ARIPIPRAZOLE- aripiprazole tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Aripiprazole Oral Tablets are 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 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 Category C Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/.

Tóm tắt sản phẩm:

Aripiprazole tablets, USP 2 mg are yellow, round, uncoated tablets with scattered specks, debossed with "2" on one side and "16" on other side. Bottles of 30                           NDC 13668-216-30 Bottles of 90                           NDC 13668-216-90 Bottles of 100                         NDC 13668-216-01 Bottles of 500                         NDC 13668-216-05 Bottles of 6250                       NDC 13668-216-69 100 Unit dose Tablets            NDC 13668-216-74 Aripiprazole tablets, USP 5 mg are white to off-white, round, uncoated tablets, debossed with "5" on one side and "17" on other side.                        Bottles of 30                           NDC 13668-217-30 Bottles of 90                           NDC 13668-217-90 Bottles of 100                         NDC 13668-217-01 Bottles of 500                         NDC 13668-217-05 Bottles of 6250                       NDC 13668-217-69 100 Unit dose Tablets            NDC 13668-217-74 Aripiprazole tablets, USP 10 mg are white to off-white, round, uncoated tablets, debossed with "10" on one side and "18" on other side. Bottles of 30                           NDC 13668-218-30 Bottles of 90                           NDC 13668-218-90 Bottles of 100                         NDC 13668-218-01 Bottles of 500                         NDC 13668-218-05 Bottles of 7000                       NDC 13668-218-52 100 Unit dose Tablets            NDC 13668-218-74 Aripiprazole tablets, USP 15 mg are white to off-white, round, uncoated tablets, debossed with "15" on one side and "19" on other side.                         Bottles of 30                           NDC 13668-219-30 Bottles of 90                           NDC 13668-219-90 Bottles of 100                         NDC 13668-219-01 Bottles of 500                         NDC 13668-219-05 Bottles of 5000                       NDC 13668-219-51 100 Unit dose Tablets            NDC 13668-219-74 Aripiprazole tablets, USP 20 mg are white to off-white, round, uncoated tablets, debossed with "20" on both sides. Bottles of 30                           NDC 13668-220-30 Bottles of 90                           NDC 13668-220-90 Bottles of 100                         NDC 13668-220-01 Bottles of 500                         NDC 13668-220-05 Bottles of 3400                       NDC 13668-220-68 100 Unit dose Tablets            NDC 13668-220-74 Aripiprazole tablets, USP 30 mg are white to off-white, round, uncoated tablets, debossed with "30" on one side and "21" on other side. Bottles of 30                           NDC 13668-221-30 Bottles of 90                           NDC 13668-221-90 Bottles of 100                         NDC 13668-221-01 Bottles of 500                         NDC 13668-221-05 Bottles of 2500                       NDC 13668-221-31          100 Unit dose Tablets            NDC 13668-221-74 Tablets Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
----------
SPL MEDGUIDE
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 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 symptoms.
Call a heal

Đặc tính sản phẩm

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
DENTON PHARMA, INC. DBA NORTHWIND 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
WARNINGS: 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 )
RECENT MAJOR CHANGES
Warnings and Precautions, Pathological Gambling and Other Compulsive
Behaviors (5.7) 08/2016
Warnings and Precautions, Falls (5.9) 02/2017
INDICATIONS AND USAGE
Anagrelide is a platelet reducing agent indicated for the treatment of
thrombocythemia, secondary to myeloproliferative
neoplasms, to reduce the elevated platelet count and the risk of
thrombosis and to ameliorate associated symptoms
including thrombo-hemorrhagic events. (1) (1)
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 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
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