quetiapine fumarate quetiapine 100 MG Oral Tablet
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 fumarate tablets in Schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 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 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 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 ) ]. 1.3 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.
Apotex Corp.
ROUND YELLOW APO QUE 100
APO QUE 100 ROUND YELLOW
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quetiapine 400 MG Oral Tablet
Apotex Corp.
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16 HOW SUPPLIED/STORAGE AND HANDLING Quetiapine tablets, USP Quetiapine tablets, USP 25 mg are peach, round, biconvex, film coated tablets. Engraved with 'APO' on one side and "QUE’ over ‘25’ on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-3130-3) Bottles of 100 (NDC 60505-3130-1) Bottles of 500 (NDC 60505-3130-5) Bottles of 1,000 (NDC 60505-3130-8) Blisters of 30 (NDC 60505-3130-0) Blisters of 100 (NDC 60505-3131-0) Quetiapine tablets, USP 50 mg are white, round, biconvex, film coated tablets. Engraved with 'APO' on one side and ‘QUE’ over ‘50’ on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-3132-3) Bottles of 100 (NDC 60505-3132-1) Bottles of 1,000 (NDC 60505-3132-8) Blisters of 100 (NDC 60505-3132-0) Quetiapine tablets, USP 100 mg are yellow, round, biconvex film coated tablets. Engraved with 'APO' on one side and ‘QUE’ over ‘100’ on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-3133-3) Bottles of 100 (NDC 60505-3133-1) Bottles of 500 (NDC 60505-3133-5) Bottles of 1,000 (NDC 60505-3133-8) Blisters of 30 (NDC 60505-3133-0) Blisters of 100 (NDC 60505-3134-0) Quetiapine tablets, USP 200 mg are white, round, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE’ over ‘200’ on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-3135-3) Bottles of 100 (NDC 60505-3135-1) Bottles of 500 (NDC 60505-3135-5) Bottles of 1,000 (NDC 60505-3135-8) Blisters of 30 (NDC 60505-3135-0) Blisters of 100 (NDC 60505-3136-0) Quetiapine tablets, USP 300 mg are white, capsule-shaped, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE300’ on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-3137-3) Bottles of 60 (NDC 60505-3137-6) Bottles of 100 (NDC 60505-3137-1) Bottles of 500 (NDC 60505-3137-5) Bottles of 1,000 (NDC 60505-3137-8) Blisters of 30 (NDC 60505-3137-0) Blisters of 100 (NDC 60505-3138-0) Quetiapine tablets, USP 400 mg are yellow, capsule-shaped, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE 400’ on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-3139-3) Bottles of 100 (NDC 60505-3139-1) Bottles of 1,000 (NDC 60505-3139-8) Blisters of 100 (NDC 60505-3139-0) Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15°C to 30ºC (59°F to 86ºF) [See USP Controlled Room Temperature].
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