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:

Avera McKennan Hospital

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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) ]. Quetiapineis 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 Clinica

Product summary:

Quetiapine tablets, USP 400 mg Yellow coloured, film coated, capsule shaped, biconvex tablets, debossed with "336" on one side and plain on other side. Bottles of 100 tablets                                                                   NDC 67877-248- 01 Bottles of 1000 tablets                                                                 NDC 67877-248-10 Carton pack of 100 tablets (10 x 10's blister pack)                      NDC 67877-248-38 Carton pack of 10 tablets (1 x 10's blister pack)                          NDC 67877-248-33 NDC 69189-0580-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
AVERA MCKENNAN HOSPITAL
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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 (50