QUETIAPINE FUMARATE EXTENDED-RELEASE- quetiapine fumarate tablet, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

SpecGx LLC

INN (Tarptautinis Pavadinimas):

QUETIAPINE FUMARATE

Sudėtis:

QUETIAPINE 50 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Quetiapine Fumarate Extended-release Tablets USP is indicated for the treatment of schizophrenia. The efficacy of Quetiapine Fumarate Extended-release Tablets USP 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 USP is 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 USP 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

Produkto santrauka:

 Store Quetiapine Fumarate Extended-Release Tablets USP at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP Controlled Room Temperature].

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

QUETIAPINE FUMARATE EXTENDED-RELEASE- QUETIAPINE FUMARATE TABLET,
EXTENDED
RELEASE
SpecGx LLC
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MEDICATION GUIDE
Quetiapine Fumarate
(kwe tye´ a peen fue´ ma rate)
Extended-Release Tablets USP
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 is 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:
o all risks and benefits of treatment with antidepressant medicines
o 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?
o Pay close attention to any changes, especially sudden changes, in
mood, behaviors, though

Prekės savybės

QUETIAPINE FUMARATE EXTENDED-RELEASE- QUETIAPINE FUMARATE TABLET,
EXTENDED
RELEASE
SPECGX LLC
----------
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
•ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH. QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS
IS NOT APPROVED FOR ELDERLY
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1)
SUICIDAL THOUGHTS AND BEHAVIORS
•INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS. (5.2)
•MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS. (5.2)
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 Extended-release Tablets USP is an atypical
antipsychotic indicated for the treatment of:
Schizophrenia (1.1)
Bipolar I disorder, manic or mixed episodes (1.2)
Bipolar disorder, depressive episodes (1.2)
Major depressive disorder, adjunctive therapy with antidepressants
(1.3)
DOSAGE AND ADMINISTRATION
Swallow tablets whole and do not split, chew or crush (2.1)
Take without food or with a light meal (approx. 300 calories) (2.1)
Administer once daily, preferably in the evening (2.1)
_Geriatric Use: _Consider a lower starting dose (50 mg/day), slower
titration, and careful monitoring during the initial
dosing period in the elderly. (