ARIPIPRAZOLE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Aripiprazole (UNII: 82VFR53I78) (Aripiprazole - UNII:82VFR53I78)

Commercializzato da:

Ajanta Pharma USA Inc.

INN (Nome Internazionale):

Aripiprazole

Composizione:

Aripiprazole 2 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Aripiprazole Oral Tablets are indicated for the treatment of: - Schizophrenia - Irritability Associated with Autistic Disorder - Treatment of Tourette’s Disorder 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 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://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including aripiprazole, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations) . Overall av

Dettagli prodotto:

Aripiprazole tablets, USP have markings on one side and are available in the strengths and packages listed in Table 32. Tablets Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ARIPIPRAZOLE - ARIPIPRAZOLE TABLET
Ajanta Pharma USA Inc.
----------
MEDICATION GUIDE
Aripiprazole (ar”i pip’ra zole)
Tablets, USP
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?”).
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 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:
•
Antidepressant medicines may increase suicidal thoughts or actions in
some children,
teenagers, and young adults within the first few months of treatment.
•
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.
•
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 your family membe

Scheda tecnica

ARIPIPRAZOLE - ARIPIPRAZOLE TABLET
AJANTA PHARMA USA 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 formulations are
indicated for:
Schizophrenia (14.1)
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 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
Irritability associated with autistic disorder –
pediatric patients (2.4)
2 mg/day
5 to 10 mg/day
15 mg/day
Tourette’s disorder –
(2.5)
Patients <50 kg
2 mg/day
5 mg/day
10 mg/day
Patients ≥50 kg
2 mg/day
10 mg/day
20 mg/day
Oral formulations: Administer once daily without regard to meals (2)
Known CYP2D6 poor metabolizers: Half of the usual dose (2.7)
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 adve