ARIPIPRAZOLE- aripiprazole tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Teva Pharmaceuticals USA, Inc.

DCI (Dénomination commune internationale):

ARIPIPRAZOLE

Composition:

ARIPIPRAZOLE 2 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Aripiprazole 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 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 Category C Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. For more information contact 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 to antipsychotic drugs (including aripiprazole) during t

Descriptif du produit:

Aripiprazole tablets USP are available in the strengths and packages listed in Table 32: Table 32: Aripiprazole Tablet USP Presentations Tablet Strength Tablet Color/Shape Tablet Markings Pack Size NDC Code 2 mg Green capsule-shaped “TV” and “7613” Bottle of 30 0093-7613-56 5 mg Blue capsule-shaped “TV” and “7569” Bottle of 30 0093-7569-56 10 mg Pink capsule-shaped “TV” and “7580” Bottle of 30 0093-7580-56 15 mg Yellow flat faced beveled edge round tablet “TV” and “7581” Bottle of 30 0093-7581-56 20 mg White flat faced beveled edge round tablet “TV” and “7582” Bottle of 30 0093-7582-56 30 mg Pink flat faced beveled edge round tablet “TV” and “7583” Bottle of 30 0093-7583-56 Tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Aripiprazole (air-eh-PIP-rah-
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)
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 symptoms,
especially if they are new,

Résumé des caractéristiques du produit

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
TEVA PHARMACEUTICALS USA, 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 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, Pathological Gambling and Other Compulsive
Behaviors (5.7)
08/2016
Warnings and Precautions, Falls (5.9)
02/2017
INDICATIONS AND USAGE
Aripiprazole is an atypical antipsychotic. The oral formulations are
indicated for: (1)
Schizophrenia (14.1)
DOSAGE AND ADMINISTRATION
Initial
Recommended
Maximum
Dose
Dose
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 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 (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 a