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quetiapine 100 MG Oral Tablet

1 INDICATIONS AND USAGE Quetiapine 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 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 )]. 1.2 Bipolar Disorder Quetiapine 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 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 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 as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies ( 14.2 )]. 1.3 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.

West-Ward Pharmaceuticals Corp


3 years ago ROUND WHITE 54 373 quetiapine 100 MG Oral Tablet

ROUND WHITE 54 373

3 years ago ROUND WHITE 54 373 quetiapine 100 MG Oral Tablet

54 373 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING Quetiapine Tablets USP 25 mg tablets are supplied as a round, white to off-white, standard biconvex tablet debossed with product identification “54” over “137” on one side and plain on the other side. NDC 0054-0220-25: Bottle of 100 Tablets NDC 0054-0220-31: Bottle of 1,000 Tablets NDC 0054-0220-20: 2 x 5 x 10 Unit-Dose Tablets 50 mg tablets are supplied as a white to off-white, oval, standard biconvex tablet debossed with product identification “54” on one side and “377” on the other side. NDC 0054-0229-25: Bottle of 100 Tablets NDC 0054-0229-31: Bottle of 1,000 Tablets NDC 0054-0229-20: 2 x 5 x 10 Unit-Dose Tablets 100 mg tablets are supplied as a round, white to off-white, standard biconvex tablet debossed with product identification “54” over “373” on one side and plain on the other side. NDC 0054-0221-25: Bottle of 100 Tablets NDC 0054-0221-20: 2 x 5 x 10 Unit-Dose Tablets 200 mg tablets are supplied as a round, white to off-white, standard biconvex tablet debossed with product identification “54” over “527” on one side and plain on the other side. NDC 0054-0222-25: Bottle of 100 Tablets 300 mg tablets are supplied as a white to off-white, oval, standard biconvex tablet debossed with product identification “54 531” on one side and plain on the other side. NDC 0054-0223-21: Bottle of 60 Tablets NDC 0054-0223-20: 2 x 5 x 10 Unit-Dose Tablets 400 mg tablets are supplied as a white to off-white, oval, standard biconvex tablet debossed with product identification “54 735” on one side and plain on the other side. NDC 0054-0230-25: Bottle of 100 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]


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