quetiapine as quetiapine fumarate 25 MG Oral Tablet
1 INDICATIONS AND USAGE Quetiapine 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 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.
sun pharmaceutical industries, inc.
ROUND BROWN 25
25 ROUND BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING 25 mg tablets are peach, round, biconvex, film-coated tablets, debossed with '25' on one side and plain on the other side and are supplied as: Bottles of 30 with child-resistant cap...........................NDC 47335-902-83 Bottles of 100 with child-resistant cap.........................NDC 47335-902-88 Bottles of 1000.............................................................NDC 47335-902-18 Unit-dose blister pack of 100 (10 × 10) tablets............NDC 47335-902-61 50 mg tablets are white, round, biconvex, film-coated tablets, debossed with '50' on one side and plain on the other side and are supplied as: Bottles of 30 with child-resistant cap...........................NDC 47335-903-83 Bottles of 100 with child-resistant cap.........................NDC 47335-903-88 Bottles of 1000............................................................NDC 47335-903-18 Unit-dose blister pack of 100 (10 × 10) tablets...........NDC 47335-903-61 100 mg tablets are yellow, round, biconvex, film-coated tablets, debossed with '904' on one side and plain on the other side and are supplied as: Bottles of 30 with child-resistant cap...........................NDC 47335-904-83 Bottles of 100 with child-resistant cap.........................NDC 47335-904-88 Bottles of 1000............................................................NDC 47335-904-18 Unit-dose blister pack of 100 (10 × 10) tablets...........NDC 47335-904-61 200 mg tablets are white, round, biconvex, film-coated tablets, debossed with '905' on one side and plain on the other side and are supplied as: Bottles of 30 with child-resistant cap...........................NDC 47335-905-83 Bottles of 100 with child-resistant cap ........................NDC 47335-905-88 Bottles of 1000............................................................NDC 47335-905-18 Unit-dose blister pack of 100 (10 × 10) tablets...........NDC 47335-905-61 300 mg tablets are white, capsule-shaped, biconvex, film-coated tablets, debossed with '906' on one side and plain on the other side and are supplied as: Bottles of 30 with child-resistant cap...........................NDC 47335-906-83 Bottles of 60 with child-resistant cap...........................NDC 47335-906-86 Bottles of 100 with child-resistant cap.........................NDC 47335-906-88 Bottles of 1000............................................................NDC 47335-906-18 Unit-dose blister pack of 100 (10 × 10) tablets...........NDC 47335-906-61 400 mg tablets are yellow, capsule-shaped, biconvex, film-coated tablets, debossed with '907' on one side and plain on the other side and are supplied as: Bottles of 30 with child-resistant cap...........................NDC 47335-907-83 Bottles of 100 with child-resistant cap.........................NDC 47335-907-88 Bottles of 1000............................................................NDC 47335-907-18 Unit-dose blister pack of 100 (10 × 10) tablets...........NDC 47335-907-61 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
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