QUETIAPINE FUMARATE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Breckenridge Pharmaceutical, Inc

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
BRECKENRIDGE PHARMACEUTICAL, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE FUMARATE SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR QUETIAPINE FUMARATE
QUETIAPINE FUMARATE TABLETS
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 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, Cerebrovascular Adverse Reactions, Including
Stroke, in Elderly Patients with Dementia-
Related Psychosis (5.3) 4/2013
INDICATIONS AND USAGE
Quetiapine fumarate is an atypical antipsychotic indicated for the
treatment of: (1)
· Schizophrenia (1.1) (1)
· Bipolar I disorder manic episodes (1.2) (1)
· Bipolar disorder, depressive episodes (1.2) (1)
DOSAGE AND ADMINISTRATION
Quetiapine fumarate can be taken with or without food. (2.1) (2)
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-