QUETIAPINE FUMARATE tablet

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 100 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
REMEDYREPACK INC.
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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: INCREASEDMORTALITYINELDERLYPATIENTS WITHDEMENTIA-
RELATEDPSYCHOSIS;ANDSUICIDAL THOUGHTSANDBEHAVIORS
_SEEFULLPRESCRIBING INFORMATIONFORCOMPLETEBOXEDWARNING._
_ _
INCREASEDMORTALITYIN ELDERLYPATIENTSWITHDEMENTIA-RELATED PSYCHOSIS
· ELDERLY PATIENTS WITHDEMENTIA-RELATEDPSYCHOSIS TREATEDWITH
ANTIPSYCHOTICDRUGSAREATANINCREASEDRISKOFDEATH.QUETIAPINE TABLETS IS
NOT APPROVED FORELDERLYPATIENTS
WITH DEMENTIA-RELATEDPSYCHOSIS (5.1)
SUIC IDALT HO UG HTSANDBE HAVIO RS
· INCREASEDRISKOFSUICIDALTHOUGHTSANDBEHAVIORIN CHILDREN,
ADOLESCENTSANDYOUNGADULTSTAKINGANTIDEPRESSANTS (5.2)
· MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS (5.2)
RECENT MAJOR CHANGES
WarningsandPrecautions,CerebrovascularAdverseReactions,Including
Stroke,inElderlyPatientswithDementia-Related
Psychosis(5.3) 4/2013
INDICATIONS AND USAGE
Quetiapineis an atypical antipsychotic indicated forthetreatmentof:
· Schizophrenia (1.1)
· BipolarIdisordermanicepisodes (1.2)
· Bipolar disorder, depressive episodes (1.2)
DOSAGE AND ADMINISTRATION
Quetiapine tablets, USP can betakenwithor 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),
Monotherapy (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
_GeriatricUse: _Consider alower starting dose (