ARIPIPRAZOLE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

XLCare Pharmaceuticals, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Aripiprazole oral tablets are indicated for the treatment of: - Schizophrenia [see Clinical Studies (14.1)] 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 tablets are 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-p

Dettagli prodotto:

Aripiprazole tablets, USP 2 mg are light green to green, modified rectangular, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘94’ on other side. Bottles of 30 Tablets                                                                 NDC 72865-153-30 Bottles of 500 Tablets                                                               NDC 72865-153-05 Aripiprazole tablets, USP 5 mg are light blue to blue, modified rectangular, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘95’ on other side. Bottles of 30 Tablets                                                               NDC 72865-154-30 Bottles of 500 Tablets                                                             NDC 72865-154-05 Aripiprazole tablets, USP 10 mg are light pink to pink, modified rectangular, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘96’ on other side. Bottles of 30 Tablets                                                                 NDC 72865-155-30 Bottles of 500 Tablets                                                               NDC 72865-155-05 Aripiprazole tablets, USP 15 mg are light yellow to yellow, round, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘97’ on other side. Bottles of 30 Tablets                                                                  NDC 72865-156-30 Bottles of 500 Tablets                                                                NDC 72865-156-05 Aripiprazole tablets, 20 mg are white to off-white, round, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘98’ on other side. Bottles of 30 Tablets                                                                   NDC 72865-157-30 Bottles of 500 Tablets                                                                 NDC 72865-157-05 Aripiprazole tablets, USP 30 mg are light pink to pink, round, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘99’ on other side. Bottles of 30 Tablets                                                                   NDC 72865-158-30 Bottles of 500 Tablets                                                                 NDC 72865-158-05 Store at 20º to 25º C (68º to 77ºF) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
XLCare Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Aripiprazole Tablets, USP
(ar'' i pip' ra zole)
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) 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 following sympt

Scheda tecnica

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
XLCARE 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._
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS
ARE AT AN INCREASED RISK OF DEATH. ARIPIPRAZOLE TABLETS ARE 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 tablets are an atypical antipsychotic. The oral
formulations are indicated for: (1)
(1)
Schizophrenia (14.1)
DOSAGE AND ADMINISTRATION
Initial Dose (2)
Recommended Dose (2)
Maximum Dose (2)
Schizophrenia – adults (2.1) (2)
10 to 15 mg/day (2)
10 to 15 mg/day (2)
30 mg/day (2)
Schizophrenia – adolescents (2.1) (2)
2 mg/day (2)
10 mg/day (2)
30 mg/day (2)
Oral formulations: Administer once daily without regard to meals (2)
Known CYP2D6 poor metabolizers: Half of the usual dose (2.7)
DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to aripiprazole tablets (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)