Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)
Avera McKennan Hospital
QUETIAPINE FUMARATE
QUETIAPINE 400 mg
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET AVERA MCKENNAN HOSPITAL ---------- 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 Прочетете целия документ