ARIPIPRAZOLE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Macleods Pharmaceuticals Limited

INN (Kansainvälinen yleisnimi):

ARIPIPRAZOLE

Koostumus:

ARIPIPRAZOLE 2 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Aripiprazole Oral Tablets are indicated for the treatment of: • Schizophrenia •  Irritability Associated with Autistic Disorder (14.4) • Treatment of Tourette’s disorder (14.5) 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 C

Tuoteyhteenveto:

Aripiprazole tablets, USP have markings on one side and are available in the strengths and packages listed in Table 32: Table 32: Aripiprazole Tablet, USP Presentations Tablets Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

ARIPIPRAZOLE - ARIPIPRAZOLE TABLET
Macleods Pharmaceuticals Limited
----------
SPL MEDGUIDE SECTION
MEDICATION GUIDE
Aripiprazole Tablets
(a-ri-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, 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:
• 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) 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 member has
any of the f

Valmisteyhteenveto

ARIPIPRAZOLE - ARIPIPRAZOLE TABLET
MACLEODS PHARMACEUTICALS LIMITED
----------
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
Patients ≥50 kg
2 mg/day
10 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
CONTRAINDICATIONS
• Known hypersensitivity to aripiprazole (4)
WARNINGS AND PRECAUTIONS
• _Cerebrovascular Adverse Reactions in Elderly Patients with
Dementia-Related Psych