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Seroquel 50 MG Oral Tablet

1 INDICATIONS AND USAGE SEROQUEL 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 SEROQUEL is indicated for the treatment of Schizophrenia. The efficacy of SEROQUEL in Schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). The effectiveness of SEROQUEL for the maintenance treatment of Schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder SEROQUEL 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 (10-17 years) [see Clinical Studies (14.2) ]. SEROQUEL 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) ]. SEROQUEL 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 SEROQUEL 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.

AstraZeneca Pharmaceuticals LP


8 years ago ROUND WHITE Seroquel 50 Seroquel 50 MG Oral Tablet

ROUND WHITE Seroquel 50

16 HOW SUPPLIED/STORAGE AND HANDLING 25 mg Tablets (NDC 0310-0275-10) peach, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘25’ on one side and plain on the other side, are supplied in bottles of 100 tablets. 50 mg Tablets (NDC 0310-0278-10) white, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘50’ on one side and plain on the other side, are supplied in bottles of 100 tablets. 100 mg Tablets (NDC 0310-0271-10) yellow, round, biconvex film coated tablets, identified with ‘SEROQUEL’ and ‘100’ on one side and plain on the other side, are supplied in bottles of 100 tablets. 200 mg Tablets (NDC 0310-0272-10) white, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘200’ on one side and plain on the other side, are supplied in bottles of 100 tablets. 300 mg Tablets (NDC 0310-0274-60) white, capsule-shaped, biconvex, film coated tablets, intagliated with ‘SEROQUEL’ on one side and ‘300’ on the other side, are supplied in bottles of 60 tablets. 400 mg Tablets (NDC 0310-0279-10) yellow, capsule-shaped, biconvex, film coated tablets, intagliated with ‘SEROQUEL’ on one side and ‘400’ on the other side, are supplied in bottles of 100 tablets. Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP].

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