QUETIAPINE FUMARATE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Bryant Ranch Prepack

INN (Mezinárodní Name):

QUETIAPINE FUMARATE

Složení:

QUETIAPINE 200 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Quetiapine tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)]. Quetiapine tablet is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see Clinical Studies (14.

Přehled produktů:

NDC: 63629-4964-1: 30 Tablets in a BOTTLE NDC: 63629-4964-2: 100 Tablets in a BOTTLE NDC: 63629-4964-3: 120 Tablets in a BOTTLE NDC: 63629-4964-4: 90 Tablets in a BOTTLE NDC: 63629-4964-5: 60 Tablets in a BOTTLE

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
Bryant Ranch Prepack
----------
Medication Guide
Quetiapine Tablets
(kwe-TYE-a-peen)
Read this Medication Guide before you start taking quetiapine tablets
and each time you get a refill.
There may be new information. This information does not take the place
of talking to your healthcare
provider about your medical condition or your treatment.
What is the most important information I should know about quetiapine
tablets?
Quetiapine tablets may cause serious side effects, including:
1. risk of death in the elderly with dementia: Medicines like
quetiapine tablets can increase the risk of
death in elderly people who have memory loss (dementia). Quetiapine
tablet 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:
•
all risks and benefits of treatment with antidepressant medicines.
•
all treatment choices for depression or other serious mental illness.
•
Antidepressant medications 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 antidepressant
medicine is started or
when the dose is changed.
•
Call the healthcare provider right away to report new or sudden
ch

Charakteristika produktu

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
QUETIAPINE TABLETS.
QUETIAPINE 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 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)
INDICATIONS AND USAGE
Quetiapine tablet is an atypical antipsychotic indicated for the
treatment of:
Schizophrenia ( 1.1)
Bipolar I disorder manic episodes ( 1.2)
Bipolar disorder, depressive episodes ( 1.2)
DOSAGE AND ADMINISTRATION
Quetiapine tablets can be taken with or without food ( 2.1).
INDICATION
INITIAL DOSE
RECOMMENDED
DOSE
MAXIMUM
DOSE
Schizophrenia-Adults ( 2.2)
25 mg twice daily
150 to 750
mg/day
750
mg/day
Schizophrenia-Adolescents (13 to 17 years) ( 2.2)
25 mg twice daily
400 to 800
mg/day
800
mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to
lithium or divalproex ( 2.2)
50 mg twice daily
400 to 800
mg/day
800
mg/day
Bipolar Mania- Children and Adolescents (10 to 17
years), Monotherapy ( 2.2)
25 mg twice daily
400 to 600
mg/day
600
mg/day
Bipolar Depression-Adults ( 2.2)
50 mg once daily at
bedtime
300 mg/day
300
mg/day
_Geriatric Use:_ Consider a lower starting dose (50 mg/day), slower
titration and careful monitoring during
the initial dosing period in the eld