quetiapine 25 mg
1 INDICATIONS AND USAGE Quetiapine tablet USP 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 tablets USP are indicated for the treatment of Schizophrenia. The efficacy of quetiapine tablets USP 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 USP 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 USP 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 USP 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 USP 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 USP 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.
Lupin Pharmaceuticals, Inc.
ROUND PINK Y15 LU
Y15 LU ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING Quetiapine tablets USP , 25 mg (as quetiapine) are pink colored, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y15" on the other side, which are supplied as follows: NDC 68180-445-01 Bottle of 100s NDC 68180-445-03 Bottle of 1000s NDC 68180-445-13 Unit Dose Blisters of 10 x 10s Quetiapine tablets USP , 50 mg (as quetiapine) are white, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y16" on the other side, which are supplied as follows: NDC 68180-446-01 Bottle of 100s NDC 68180-446-03 Bottle of 1000s NDC 68180-446-13 Unit Dose Blisters of 10 x 10s Quetiapine tablets USP, 100 mg (as quetiapine) are yellow colored, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y17" on the other side, which are supplied as follows: NDC 68180-447-01 Bottle of 100s NDC 68180-447-03 Bottle of 1000s NDC 68180-447-13 Unit Dose Blisters of 10 x 10s Quetiapine tablets USP, 200 mg (as quetiapine) are white, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y18" on the other side, which are supplied as follows: NDC 68180-448-01 Bottle of 100s NDC 68180-448-02 Bottle of 500s NDC 68180-448-03 Bottle of 1000s NDC 68180-448-13 Unit Dose Blisters of 10 x 10s Quetiapine tablets USP, 300 mg (as quetiapine) are white, capsule shape, biconvex, film-coated tablets, debossed "LU" on one side and "Y19" on the other side, which are supplied as follows: NDC 68180-449-07 Bottle of 60s NDC 68180-449-01 Bottle of 100s NDC 68180-449-02 Bottle of 500s NDC 68180-449-03 Bottle of 1000s NDC 68180-449-13 Unit Dose Blisters of 10 x 10s Quetiapine tablets USP, 400 mg (as quetiapine) are yellow colored, capsule shape, biconvex, film-coated tablets, debossed "LU" on one side and "Y20" on the other side, which are supplied as follows: NDC 68180-450-01 Bottle of 100s NDC 68180-450-02 Bottle of 500s NDC 68180-450-03 Bottle of 1000s NDC 68180-450-13 Unit Dose Blisters of 10 x 10s Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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