QUETIAPINE FUMARATE- quetiapine fumarate tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Preferred Pharmaceuticals, Inc.

INN (International Name):

QUETIAPINE FUMARATE

구성:

QUETIAPINE 300 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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) ]. Quetiapine 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 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 adult patients with bipolar I and bipolar II disorder [see Clinical Stud

제품 요약:

Quetiapine tablets, USP 300 mg White coloured, film coated, capsule shaped, biconvex tablets, debossed with "259" on one side and plain on other side. Bottle of 30 - 68788-9490-3 Bottle of 60 - 68788-9490-6 Bottle of 90 - 68788-9490-9 Bottle of 100 - 68788-9490-1 Bottle of 120 - 68788-9490-8 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
Preferred Pharmaceuticals, Inc.
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SPL MEDGUIDE SECTION
Medication Guide
Quetiapine Tablets
(kwe-TYE-a-peen)
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?
Quetiapine 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 is 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 new or sudden
changes in mood, b

제품 특성 요약

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
PREFERRED 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: 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 TABLETS 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)
RECENT MAJOR CHANGES
Warnings and Precautions, Falls (5.8) 02/2017
INDICATIONS AND USAGE
Quetiapine 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 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),
Monothe rapy(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
· _Geriatric Use:_ Consider a lower starting dose (50 mg/day), s