quetiapine 400 mg
1 INDICATIONS AND USAGE Quetiapine tablets are 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 tablets are indicated for the treatment of Schizophrenia. The efficacy of quetiapine 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 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 tablets are 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 tablets are 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 tablets are 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 tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2) ] . 1.3 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.
Aurobindo Pharma Limited
OVAL WHITE F 85
F 85 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Quetiapine Tablets, USP 25 mg are peach, round, biconvex, film-coated tablets debossed with ‘E 52’ on one side and plain on the other side. Bottles of 100 NDC 65862-489-01 Bottles of 1,000 NDC 65862-489-99 10 x 10 Unit-dose Tablets NDC 65862-489-10 Quetiapine Tablets, USP 50 mg are white, round, biconvex, film-coated tablets imprinted with ‘F 84’ on one side and plain on the other side. Bottles of 100 NDC 65862-490-01 Bottles of 1,000 NDC 65862-490-99 10 x 10 Unit-dose Tablets NDC 65862-490-10 Quetiapine Tablets, USP 100 mg are yellow, round, biconvex, film-coated tablets imprinted with ‘E 53’ on one side and plain on the other side. Bottles of 100 NDC 65862-491-01 Bottles of 1,000 NDC 65862-491-99 10 x 10 Unit-dose Tablets NDC 65862-491-10 Quetiapine Tablets, USP 150 mg are light yellow, round, biconvex, film-coated tablets imprinted with ‘E 54’ on one side and plain on the other side. Bottles of 100 NDC 65862-492-01 Bottles of 1,000 NDC 65862-492-99 10 x 10 Unit-dose Tablets NDC 65862-492-10 Quetiapine T ablets, USP 200 mg are white, round, biconvex, film-coated tablets imprinted with ‘E 55’ on one side and plain on the other side. Bottles of 100 NDC 65862-493-01 Bottles of 1,000 NDC 65862-493-99 10 x 10 Unit-dose Tablets NDC 65862-493-10 Quetiapine Tablets, USP 300 mg are white, capsule shaped, biconvex, film-coated tablets imprinted with ‘E 56’ on one side and plain on the other side. Bottles of 60 NDC 65862-494-60 Bottles of 100 NDC 65862-494-01 Bottles of 1,000 NDC 65862-494-99 10 x 10 Unit-dose Tablets NDC 65862-494-10 Quetiapine Tablets, USP 400 mg are yellow, capsule shaped, biconvex, film-coated tablets imprinted with ‘F 85’ on one side and plain on the other side. Bottles of 100 NDC 65862-495-01 Bottles of 500 NDC 65862-495-05 10 x 10 Unit-dose Tablets NDC 65862-495-10 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [see USP Controlled Room Temperature].
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