ARIPIPRAZOLE solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Apotex Corp.

INN (Nome Internazionale):

ARIPIPRAZOLE

Composizione:

ARIPIPRAZOLE 1 mg in 1 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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://wom

Dettagli prodotto:

Aripiprazole Oral Solution (1 mg/mL) is supplied in a 150 mL amber PET metric round bottle with a white polypropylene child-resistant cap with induction seal liner along with a calibrated oral dosing cup. Aripiprazole oral solution is available as follows: Oral Solution Store at 20°C to 25°C (68°F to 77°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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ARIPIPRAZOLE- ARIPIPRAZOLE SOLUTION
Apotex Corp.
----------
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 healthcare p

Scheda tecnica

ARIPIPRAZOLE- ARIPIPRAZOLE SOLUTION
APOTEX CORP.
----------
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 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 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)
10-15
mg/day
10-15 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)
10-15
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)
2-5
mg/day
5-10 mg/day
15 mg/day
Irritability associated
with autistic disorder –
2 mg/day
5-10 mg/day
15 mg/day
with autistic disorder –
pediatric patients
(2.4)
2 mg/day
5