QUETIAPINE FUMARATE- quetiapine fumarate tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Lake Erie Medical DBA Quality Care Products LLC

INN (Међународно име):

QUETIAPINE FUMARATE

Састав:

QUETIAPINE 200 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

25 mg tablets are peach, round, biconvex, film-coated tablets, debossed with ‘25’ on one side and plain on the other side and are supplied as: 50 mg tablets are white, round, biconvex, film-coated tablets, debossed with ‘50’ on one side and plain on the other side and are supplied as: 100 mg tablets are yellow, round, biconvex, film-coated tablets, debossed with ‘904’ on one side and plain on the other side and are supplied as: 200 mg tablets are white, round, biconvex, film-coated tablets, debossed with ‘905’ on one side and plain on the other side and are supplied as: 55700-084-30 55700-084-90 300 mg tablets are white, capsule-shaped, biconvex, film-coated tablets, debossed with ‘906’ on one side and plain on the other side and are supplied as: 400 mg tablets are yellow, capsule-shaped, biconvex, film-coated tablets, debossed with ‘907’ on one side and plain on the other side and are supplied as: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
Quetiapine Fumarate
(kwe-TYE-a-peen FUE-ma-rate)
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 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

Карактеристике производа

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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
• 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 fumarate tablets are 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 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
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
be dtime
300 mg/day
300
mg/day
_Geriatric Use:_ Consider a lower starting dose (50 mg/day), slower
titration and