QUETIAPINE FUMARATE- 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:

Safecor Health, LLC

DCI (Dénomination commune internationale):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 25 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Quetiapine fumarate tablets are 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 tablets are 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 fumarate tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week mo

Descriptif du produit:

Quetiapine Fumarate Tablets, 25 mg are peach, round, biconvex, film-coated tablets debossed with ‘E 52’ on one side and plain on the other side.       Boxes of 100 Unit Dose Robot-Rx®1 Tablets                                  NDC 48433-324-01 For Institutional Use Only The product contained in this package is from NDC# 16714-375 Northstar Rx, LLC Memphis, TN Packaged and Distributed by: Safecor Health, LLC 317 New Boston Street Woburn, MA 01801 Safecor Health, LLC 4060 Business Park Drive Columbus, OH 43204 Questions or Comments? Call 1-800-447-1006 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [see USP Controlled Room Temperature]. Rev: 324-00 08/2014

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
Safecor Health, LLC
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MEDICATION GUIDE
Quetiapine Fumarate Tablets
[Quetiapine Fumarate (kwe-TYE-a-peen FUE-ma-rate)]
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 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 wh

Résumé des caractéristiques du produit

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
SAFECOR HEALTH, LLC
----------
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
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
•
SUICIDAL THOUGHTS AND BEHAVIORS
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Cerebrovascular Adverse Reactions, Including
Stroke, in Elderly Patients with Dementia-
Related Psychosis (5.3) 4/2013
INDICATIONS AND USAGE
Quetiapine fumarate tablets are an atypical antipsychotic indicated
for the treatment of:
•
•
•
DOSAGE AND ADMINISTRATION
• INDICATION
INITIAL DOSE
RECOMMENDED DOSE
MAXIMUM
DOSE
Schizophrenia-Adults (2.2)
25 mg twice
daily
150 to 750 mg/day
750 mg/day
Schizophre nia-
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
50 mg once
daily at
300 mg/day
300 mg/day
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH. QUETIAPINE FUMARATE 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 epis