ARIPIPRAZOLE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Major Pharmaceuticals

DCI (Denominação Comum Internacional):

ARIPIPRAZOLE

Composição:

ARIPIPRAZOLE 2 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Aripiprazole tablets are indicated for the treatment of: 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 tablets are 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

Resumo do produto:

Aripiprazole Tablets, USP 2 mg are available for oral administration as green, rectangular, slightly biconvex tablets, engraved "2" on one side and "A" on the other side. Carton of 30 (10 tablets each blister pack x 3) NDC 0904-6509-04 Aripiprazole Tablets, USP 5 mg are available for oral administration as blue, rectangular, slightly biconvex tablets, engraved “5” on one side and “A” on the other side. Carton of 100 (10 tablets each blister pack x 10) NDC 0904-6510-61 Carton of 50 (10 tablets each blister pack x 5) NDC 0904-6510-06 Aripiprazole Tablets, USP 10 mg are available for oral administration as pink, rectangular, slightly biconvex tablets, engraved “10” on one side and “A” on the other side. Carton of 100 (10 tablets each blister pack x 10) NDC 0904-6511-61 Carton of 50 (10 tablets each blister pack x 5) NDC 0904-6511-06 Aripiprazole Tablets, USP 15 mg are available for oral administration as yellow, round, slightly biconvex tablets, engraved “ARI” over “15” on one side and “APO” on the other side. Carton of 30 (10 tablets each blister pack x 3) NDC 0904-6512-04 Aripiprazole Tablets, USP 20 mg are available for oral administration as white to off-white, round, slightly biconvex tablets, engraved “ARI” over “20” on one side and “APO” on the other side. Carton of 30 (10 tablets each blister pack x 3) NDC 0904-6513-04 Aripiprazole Tablets, USP 30 mg are available for oral administration as pink, round, slightly biconvex tablets, engraved “ARI” over “30” on one side and “APO” on the other side. Carton of 30 (10 tablets each blister pack x 3) NDC 0904-6514-04 Tablets Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
Major Pharmaceuticals
----------
MEDICATION GUIDE
Aripiprazole Tablets, USP
(ar-i-pip-ra-zole)
Medication Guide available at www1.apotex.com/products/us
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 symp

Características técnicas

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
MAJOR PHARMACEUTICALS
----------
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._
3.
4.
INDICATIONS AND USAGE
Aripiprazole tablets are an atypical antipsychotic. The oral
formulation is indicated for:
4.
5.
6.
DOSAGE AND ADMINISTRATION
Initial Dose
Recommended Dose Maximum Dose
Schizophrenia – adults (2.1)
10 to 15mg/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
15mg/day
Tourette’s disorder
– (2.5)
Patients < 50 kg
2 mg/day
5 mg/day
10mg/day
Patients ≥ 50 kg
2 mg/day
10 mg/day
20mg/day
3.
4.
DOSAGE FORMS AND STRENGTHS
2.
CONTRAINDICATIONS
2.
WARNINGS AND PRECAUTIONS
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
ADVERSE REACTIONS
COMMONLY OBSERVED ADVERSE REACTIONS (INCIDENCE ≥5% AND AT LEAST
TWICE THAT FOR PLACEBO)
WERE (6.1):
5.
6.
7.
8.
DRUG INTERACTIONS
_Dosage adjustment due to drug interactions (7.1):_
FACTORS
DOSAGE ADJUSTMENTS FOR ARIPIPRAZOLE
Known CYP2D6 Poor Metabolizers
Administer half of usual dose
Known CYP2D6 Poor Metabolizers and strong CYP3A4
inhibitors
Administer a quarter of usual dose
Strong CYP2D6 or CYP3A4 inhibitors
Administer half of usual dose
Strong CYP2D6 and CYP3A4inhibitors
Administer a quarter of usual dose
Strong CYP3A4 inducers
Double usual dose over 1 to 2 weeks
USE IN SPECIFIC POPULATIONS
2.
ADDITIONAL PEDIATRIC USE INFORMATION IS APPROVED FOR OTSUKA AMERICA
PHARMACEUTICAL, INC.’S ABILIFY (ARIPIPRAZOLE) PRODUCT. HOWEVER, DUE
TO OTSUKA AMERICA
PHARMACEUTICAL, INC.’S MARKETIN