QUETIAPINE FUMARATE EXTENDED RELEASE- quetiapine fumarate tablet, extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)

Tersedia dari:

Par Pharmaceutical Inc.

INN (Nama Internasional):

QUETIAPINE FUMARATE

Komposisi:

QUETIAPINE 200 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Quetiapine fumarate extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with quetiapine fumarate tablets [see Clinical Studies (14.1)]. Quetiapine fumarate extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of quetiapine fumarate extended-release tablets in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes

Ringkasan produk:

Store quetiapine fumarate extended-release tablets at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [See USP Controlled Room Temperature].

Status otorisasi:

New Drug Application Authorized Generic

Selebaran informasi

QUETIAPINE FUMARATE EXTENDED RELEASE- QUETIAPINE FUMARATE TABLET,
EXTENDED RELEASE
Par Pharmaceutical Inc.
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MEDICATION GUIDE
Quetiapine Fumarate (kweh-TIE-ah-peen)
Extended-Release Tablets
Read this Medication Guide before you start taking quetiapine fumarate
extended-release tablets and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking to your healthcare provider about your medical condition or
treatment.
What is the most important information I should know about quetiapine
fumarate extended-release tablets?
Quetiapine fumarate extended-release tablets may cause serious side
effects, including:
1. risk of death in the elderly with dementia: Medicines like
quetiapine fumarate extended-release
tablets can increase the risk of death in elderly people who have
memory loss (dementia). Quetiapine
fumarate extended-release tablets are not for treating psychosis in
the elderly with dementia.
2. risk of suicidal thoughts or actions (antidepressant medicines,
depression and other serious mental
illnesses, and suicidal thoughts or actions).
Talk to your or your family member’s, healthcare provider about:
∘
all risks and benefits of treatment with antidepressant medicines
∘
all treatment choices for depression or other serious mental illness
•
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) depression,
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, thoug

Karakteristik produk

QUETIAPINE FUMARATE EXTENDED RELEASE- QUETIAPINE FUMARATE TABLET,
EXTENDED
RELEASE
PAR PHARMACEUTICAL INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE FUMARATE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR QUETIAPINE FUMARATE
EXTENDED-RELEASE TABLETS.
QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
•
SUICIDAL THOUGHTS AND BEHAVIORS
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Leukopenia, Neutropenia and Agranulocytosis
(5.10) 11/2018
Warnings and Precautions, Anticholinergic (antimuscarinic) Effects
(5.20) 11/2018
INDICATIONS AND USAGE
Quetiapine fumarate is an atypical antipsychotic indicated for the
treatment of:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
INDIC ATIO N
I NITIAL
DO SE
RECO MMENDED
DO SE
MAXIMUM
DO SE
Schizophrenia - Adults (2.2)
300 mg/day 400-800 mg/day
800 mg/day
Schizophrenia - Adolescents (13 to 17 years) (2.2)
50 mg/day
400-800 mg/day
800 mg/day
Bipolar I Disorder manic or mixed - Acute monotherapy or adjunct to
lithium or divalproex-Adults (2.2)
300 mg/day 400-800 mg/day
800 mg/day
Bipolar I Disorder, manic Acute monotherapy - Children and
Adolescents (10 to 17 years) (2.2)
50 mg/day
400-600 mg/day
600 mg/day
Bipolar Disorder, Depressive Episodes - Adults (2.2)
50 mg/day
300 mg/day
300 mg/day
Major Depressive Disorder, Adjunctive Therapy with Antidepressants -
50 mg/day
150-300 mg/day
300 mg/day
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH. QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS
ARE NOT APPROVED FOR ELDERLY
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1)
INCREASED RISK OF SUICI