QUETIAPINE FUMARATE tablet, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

REMEDYREPACK INC.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

​ Quetiapine Extended-Release Tablets are indicated for the treatment of schizophrenia. The efficacy of Quetiapine Extended-Release Tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with Quetiapine Fumarate Tablets [see Clinical Studies (14.1) ]. Quetiapine Extended-Release Tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of Quetiapine Extended-Release Tablets in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated wi

產品總結:

400 mg Tablets: White, film coated, capsule-shaped tablets engraved with “P13” on one side. NDC: 70518-2702-00 NDC: 70518-2702-01 PACKAGING: 30 in 1 BOX PACKAGING: 1 in 1 POUCH Store Quetiapine Extended-Release Tablets at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

授权状态:

Abbreviated New Drug Application

资料单张

QUETIAPINE FUMARATE- quetiapine fumarate tablet, extended release
REMEDYREPACK INC.
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MEDICATION GUIDE
Quetiapine Extended-Release Tablets
(kwe-TYE-a-peen)
The 200 mg strength tablet of this drug product contains FD&C yellow
No.5 (tartrazine) which may cause
allergic-type reactions (including bronchial asthma) in certain
susceptible persons. Although the overall
incidence of FD&C Yellow No.5 (tartrazine) sensitivity in the general
population is low, it is frequently seen
in patients who also have aspirin hypersensitivity.
Read this Medication Guide before you start taking Quetiapine
Extended-Release Tablets 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 Quetiapine
Extended-Release Tablets?
Quetiapine Extended-Release Tablets may cause serious side effects,
including:
1.
risk of death in the elderly with dementia: Medicines like Quetiapine
Extended-Release Tablets can
increase the risk of death in elderly people who have memory loss
(dementia). Quetiapine Extended-
Release 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 medicines 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

产品特点

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR QUETIAPINE
EXTENDED-RELEASE TABLETS.
QUETIAPINE EXTENDED-RELEASE 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 EXTENDED-RELEASE TABLETS
ARE 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 ( 5.20) 09/2020
INDICATIONS AND USAGE
Quetiapine Extended-Release Tablets are atypical antipsychotic
indicated for the treatment of:
Schizophrenia (1.1)
Bipolar I disorder, manic or mixed episodes (1.2)
Bipolar disorder, depressive episodes (1.2)
Major depressive disorder, adjunctive therapy with antidepressants
(1.3)
DOSAGE AND ADMINISTRATION
Swallow tablets whole and do not split, chew or crush (2.1)
Take without food or with a light meal (approx. 300 calories) (2.1)
Administer once daily, preferably in the evening (2.1)
_Geriatric Use:_ Consider a lower starting dose (50 mg/day), slower
titration, and careful monitoring
during the initial dosing period in the elderly. (2.3, 8.5)
_Hepatic Impairment:_ Lower starting dose (50 mg/day) and slower
titration may be needed (2.4, 8.7,
12.3)
Indication
Initial
Dose
Recommended
Dose
Maximum
Dose
Schizophrenia-
Adults (2