ARIPIPRAZOLE - aripiprazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Trigen Laboratories, LLC

INN (International Name):

ARIPIPRAZOLE

Composition:

ARIPIPRAZOLE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aripiprazole is 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)]. 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 (includi

Product summary:

Aripiprazole Tablets, USP have markings on one side and are available in the strengths and packages listed in Table 14. Table 14: Aripiprazole Tablet, USP Presentations   Tablets Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Trigen Laboratories, LLC
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MEDICATION GUIDE
Aripiprazole (AR-i-PIP-ra-zole )
Tablets, USP
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
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 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, worse, or worry you:
•thoughts abou

Summary of Product characteristics

ARIPIPRAZOLE - ARIPIPRAZOLE TABLET
TRIGEN LABORATORIES, LLC
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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
WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED
PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIOURS 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 indicated as oral
formulations for the:
•Schizophrenia (14.1) (1)
DOSAGE AND ADMINISTRATION
(2)
Initial DoseRecommended 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 formulations: Administer once daily without regard to meals
(2)
•Known CYP2D6 poor metabolizers: Half of the usual dose (2.7) (2)
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 immediat