QUETIAPINE 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:

Teva Pharmaceuticals USA, Inc.

DCI (Denominação Comum Internacional):

QUETIAPINE FUMARATE

Composição:

QUETIAPINE 25 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)] . Quetiapine 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 (14.2)] . Quetiapine 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 Stud

Resumo do produto:

Quetiapine Tablets, USP are available as follows: 25 mg – light orange, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “V7” on the other side, in bottles of 100 (NDC 0093-2063-01). 50 mg – white to off-white, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8166” on the other side, in bottles of 100 (NDC 0093-8166-01). 100 mg – light orange, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8162” on the other side, in bottles of 100 (NDC 0093-8162-01). 200 mg – white to off-white, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8163” on the other side, in bottles of 100 (NDC 0093-8163-01). 300 mg – pale yellow, capsule-shaped, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8164” on the other side, in bottles of 100 (NDC 0093-8164-01). 400 mg – white to off-white, capsule-shaped, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8165” on the other side, in bottles of 100 (NDC 0093-8165-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

QUETIAPINE- QUETIAPINE TABLET, FILM COATED
Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Quetiapine (kwe tye’ a peen)
Tablets
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
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 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

Características técnicas

QUETIAPINE- QUETIAPINE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
----------
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 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 elderly (2.3, 8.5)
_Hepatic Impa