QUETIAPINE EXTENDED RELEASE- quetiapine tablet, film coated, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

ACI Healthcare USA, Inc.

INN (Tarptautinis Pavadinimas):

QUETIAPINE FUMARATE

Sudėtis:

QUETIAPINE 150 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 to 17 years) treated with quetiapine tablets [see Clinical Studies (14.1)]. Quetiapine 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 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 associated with bipolar I disorder as wel

Produkto santrauka:

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

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

QUETIAPINE EXTENDED RELEASE- QUETIAPINE TABLET, FILM COATED, EXTENDED
RELEASE
ACI Healthcare USA, Inc.
----------
MEDICATION GUIDE
Quetiapine (kwe-TYE-a-peen) Extended-Release Tablets
Read this Medication Guide before you start taking quetiapine
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
extended-release tablets?
Quetiapine extended-release tablets may cause serious side effects,
including:
1. risk of death in the elderly with dementia: Medicines like
quetiapine extended-release tablets can
increase the risk of death in elderly people who have memory loss
(dementia). Quetiapine 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, thoughts, or
feelings. This is very important when an antidepress

Prekės savybės

QUETIAPINE EXTENDED RELEASE- QUETIAPINE TABLET, FILM COATED, EXTENDED
RELEASE
ACI HEALTHCARE USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
QUETIAPINE EXTENDED-RELEASE
TABLETS.QUETIAPINE 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 EXTENDED-RELEASE TABLETS ARE 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, Tardive Dyskinesia (5.6) 08/2019
INDICATIONS AND USAGE
Quetiapine extended-release tablets are 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. (2.3, 8.5)
_Hepatic Impairment_: Lower starting dose (50 mg/day) and slower
titration may be needed (2.4, 8.7, 12.3)
Indication
Initial Dose
Recommended
Dose
M