ARIPIPRAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Solco Healthcare U.S., LLC

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: 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)] . 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) . Overall available data from published epidemiologic studies of pregnant women exposed to aripiprazole have not est

Product summary:

Aripiprazole tablets, USP have markings and are available in the strengths and packages listed in Table 32. 2 mg Bottle of 30 43547-302-03 white to off-white “2” on one side and Bottle of 90 43547-302-09 capsule-shaped “P” on the other side Bottle of 100 43547-302-10 Bottle of 500 43547-302-50 5 mg Bottle of 30 43547-303-03 pink “5” on one side and Bottle of 90 43547-303-09 capsule-shaped “P” on the other side Bottle of 100 43547-303-10 Bottle of 500 43547-303-50 10 mg Bottle of 30 43547-304-03 beige “10” on one side and Bottle of 90 43547-304-09 capsule-shaped “P” on the other side Bottle of 100 43547-304-10 Bottle of 500 43547-304-50 15 mg Bottle of 30 43547-305-03 pink “15” on one side and Bottle of 90 43547-305-09 round “P” on the other side Bottle of 100 43547-305-10 Bottle of 500 43547-305-50 20 mg Bottle of 30 43547-306-03 beige “20” on one side and Bottle of 90 43547-306-09 round “P” on the other side Bottle of 100 43547-306-10 Bottle of 500 43547-306-50 30 mg Bottle of 30 43547-307-03 white to off-white “30” on one side and Bottle of 90 43547-307-09 round “P” on the other side Bottle of 100 43547-307-10 Bottle of 500 43547-307-50 Tablets Store at 20o C to 25o C (68o F to 77o F); excursions permitted between 15o C to 30o C (59o F to 86o F) [see USP Controlled Room Temperature] .

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Solco Healthcare U.S., LLC
----------
MEDICATION GUIDE
MEDICATION GUIDE
Aripiprazole Tablets, USP
(air-eh-PIP-rah-zole)
Dispense with Medication Guide available at:
www.solcohealthcare.com/medguide/aripiprazole-
tablets.pdf
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 neede

Summary of Product characteristics

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
SOLCO HEALTHCARE U.S., 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._
•
•
INDICATIONS AND USAGE
Aripiprazole is an atypical antipsychotic. The oral formulation is
indicated for:
•
•
•
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
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
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)
Schizophrenia (14.1)
Irritability Associated with Autistic Disorder (14.4)
Treatment of Tourette’s disorder (14.5)
Oral formulation: 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 aripiprazole (4)
_Cerebrovascular Adverse Reactions in Elderly Patients with
Dementia-Related Psychosis: