ARIPIPRAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, 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)] . 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 o

Product summary:

Aripiprazole tablets, USP 2 mg are available for oral administration as green, rectangular, slightly biconvex tablets, engraved "2" on one side and "A" on the other side. Bottles of 30 (NDC 60429-446-30) Aripiprazole tablets, USP 5 mg are available for oral administration as blue, rectangular, slightly biconvex tablets, engraved “5” on one side and “A” on the other side. Bottles of 30 (NDC 60429-447-30) Aripiprazole tablets, USP 10 mg are available for oral administration as pink, rectangular, slightly biconvex tablets, engraved “10” on one side and “A” on the other side. Bottles of 30 (NDC 60429-448-30) Aripiprazole tablets, USP 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. Bottles of 30 (NDC 60429-449-30) Aripiprazole tablets, USP 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. Bottles of 30 (NDC 60429-450-30) Aripiprazole tablets, USP 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. Bottles of 30 (NDC 60429-451-30) Tablets Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
Golden State Medical Supply, Inc.
----------
MEDICATION GUIDE
Aripiprazole Tablets, USP
(ar-i-pip-ra-zole)
Medication Guide available at www1.apotex.com/products/us
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 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

Summary of Product characteristics

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
ARIPIPRAZOLE TABLETS. 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)
INDICATIONS AND USAGE
Aripiprazole tablets are 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 15mg/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 and close monitoring (5.4)
_Tardive Dyskinesia: _Discontinue if clinically appropriate (5.5)
_Metabolic Changes:_ Atypical antips