ARIPIPRAZOLE- aripiprazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

ARIPIPRAZOLE

Composition:

ARIPIPRAZOLE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 (i

Product summary:

Aripiprazole Tablets USP 2 mg are green colored, modified rectangular shaped, uncoated tablets debossed with ‘61’ on one side and ‘H’ on other side.             Bottles of 30                           NDC 65862-661-30             Bottles of 100                         NDC 65862-661-01             Bottles of 500                         NDC 65862-661-05             10 x 10 Unit-dose Tablets      NDC 65862-661-78  Aripiprazole Tablets USP 5 mg are blue colored, modified rectangular shaped, uncoated tablets debossed with ‘62’ on one side and ‘H’ on other side.             Bottles of 30                           NDC 65862-662-30             Bottles of 100                         NDC 65862-662-01             Bottles of 500                         NDC 65862-662-05             10 x 10 Unit-dose Tablets      NDC 65862-662-78 Aripiprazole Tablets USP 10 mg are white colored, modified rectangular shaped, uncoated tablets debossed with ‘63’ on one side and ‘H’ on other side.             Bottles of 30                           NDC 65862-663-30             Bottles of 100                         NDC 65862-663-01             Bottles of 500                         NDC 65862-663-05             10 x 10 Unit-dose Tablets      NDC 65862-663-78  Aripiprazole Tablets USP 15 mg are white colored, round shaped, uncoated tablets debossed with ‘64’ on one side and ‘H’ on other side.             Bottles of 30                           NDC 65862-664-30             Bottles of 100                         NDC 65862-664-01             Bottles of 500                         NDC 65862-664-05             10 x 10 Unit-dose Tablets      NDC 65862-664-78  Aripiprazole Tablets USP 20 mg are white colored, round shaped, uncoated tablets debossed with ‘65’ on one side and ‘H’ on other side.             Bottles of 30                           NDC 65862-665-30             Bottles of 100                         NDC 65862-665-01             Bottles of 500                         NDC 65862-665-05             10 x 10 Unit-dose Tablets      NDC 65862-665-78  Aripiprazole Tablets USP 30 mg are white colored, round shaped, uncoated tablets debossed with ‘66’ on one side and ‘H’ on other side.             Bottles of 30                           NDC 65862-666-30             Bottles of 100                         NDC 65862-666-01             Bottles of 500                         NDC 65862-666-05             10 x 10 Unit-dose Tablets      NDC 65862-666-78 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
REMEDYREPACK 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 symptoms,
especi

Summary of Product characteristics

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
REMEDYREPACK 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 formulation is
indicated for:
Schizophrenia (14.1)
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
Oral formulation: 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 cl