ARIPIPRAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

ARIPIPRAZOLE

Composition:

ARIPIPRAZOLE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aripiprazole Oral Tablets are indicated for the treatment of: - Schizophrenia - Irritability Associated with Autistic Disorder - Treatment of Tourette’s Disorder 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 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including aripiprazole, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations) .

Product summary:

Aripiprazole tablets USP, 2 mg, are supplied as green to light green colored, mosaic appearance, modified rectangle shaped, uncoated tablet with debossing “AN896” and “2” on one side and plain on the other side. They are available as follows: Bottles of 30:                          NDC 65162-896-03 Bottles of 90:                          NDC 65162-896-09 Bottles of 500:                        NDC 65162-896-50 Bottles of 1000:                      NDC 65162-896-11 Aripiprazole tablets USP, 5 mg, are supplied as blue to light blue colored, mosaic appearance, modified rectangle shaped, uncoated tablet with debossing “AN897” and “5” on one side and plain on the other side. They are available as follows: Bottles of 30:                          NDC 65162-897-03 Bottles of 90:                          NDC 65162-897-09 Bottles of 500:                        NDC 65162-897-50 Bottles of 1000:                      NDC 65162-897-11 Aripiprazole tablets USP, 10 mg, are supplied as pink to light pink colored, mosaic appearance, modified rectangle shaped, uncoated tablet with debossing “AN898” and “10” on one side and plain on the other side. They are available as follows: Bottles of 30:                          NDC 65162-898-03 Bottles of 90:                          NDC 65162-898-09 Bottles of 500:                        NDC 65162-898-50 Bottles of 1000:                      NDC 65162-898-11 Aripiprazole tablets USP, 15 mg, are supplied as yellow to light yellow colored, mosaic appearance, round shaped, uncoated tablet with debossing “AN899” and “15” on one side and plain on the other side. They are available as follows: Bottles of 30:                          NDC 65162-899-03 Bottles of 90:                          NDC 65162-899-09 Bottles of 500:                        NDC 65162-899-50 Bottles of 1000:                      NDC 65162-899-11 Aripiprazole tablets USP, 20 mg, are supplied as white to off-white, round shaped, uncoated tablet with debossing “AN901” and “20” on one side and plain on the other side. They are available as follows: Bottles of 30:                          NDC 65162-901-03 Bottles of 90:                          NDC 65162-901-09 Bottles of 500:                        NDC 65162-901-50 Bottles of 1000:                      NDC 65162-901-11 Aripiprazole tablets USP, 30 mg, are supplied as pink to light pink colored, mosaic appearance, round shaped, uncoated tablet with debossing “AN902” and “30” on one side and plain on the other side. They are available as follows: Bottles of 30:                          NDC 65162-902-03 Bottles of 90:                          NDC 65162-902-09 Bottles of 500:                        NDC 65162-902-50 Bottles of 1000:                      NDC 65162-902-11 Tablets Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] in tightly closed containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Amneal Pharmaceuticals LLC
----------
MEDICATION GUIDE
Aripiprazole (ar” i pip’ ra 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:
•
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers,
and young adults within the first few months of treatment.
•
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.
•
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

Summary of Product characteristics

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
AMNEAL PHARMACEUTICALS 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._
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
formulations are indicated for:
Schizophrenia. (14.1)
Irritability Associated with Autistic Disorder. (14.4)
Treatment of Tourette’s disorder. (14.5)
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
Irritability associated with autistic disorder – pediatric
patients (2.4)
2 mg/day
5 to 10 mg/day
15 mg/day
Tourette’s disorder – (2.5)
Patients <50 kg
2 mg/day
5 mg/day
10 mg/day
Patients ≥50 kg
2 mg/day
10 mg/day
20 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