ARIPIPRAZOLE solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Amneal Pharmaceuticals LLC

INN (Nama Internasional):

ARIPIPRAZOLE

Komposisi:

ARIPIPRAZOLE 1 mg in 1 mL

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Aripiprazole oral solution is indicated for the treatment of: - Schizophrenia [see Clinical Studies (14.1)] - Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies (14.2)] - Adjunctive Treatment of Major Depressive Disorder [see Clinical Studies (14.3)] - Irritability Associated with Autistic Disorder [see Clinical Studies (14.4)] - Treatment of Tourette’s Disorder [see Clinical Studies (14.5)] Aripiprazole oral solution 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://womensmentalh

Ringkasan produk:

Aripiprazole oral solution (1 mg/mL) is supplied in child-resistant bottles along with a calibrated oral dosing cup. Aripiprazole oral solution is available as follows:             150 mL bottle                         NDC 65162-893-74 Oral Solution Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Opened bottles of aripiprazole oral solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle. The bottle and its contents should be discarded after the expiration date.

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

ARIPIPRAZOLE- ARIPIPRAZOLE SOLUTION
Amneal Pharmaceuticals LLC
----------
MEDICATION GUIDE
Aripiprazole (ar″ i pip′ ra zole) Oral Solution
What is the most important information I should know about
aripiprazole oral solution?
(For other side effects, also see “What are the possible side
effects of aripiprazole oral solution?”)
Serious side effects may happen when you take aripiprazole oral
solution, including:
•
Increased risk of death in elderly patients with dementia-related
psychosis: Medicines like
aripiprazole oral solution can raise the risk of death in elderly
people who have lost touch with
reality (psychosis) due to confusion and memory loss (dementia).
Aripiprazole oral solution 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) 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

Karakteristik produk

ARIPIPRAZOLE- ARIPIPRAZOLE SOLUTION
AMNEAL PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARIPIPRAZOLE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ARIPIPRAZOLE ORAL
SOLUTION.
ARIPIPRAZOLE ORAL SOLUTION
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 ORAL SOLUTION 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 oral solution is an atypical antipsychotic. The oral
formulations are indicated for:
Schizophrenia (14.1)
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I
(14.2)
Adjunctive Treatment of Major Depressive Disorder (14.3)
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
Bipolar mania – adults: monotherapy (2.2)
15 mg/day
15 mg/day
30
mg/day
Bipolar mania – adults: adjunct to lithium or valproate (2.2)
10 mg/day to
15 mg/day
15 mg/day
30
mg/day
Bipolar mania – pediatric patients: monotherapy or as an
adjunct to lithium or valproate (2.2)
2 mg/day
10 mg/day
30
mg/day
Major Depressive Disorder – Adults adjunct to antidepressants
(2.3)
2 mg/day to 5
mg/day
5 mg/day to 10
mg/day
15
mg/day
Irritability associated with autistic disorder �