QUETIAPINE FUMARATE tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Proficient Rx LP

DCI (Dénomination commune internationale):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 50 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Quetiapine fumarate tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate 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 fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see Clinical Studies (14.1)] Quetiapine fumarate 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)] . Quetiapine fumarate tablet is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine fumarate tablets as monotherapy for the maintenance treatment of bipolar disord

Descriptif du produit:

Quetiapine fumarate tablets are available as: 50 mg Tablets (NDC 63187-219) white to off white, round, biconvex, film coated tablet, debossed '50' on one side and plain on other side, are supplied in bottles of 30, 60 and 90 tablets. (NDC 63187-219-30), 60 tablets (NDC 63187-299-60) and 90 tablets (63187-219-90). 100 mg Tablets (NDC 63187-269) yellow coloured, round, biconvex, film coated tablet, debossed ‘100’ on one side and ‘Q’ on other side, are supplied in bottles of 30, 60 and 90 tablets. (NDC 63187-269-30), 60 tablets (NDC 63187-269-60) and 90 tablets (NDC 63187-269-90). Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP].

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
Proficient Rx LP
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MEDGUIDE SECTION
Medication Guide
Quetiapine Fumarate Tablets
Read this Medication Guide before you start taking quetiapine fumarate
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
fumarate tablets?
Quetiapine fumarate tablets may cause serious side effects, including:
1. risk of death in the elderly with dementia: Medicines like
quetiapine fumarate tablets can increase the risk
of death in elderly people who have memory loss (dementia). Quetiapine
fumarate 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.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especially if they are new, worse, or worry you:
thoughts about suicide or dying
attempts to commit suicide
new or worse depression
new or worse anxiety
feeling very agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?
Never stop an antidepressant medicine without first talking to your
healthcare provider. Stopping an
antidep

Résumé des caractéristiques du produit

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
PROFICIENT RX LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE FUMARATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
QUETIAPINE FUMARATE
TABLETS.
QUETIAPINE FUMARATE 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
Warnings and Precautions, Cerebrovascular Adverse Reactions, Including
Stroke, in Elderly Patients with
Dementia-Related Psychosis (ERROR! HYPERLINK REFERENCE NOT VALID.)
4/2013
INDICATIONS AND USAGE
Quetiapine fumarate tablet is an atypical antipsychotic indicated for
the treatment of:
•
•
•
DOSAGE AND ADMINISTRATION
Quetiapine fumarate 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
50 mg twice daily
400 to 800 mg/day
800 mg/day
25 mg twice daily
400 to 600 mg/day
600 mg/day
50 mg once daily at
bedtime
300 mg/day
300 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)
Schizophrenia (1.1)
Bipolar I disorder manic episodes ( 1.2 )
Bipolar disorder, depressive episodes ( 1.2 )
Schizophrenia-Adolescents
(13 to 17 years) ( 2.2 )
Bipolar Mania- Adults
Monotherapy or as an
adjunct to lithium or
divalproex ( 2.