ARIPIPRAZOLE tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Limited

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)] 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)]. 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 an

Product summary:

Aripiprazole Orally Disintegrating Tablets are round tablets with markings on one side and plain on other side. Aripiprazole Orally Disintegrating Tablet is available in the strengths and packages listed in Table 14. Table 14: Aripiprazole Orally Disintegrating Tablets Presentations Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ARIPIPRAZOLE - ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING
Alembic Pharmaceuticals Limited
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MEDICATION GUIDE
Aripiprazole (AR-i-PIP-ra-zole )
Orally Disintegrating Tablets
Read this Medication Guide before you start taking aripiprazole 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?
(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) 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 foll

Summary of Product characteristics

ARIPIPRAZOLE - ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING
ALEMBIC PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AROPIPRAZOLE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARIPIPRAZOLE.
ARIPIPRAZOLE ORALLY DISINTEGRATING 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. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Metabolic Changes (5.6) 12/2014
INDICATIONS AND USAGE
Aripiprazole is an atypical antipsychotic indicated as oral
formulations for the: (1)
Schizophrenia (14.1)
DOSAGE AND ADMINISTRATION
Initial Dose Recommended DoseMaximum 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 formulations: Administer once daily without regard to meals
(2)
•Known CYP2D6 poor metabolizers: Half of the usual dose (2.7) (2)
DOSAGE FORMS AND STRENGTHS
Orally Disintegrating Tablets: 10 mg and 15 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 (5.3)
_Tardive