ARIPIPRAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Carilion Materials Management

INN (International Name):

ARIPIPRAZOLE

Composition:

ARIPIPRAZOLE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aripiprazole is 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 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/. Neonates exposed to antipsychotic drugs (including aripiprazole) duri

Product summary:

NDC:68151-4459-8 in a CUP of 1 TABLETS Aripiprazole Tablets have markings on one side and are available in the strengths and packages listed in Table 14. Table 14: Aripiprazole Tablet 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]. Tablets

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Carilion Materials Management
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MEDICATION GUIDE
Aripiprazole (AR-i-PIP-ra-zole ) 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:
• 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. •
Antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions:
Increased risk of death in elderly patients
with dementia-related psychosis:
Risk of 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. These include people who have (or have a family history of)
suicidal thoughts or actions. 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.
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 provide

Summary of Product characteristics

ARIPIPRAZOLE - ARIPIPRAZOLE TABLET
CARILION MATERIALS MANAGEMENT
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARIPIPRAZOLE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ARIPIPRAZOLE. ARIPIPRAZOLE TABLETS, FOR
ORAL USE. INITIAL U.S. APPROVAL : 2002
WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED
PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIOURS 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 Cnhages (5.6) 12/2014
INDICATIONS AND USAGE
Aripiprazole is an atypical antipsychotic indicated as oral
formulations for the: •Schizophrenia (14.1)
(1)
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
•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
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)
Manage with immediate discontinuation and close monitoring (5.3)
_Neuroleptic Malignant Syndrome:_
Discontinue if clinically appropriate (5.4) _Tardive