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quetiapine 50 MG Oral Tablet

1 INDICATIONS AND USAGE Quetiapine fumarate tablet is an atypical antipsychotic indicated for the treatment of: • Schizophrenia ( 1.1 ) • Bipolar I disorder manic episodes ( 1.2 ) • Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine fumarate tablet is indicated for the treatment of Schizophrenia. The efficacy of quetiapine fumarate tablets 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 fumarate tablets for the maintenance treatment of Schizophrenia has not been systematically evaluated in controlled clinical trials. [see Clinical Studies (14.1)] 1.2 Bipolar Disorder Quetiapine fumarate tablet is 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 fumarate tablet 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 Clinical Studies (14.2)] . Quetiapine fumarate tablet is indicated for the maintenance treatment of Bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine fumarate tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials. [ see Clinical Studies (14.2)] . 1.3Special 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.

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4 years ago ROUND WHITE 50 quetiapine 50 MG Oral Tablet

ROUND WHITE 50

4 years ago ROUND WHITE 50 quetiapine 50 MG Oral Tablet

50 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

QUETIAPINE FUMARATE tablets are available as: 50 mg Tablets (NDC 63187-219) white to off white, round, biconvex, film coated tablet, debossed '50' on one side and plain on other side, are supplied in bottles of 30, 60 and 90 tablets. (NDC 63187-219-30), 60 tablets (NDC 63187-299-60) and 90 tablets (63187-219-90). 100 mg Tablets (NDC 63187-269) yellow coloured, round, biconvex, film coated tablet, debossed ‘100’ on one side and ‘Q’ on other side, are supplied in bottles of 30, 60 and 90 tablets. (NDC 63187-269-30), 60 tablets (NDC 63187-269-60) and 90 tablets (NDC 63187-269-90). Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP].


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