24 hr quetiapine 150 mg extended release oral tablet
1 INDICATIONS AND USAGE Quetiapine extended-release tablet 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 extended-release tablets are indicated for the treatment of Schizophrenia. The efficacy of quetiapine extended-release tablets 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 tablets [see Clinical Studies ( 14.1 )]. 1.2 Bipolar Disorder Quetiapine extended-release tablets are 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 extended-release tablets 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 tablets [see Clinical Studies ( 14.2 )]. Quetiapine extended-release tablets are indicated for the acute treatment of depressive episodes associated with bipolar disorder. The efficacy of quetiapine extended-release tablets 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 tablets [see Clinical Studies ( 14.2 )]. Quetiapine extended-release tablets are 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 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 extended-release tablets are indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of quetiapine extended-release tablets 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.
ingenus pharmaceuticals, llc
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24 hr quetiapine 150 mg extended release oral tablet
ingenus pharmaceuticals, llc
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16 HOW SUPPLIED/STORAGE AND HANDLING 50 mg Tablets (NDC 50742-635) pink, film-coated, capsule-shaped, biconvex, debossed tablet with "NT 50"on one side and plain on the other are supplied in bottles of 30 (NDC 50742-635-30), 60 (NDC 50742-635-60), 90 (NDC 50742-635-90) and 1000 (NDC 50742-635-10) tablets. 150 mg Tablets (NDC 50742-636) white, film-coated, capsule-shaped, biconvex, debossed tablet with "NT 150" on one side and plain on the other are supplied in bottles of 30 (NDC 50742-636-30), 60 (NDC 50742-636-60), 90 (NDC 50742-636-90) and 1000 (NDC 50742-636-10) tablets. 200 mg Tablets (NDC 50742-637) yellow, film-coated, capsule-shaped, biconvex, debossed tablet with "NT 200" on one side and plain on the other are supplied in bottles of 30 (NDC 50742-637-30), 60 (NDC 50742-637-60), 90 (NDC 50742-637-90) and 1000 (NDC 50742-637-10) tablets. 300 mg Tablets (NDC 50742-638) light yellow, film-coated, capsule-shaped, biconvex, debossed tablet with "NT 300" on one side and plain on the other are supplied in bottles of 30 (NDC 50742-638-30), 60 (NDC 50742-638-60), 90 (NDC 50742-638-90) and 1000 (NDC 50742-638-10) tablets. 400 mg Tablets (NDC 50742-639) white, film-coated, capsule-shaped, biconvex, debossed tablet with "NT 400" on one side and plain on the other are supplied in bottles of 30 (NDC 50742-639-30), 60 (NDC 50742-639-60), 90 (NDC 50742-639-90) and 1000 (NDC 50742-639-10) tablets. Store quetiapine extended-release tablets, USP at 25 ºC (77 ºF); excursions permitted to 15-30 ºC (59-86 ºF) [See USP Controlled Room Temperature].
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