24 HR quetiapine 50 MG Extended Release Oral Tablet
1 INDICATIONS & USAGE Quetiapine Fumarate Extended-release Tablets USP 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 ) 1.1 Schizophrenia Quetiapine Fumarate Extended-release Tablets USP is indicated for the treatment of schizophrenia. The efficacy of Quetiapine Fumarate Extended-release Tablets USP 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) ]. 1.2 Bipolar Disorder Quetiapine Fumarate Extended-release Tablets USP is 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 USP 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 associated with bipolar I disorder as well as one 3-week monotherapy trial in children and adolescents (10 – 17 years) with manic episodes associated with bipolar I disorder treated with quetiapine fumarate tablets [see Clinical Studies (14.2) ]. Quetiapine Fumarate Extended-release Tablets USP is indicated for the acute treatment of depressive episodes associated with bipolar disorder. The efficacy of Quetiapine Fumarate Extended-release Tablets USP was established in one 8-week trial in adults with bipolar I or II disorder and supported by two 8-week trials in adults with bipolar I or II disorder treated with quetiapine fumarate tablets [see Clinical Studies (14.2) ]. Quetiapine Fumarate Extended-release Tablets USP is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was extrapolated from two maintenance trials in adults with bipolar I disorder treated with quetiapine fumarate tablets. The effectiveness of monotherapy for the maintenance treatment of bipolar I disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2) ]. 1.3 Adjunctive Treatment of Major Depressive Disorder (MDD) Quetiapine Fumarate Extended-release Tablets USP is indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of Quetiapine Fumarate Extended-release Tablets USP as adjunctive therapy to antidepressants in MDD was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant treatment [see Clinical Studies (14.3) ]. 1.4 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
MALLINCKRODT INC
OVAL RED Q50
Q50 OVAL RED
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24 HR quetiapine 50 MG Extended Release Oral Tablet
MALLINCKRODT INC
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16 HOW SUPPLIED/STORAGE AND HANDLING 50 mg extended-release tablets, maroon, film-coated, oval-shaped, biconvex, debossed “Q50” on one side and plain on the other are supplied in bottles of 60 tablets (NDC 0406-1180-60). 150 mg extended-release tablets, white, film-coated, capsule-shaped, biconvex, debossed “Q150” on one side and plain on the other are supplied in bottles of 60 tablets (NDC 0406-1181-60). 200 mg extended-release tablets, pale yellow, film-coated, capsule-shaped, biconvex, debossed “Q200” on one side and plain on the other are supplied in bottles of 60 tablets (NDC 0406-1182-60). 300 mg extended-release tablets, pale yellow, film-coated, capsule-shaped, biconvex, debossed “Q300” on one side and plain on the other are supplied in bottles of 60 tablets (NDC 0406-1183-60). 400 mg extended-release tablets, white, film-coated, capsule-shaped, biconvex, debossed “Q400” on one side and plain on the other are supplied in bottles of 60 tablets (NDC 0406-1184-60). Store Quetiapine Fumarate Extended-Release Tablets USP at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP Controlled Room Temperature].
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