QUETIAPINE FUMARATE tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Preferred Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

QUETIAPINE FUMARATE

Composição:

QUETIAPINE 200 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies (14.2)] . Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, a

Resumo do produto:

200 mg Tablets (NDC 16729-148) white to off white, round, biconvex, film coated tablet, debossed ‘200’ on one side and plain on other side, are supplied as follow: Bottle of 30 - 68788-9487-3 Bottle of 60 - 68788-9487-6 Bottle of 90 - 68788-9487-9 Bottle of 100 - 68788-9487-1 Bottle of 120 - 68788-9487-8 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP].

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

QUETIAPINE FUMARATE- quetiapine fumarate tablet, film coated
Preferred Pharmaceuticals, Inc.
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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
changes in

Características técnicas

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
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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
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
SUICIDAL THOUGHTS AND BEHAVIORS
RECENT MAJOR CHANGES
9/2020
INDICATIONS AND USAGE
Quetiapine tablet is an atypical antipsychotic indicated for the
treatment of:
•
•
•
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
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
25 mg twice daily
400 to 600 mg/day
600 mg/day
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS;
and SUICIDAL THOUGHTS AND BEHAVIORS
_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. QUETIAPINE IS NOT APPROVED FOR
ELDERLY PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS ( 5.1)
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)
Warnings and Precautions ( 5.20)
Schizophrenia ( 1.1)
Bipolar I disorder manic episodes ( 1.2)
Bipolar disorder, depressive episodes ( 1.2)
Schizophrenia-
Adolescents (13 to
17 years) ( 2.2 )
and Adolescents (10 to 17
years), Monotherapy (
2.2)
Bipolar Depression-Adults
( 2.2)
50 mg once daily at
bedtime
300 mg/day
300 mg/day
•
•
DOSAGE FORMS AND STRENGT