ARIPIPRAZOLE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Aripiprazole (UNII: 82VFR53I78) (Aripiprazole - UNII:82VFR53I78)

Dostupno od:

Safecor Health, LLC

INN (International ime):

Aripiprazole

Sastav:

Aripiprazole 2 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Aripiprazole Oral Tablets are indicated for the treatment of: 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)] . Teratogenic Effects 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 the third trim

Proizvod sažetak:

Aripiprazole tablets 2 mg are available for oral administration as green, rectangular, slightly biconvex tablets, engraved "2" on one side and "A" on the other side. Aripiprazole tablets 5 mg are available for oral administration as blue, rectangular, slightly biconvex tablets, engraved “5” on one side and “A” on the other side. Aripiprazole tablets 10 mg are available for oral administration as pink, rectangular, slightly biconvex tablets, engraved “10” on one side and “A” on the other side. Aripiprazole tablets 15 mg are available for oral administration as yellow, round, slightly biconvex tablets, engraved “ARI” over “15” on one side and “APO” on the other side. Aripiprazole tablets 20 mg are available for oral administration as white to off-white, round, slightly biconvex tablets, engraved “ARI” over “20” on one side and “APO” on the other side. Aripiprazole tablets 30 mg are available for oral administration as pink, round, slightly biconvex tablets, engraved “ARI” over “30” on one side and “APO” on the other side. Tablets Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

ARIPIPRAZOLE- aripiprazole tablet
Safecor Health, LLC
----------
MEDICATION GUIDE
Aripiprazole Tablets
(ar-i-pip-ra-zole)
Read this Medication Guide before you start taking aripiprazole
tablets and each time you get a refill. There
may be new information. This Medication Guide does not take the place
of talking to your healthcare
provider about your medical condition or treatment.
What is the most important information I should know about
aripiprazole?
(For other side effects, also see “What are the possible side
effects of aripiprazole?”).
Serious side effects may happen when you take aripiprazole, including:
Increased risk of death in elderly patients with dementia-related
psychosis: Medicines like aripiprazole
can raise the risk of death in elderly people who have lost touch with
reality (psychosis) due to
confusion and memory loss (dementia). Aripiprazole is 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 follo

Svojstava lijeka

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
SAFECOR HEALTH, LLC
----------
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._
1.
2.
RECENT MAJOR CHANGES
Warnings and Precautions, Metabolic Changes (5.6) 12/2014
INDICATIONS AND USAGE
Aripiprazole tablets are an atypical antipsychotic. The oral
formulation is indicated for:
1.
2.
DOSAGE AND ADMINISTRATION
Initial
Dose
Recommended
Dose
Maximum
Dose
Schizophrenia – adults (2.1)
10-15
mg/day
10-15 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)
10-15
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
1.
2.
DOSAGE FORMS AND STRENGTHS
1.
CONTRAINDICATIONS
1.
WARNINGS AND PRECAUTIONS
1.
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. (5.2)
Schizophrenia (14.1)
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I
(14.2)
Oral formulations: Administer once daily without regard to meals (2)
Known CYP2D6 poor metabolizers: Half of the usual dose (2.7)
Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (3)
Known hypersensitivity to