QUETIAPINE FUMARATE- quetiapine fumarate tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Lake Erie Medical DBA Quality Care Products LLC

INN (इंटरनेशनल नाम):

QUETIAPINE FUMARATE

रचना:

QUETIAPINE 25 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Quetiapine tablets USP are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets USP 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 tablets USP for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES (14.1 )]. Quetiapine tablets USP 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 tablets USP are 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 p

उत्पाद समीक्षा:

Quetiapine tablets USP , 25 mg (as quetiapine) are pink colored, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y15" on the other side, which are supplied as follows: 55700-144-30 Quetiapine tablets USP , 50 mg (as quetiapine) are white, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y16" on the other side, which are supplied as follows: Quetiapine tablets USP, 100 mg (as quetiapine) are yellow colored, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y17" on the other side, which are supplied as follows: Quetiapine tablets USP, 200 mg (as quetiapine) are white, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y18" on the other side, which are supplied as follows: Quetiapine tablets USP, 300 mg (as quetiapine) are white, capsule shape, biconvex, film-coated tablets, debossed "LU" on one side and "Y19" on the other side, which are supplied as follows: Quetiapine tablets USP, 400 mg (as quetiapine) are yellow colored, capsule shape, biconvex, film-coated tablets, debossed "LU" on one side and "Y20" on the other side, which are supplied as follows: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
Quetiapine (kwe-TYE-a-peen) Tablets USP
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
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.
•
Call the healthcare provider right away to report ne

उत्पाद विशेषताएं

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUETIAPINE TABLETS
USP.
QUETIAPINE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING:INCREASEDMORTALITYINELDERLYPATIENTSWITHDEMENTIA-
RELATEDPSYCHOSIS;ANDSUICIDALTHOUGHTSANDBEHAVIORS
_SEEFULLPRESCRIBINGINFORMATIONFORCOMPLETEBOXEDWARNING._
INC RE ASE DMO RTALITYINELDE RLYPATIE NTSWITHDE M E NTIA-RE LATE DPSYC
HO SIS
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)
SUIC IDALT HO UG HTSANDBE HAVIO RS
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 tablet USP 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 fumarate tablets USP 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
GERIATRICUSE: Consider a lower starting dose (50 mg/day), slower
titration and careful monitoring during the initi