SEROQUEL- quetiapine fumarate tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Rebel Distributors Corp

INN (इंटरनेशनल नाम):

QUETIAPINE FUMARATE

रचना:

QUETIAPINE FUMARATE 25 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6–week trial in adolescents (13–17 years). The effectiveness of SEROQUEL for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)] SEROQUEL is 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 (10-17 years) [see Clinical Studies (14.2)]. SEROQUEL 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)]. SERO

उत्पाद समीक्षा:

25 mg Tablets (NDC 21695-117-25) peach, round, biconvex, film coated tablets, identified with 'SEROQUEL' and ‘25’ on one side and plain on the other side, are supplied in bottles of 100 tablets and 1000 tablets, and hospital unit dose packages of 100 tablets. 50 mg Tablets (NDC21695-118-50) white, round, biconvex, film coated tablets, identified with 'SEROQUEL' and ‘50’ on one side and plain on the other side, are supplied in bottles of 100 tablets and 1000 tablets, and hospital unit dose packages of 100 tablets. 100 mg Tablets (NDC 21695-119-01) yellow, round, biconvex film coated tablets, identified with 'SEROQUEL' and ‘100’ on one side and plain on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets. 200 mg Tablets (NDC 21695-120-02) white, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘200’ on one side and plain on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets. Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP].

प्राधिकरण का दर्जा:

New Drug Application

सूचना पत्रक

SEROQUEL- QUETIAPINE FUMARATE TABLET, FILM COATED
Rebel Distributors Corp
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SPL MEDGUIDE SECTION
Medication Guide
SEROQUEL (SER-oh-kwell)
(quetiapine fumarate)
Tablets
Read this Medication Guide before you start taking SEROQUEL and each
time you get a refill. There
may be new information. This Medication Guide does not take the place
of talking to your healthcare
provider about your medical condition or treatment.
What is the most important information I should know about SEROQUEL?
Serious side effects may happen when you take SEROQUEL, including
•
Risk of death in the elderly with dementia: Medicines like SEROQUEL
can raise the risk of death
in elderly people who have lost touch with reality due to confusion
and memory loss (dementia).
SEROQUEL is not approved for treating psychosis in the elderly with
dementia.
•
Risk of suicidal thoughts or actions: Antidepressant medicines,
depression and other serious
mental illnesses, and suicidal thoughts or actions:
•
.
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children,
teenagers, and young adults within the first few months of treatment.
2.
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.
3.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family
member?
4.
.
•
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 new or sudden
changes in mood,
behavior, thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the
healthcare provider between

उत्पाद विशेषताएं

SEROQUEL- QUETIAPINE FUMARATE TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEROQUEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SEROQUEL.
SEROQUEL (QUETIAPINE FUMARATE) TABLETS
INITIAL U.S. APPROVAL: 1997
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED
WARNING._
ANTIPSYCHOTIC DRUGS ARE ASSOCIATED WITH AN INCREASED RISK OF DEATH
(5.1)
QUETIAPINE IS NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS (5.1)
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS _SEE FULL PRESCRIBING
INFORMATION FOR COMPLETE_
_BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER AND OTHER PSYCHIATRIC
DISORDERS (5.2)
RECENT MAJOR CHANGES
BOXED WARNING: Suicidality and Antidepressant Drugs, 12/2009
Indications and Usage, Schizophrenia (1.1), 12/2009
Indications and Usage, Bipolar Disorder (1.2), 12/2009
Indications and Usage, Special Considerations in Treating Pediatric
Patients with Schizophrenia and Bipolar I Disorder
(1.3), 12/2009
Dosage and Administration, Schizophrenia, Adolescents (2.1), 12/2009
Dosage and Administration, Bipolar Mania, Children and Adolescents
(2.2), 12/2009
Warnings and Precautions, Hyperglycemia (5.4), 12/2009
Warnings and Precautions, Hyperlipidemia (5.5), 12/2009
Warnings and Precautions, Weight Gain (5.6), 12/2009
Warnings and Precautions, Increases in Blood Pressure in Children and
Adolescents (5.9), 12/2009
Warnings and Precautions, Use in Patients with Concomitant Illness
(5.21), 01/2010
Warnings and Precautions, Withdrawal (5.22), 05/2010
INDICATIONS AND USAGE
SEROQUEL is an atypical antipsychotic agent indicated for the: (1)
Treatment of schizophrenia (1.1) (1)
Adults: Efficacy was established in three 6–week clinical trials in
patients with schizophrenia (14.1)
Adolescents (a