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quetiapine 25 mg

1 INDICATIONS AND USAGE Quetiapine 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 tablet is 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 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 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 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 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.

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6 years ago ROUND PINK 25 quetiapine 25 mg

ROUND PINK 25

6 years ago ROUND PINK 25 quetiapine 25 mg

25 ROUND PINK

16 HOW SUPPLIED/STORAGE AND HANDLING 25 mg Tablets (NDC 16729-145) pink coloured, round, biconvex, film coated tablet, debossed ‘25’ on one side and plain on other side, are supplied as follow: Bottles of 30 Tablets with child-resistant closure (NDC 16729-145-10) Bottles of 100 Tablets with child-resistant closure (NDC 16729-145-01) Bottles of 1000 tablets (NDC 16729-145-17) 50 mg Tablets (NDC 16729-146) white to off white, round, biconvex, film coated tablet, debossed ‘50’ on one side and plain on other side, are supplied as follow: Bottles of 30 Tablets with child-resistant closure (NDC 16729-146-10) Bottles of 100 Tablets with child-resistant closure (NDC 16729-146-01) Bottles of 1000 tablets (NDC 16729-146-17) 100 mg Tablets (NDC 16729-147) yellow coloured, round, biconvex film coated tablet, debossed ‘100’ on one side and ‘Q’ on other side, are supplied as follow: Bottles of 30 Tablets with child-resistant closure (NDC 16729-147-10) Bottles of 100 Tablets with child-resistant closure (NDC 16729-147-01) Bottles of 1000 tablets (NDC 16729-147-17) 200 mg Tablets (NDC 16729-148) white to off white, round, biconvex, film coated tablet, debossed ‘200’ on one side and plain on other side, are supplied as follow: Bottles of 30 Tablets with child-resistant closure (NDC 16729-148-10) Bottles of 100 Tablets with child-resistant closure (NDC 16729-148-01) Bottles of 1000 tablets (NDC 16729-148-17) 300 mg Tablets (NDC 16729-149) white to off white, capsule shaped, biconvex, film coated tablet, debossed ‘300’ on one side and plain on other side, are supplied as follow: Bottles of 30 Tablets with child-resistant closure (NDC 16729-149-10) Bottles of 60 Tablets with child-resistant closure (NDC 16729-149-12) Bottles of 100 Tablets with child-resistant closure (NDC 16729-149-01) Bottles of 1000 tablets (NDC 16729-149-17) 400 mg Tablets (NDC 16729-150) yellow coloured, capsule shaped, biconvex, film coated tablet, debossed ‘400’ on one side and plain on other side, are supplied as follow: Bottles of 30 Tablets with child-resistant closure (NDC 16729-150-10) Bottles of 100 Tablets with child-resistant closure (NDC 16729-150-01) Bottles of 500 tablets (NDC 16729-150-16) 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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