QUETIAPINE FUMARATE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

NuCare Pharmaceuticals, Inc.

INN (Международно Name):

QUETIAPINE FUMARATE

Композиция:

QUETIAPINE 25 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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) ]. Quetiapineis 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 adul

Каталог на резюме:

Quetiapine tablets, USP 25 mg Peach coloured, film coated, round shape, biconvex tablets, debossed with "262 ” on one side and plain on other side. Bottles of 30 tablets NDC 68071-1892-3 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP].

Статус Оторизация:

Abbreviated New Drug Application

Листовка

QUETIAPINE FUMARATE- quetiapine fumarate tablet
NuCare Pharmaceuticals, Inc.
----------
17 PATIENT COUNSELING
INFORMATION
See FDA-approved patient labeling (Medication Guide)
Prescribers or other health professionals should inform patients,
their families, and their caregivers about the
benefits and risks associated with treatment with quetiapine and
should counsel them in its appropriate use. A
patient Medication Guide about “Antidepressant Medicines, Depression
and other Serious Mental Illness,
and Suicidal Thoughts or Actions” is available for quetiapine. The
prescriber or health professional should
instruct patients, their families, and their caregivers to read the
Medication Guide and should assist them in
understanding its contents. Patients should be given the opportunity
to discuss the contents of the Medication
Guide and to obtain answers to any questions they may have. The
complete text of the Medication Guide is
reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert
their prescriber if these occur while
taking quetiapine.
Increased Mortality in Elderly Patients with Dementia-Related
Psychosis Patients and caregivers should be
advised that elderly patients with dementia-related psychosis treated
with atypical antipsychotic drugs are at
increased risk of death compared with placebo. Quetiapine is not
approved for elderly patients with
dementia-related psychosis [see Warnings and Precautions (5.1)] .
Suicidal Thoughts and Behaviors
Patients, their families, and their caregivers should be encouraged to
be alert to the emergence of anxiety,
agitation, panic attacks, insomnia, irritability, hostility,
aggressiveness, impulsivity, akathisia (psychomotor
restlessness), hypomania, mania, other unusual changes in behavior,
worsening of depression, and suicidal
ideation, especially early during antidepressant treatment and when
the dose is adjusted up or down. Families
and caregivers of patients should be advised to look for the emergence
of such symptoms

Данни за продукта

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
NUCARE PHARMACEUTICALS, 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: INCREASEDMORTALITYINELDERLYPATIENTS WITHDEMENTIA-
RELATEDPSYCHOSIS;ANDSUICIDAL THOUGHTSANDBEHAVIORS
_SEEFULLPRESCRIBING INFORMATIONFORCOMPLETEBOXEDWARNING._
_ _
INCREASEDMORTALITYIN ELDERLYPATIENTSWITHDEMENTIA-RELATED PSYCHOSIS
· ELDERLY PATIENTS WITHDEMENTIA-RELATEDPSYCHOSIS TREATEDWITH
ANTIPSYCHOTICDRUGSAREATANINCREASEDRISKOFDEATH.QUETIAPINE TABLETS IS
NOT APPROVED
FORELDERLYPATIENTS WITH DEMENTIA-RELATEDPSYCHOSIS (5.1)
SUICIDALTHOUGHTSANDBEHAVIORS
· INCREASEDRISKOFSUICIDALTHOUGHTSANDBEHAVIORIN CHILDREN,
ADOLESCENTSANDYOUNGADULTSTAKINGANTIDEPRESSANTS (5.2)
· MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS (5.2)
RECENT MAJOR CHANGES
WarningsandPrecautions,CerebrovascularAdverseReactions,Including
Stroke,inElderlyPatientswithDementia-Related Psychosis(5.3) 4/2013
INDICATIONS AND USAGE
Quetiapineis an atypical antipsychotic indicated forthetreatmentof:
· Schizophrenia (1.1)
· BipolarIdisordermanicepisodes (1.2)
· Bipolar disorder, depressive episodes (1.2)
DOSAGE AND ADMINISTRATION
Quetiapine tablets, USP can betakenwithor 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
_GeriatricUse: _Consider alower starting d