ARIPIPRAZOLE- aripiprazole orally disintegrating tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ScieGen Pharmaceuticals Inc

INN (International Name):

ARIPIPRAZOLE

Composition:

ARIPIPRAZOLE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aripiprazole orally disintegrating tablets are indicated for the treatment of: - Schizophrenia [ see CLINICAL STUDIES ( 14.1) ] - Irritability Associated with Autistic Disorder [see Clinical Studies ( 14.4)] - Treatment of Tourette’s Disorder [see Clinical Studies ( 14.5)] 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) ]. 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

Product summary:

Aripiprazole orally disintegrating tablets, USP are round tablets with markings on either side. Aripiprazole orally disintegrating tablets, USP are available in the strengths and packages listed in Table 33. Tablets Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ARIPIPRAZOLE- ARIPIPRAZOLE ORALLY DISINTEGRATING TABLET
ScieGen Pharmaceuticals Inc
----------
MEDICATION GUIDE
Aripiprazole Orally
Disintegrating Tablets, USP
(ar'' i pip' ra zole)
Read this Medication Guide before you start taking aripiprazole
tablets and each time you get a refill.
There may be new information. This Medication Guide does not take the
place of talking to your
healthcare provider about your medical condition or treatment.
What is the most important information I should know about
aripiprazole orally disintegrating tablets?
(For other side effects, also see “What are the possible side
effects of aripiprazole orally disintegrating
tablets?”).
Serious side effects may happen when you take aripiprazole orally
disintegrating tablets, including:
•
Increased risk of death in elderly patients with dementia-related
psychosis:
Medicines like aripiprazole orally disintegrating 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 orally disintegrating 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) 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 i

Summary of Product characteristics

ARIPIPRAZOLE- ARIPIPRAZOLE ORALLY DISINTEGRATING TABLET
SCIEGEN PHARMACEUTICALS INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARIPIPRAZOLE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS.
ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS
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 (
5.5) 08/2019
INDICATIONS AND USAGE
Aripiprazole is an atypical antipsychotic. The oral formulation is
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 mg/day to 15
mg/day
10 mg/day 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 mg/day 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
Orally Disintegrating Tablets: 10 mg and 15 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity to aripip