 15 mg are white to off-white, round-shaped, biconvex, uncoated tablets debossed with 'ZF 42' on one side and plain on other side and are supplied as follows: NDC 72578-107-06 in bottle of 30 tablets NDC 72578-107-78 in carton pack of 30 tablets (3x10's blister pack) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Viona Pharmaceuticals Inc.
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MEDICATION GUIDE
Aripiprazole (ar" i pip' ra 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:
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
n

Характеристики продукта

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING
VIONA PHARMACEUTICALS 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
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 is an atypical antipsychotic. The oral formulation is
indicated for:
Schizophrenia (14.1)
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
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
Orally Disintegrating Tablets: 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 Patie