QUETIAPINE FUMARATE EXTENDED RELEASE- quetiapine fumarate tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quetiapine fumarate extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate 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 fumarate 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 fumarate 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

Product summary:

Store quetiapine fumarate extended-release tablets at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

These highlights do not include all the information
needed to use QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS safely
and effectively. See full prescribing information for QUETIAPINE
FUMARATE EXTENDED-RELEASE TABLETS.
QUETIAPINE FUMARATE EXTENDED-RELEASE tablets, for oral use
Initial U.S. Approval: 1997

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QUETIAPINE
FUMARATE EXTENDED RELEASE- quetiapine fumarate tablet,
film coated, extended release  REMEDYREPACK
INC.
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MEDICATION GUIDE

Quetiapine Fumarate (kweh-TIE-ah-
peen)
Extended-Release Tablets
Read this Medication Guide before you start taking
quetiapine fumarate 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 fumarate extende

Read the complete document

Summary of Product characteristics

QUETIAPINE FUMARATE EXTENDED RELEASE- QUETIAPINE FUMARATE TABLET, FILM
COATED,
EXTENDED RELEASE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE FUMARATE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR QUETIAPINE FUMARATE
EXTENDED-RELEASE TABLETS.
QUETIAPINE FUMARATE 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 FUMARATE 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, Leukopenia, Neutropenia and Agranulocytosis
(5.10) 11/2018
Warnings and Precautions, Anticholinergic (antimuscarinic) Effects
(5.20) 11/2018
INDICATIONS AND USAGE
Quetiapine fumarate is an 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)
_Hepat