ARIPIPRAZOLE- aripiprazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

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: - 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) ]. 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 antipsychotic drugs (including aripiprazole) d

Product summary:

Aripiprazole Tablets, USP have markings on one side and are available in the strengths and packages listed in Table 32. 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 TABLET
REMEDYREPACK INC.
---------- MEDICATION GUIDE
Aripiprazole Tablets, USP
(ar'' i pip' ra zole)
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:
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 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 y

Summary of Product characteristics

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
REMEDYREPACK INC.
----------
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 is an atypical antipsychotic. The oral formulation is
indicated for:
Schizophrenia ( 14.1)
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
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)
_Neuroleptic Malignant Syndrome: _Manage with immediate
discontinuation and close monitoring ( 5.4)
_Tardive Dyskinesia: _Discontinue if clinically appropriate ( 5.5)
_Metabolic Changes:_ Atypical antipsychotic drugs have been associated
with metabolic changes that include
hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain (
5.6)
_Hy