quetiapine 25 MG Oral Tablet
1 INDICATIONS AND USAGE Quetiapine Fumarate 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 Fumarate 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 to 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 Fumarate 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 Fumarate 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 Fumarate 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.
aphena pharma solutions - tennessee, llc
ROUND WHITE 54 137
54 137 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Quetiapine Fumarate Tablets are supplied as white tablets. The 25 mg tablets are round and debossed with product identification "54 137" on one side and plain on the other side. The 50 mg tablets are oval and debossed with product identification "54" on one side and "377" on the other side. The 100 mg tablets are round and debossed with product identification "54 373" on one side and plain on the other side. The 200 mg tablets are round and debossed with product identification "54 527" on one side and plain on the other side. The 300 mg tablets are oval and debossed with product identification "54 531" on one side and plain on the other side. The 400 mg tablets are oval and debossed with product identification "54 735" on one side and plain on the other side. 0054-0220-25 25 mg, white tablet, bottle of 100 0054-0220-31 25 mg, white tablet, bottle of 1000 0054-0220-20 25 mg, white tablet, 10x10 unit dose 0054-0229-25 50 mg, white tablet, bottle of 100 0054-0229-31 50 mg, white tablet, bottle of 1000 0054-0229-20 50 mg, white tablet, 10x10 unit dose 0054-0221-25 100 mg, white tablet, bottle of 100 0054-0221-31 100 mg, white tablet, bottle of 1000 0054-0221-20 100 mg, white tablet, 10x10 unit dose 0054-0222-25 200 mg, white tablet, bottle of 100 0054-0222-29 200 mg, white tablet, bottle of 500 0054-0222-20 200 mg, white tablet, 10x10 unit dose 0054-0223-21 300 mg, white tablet, bottle of 60 0054-0223-29 300 mg, white tablet, bottle of 500 0054-0223-20 300 mg, white tablet, 10x10 unit dose 0054-0230-25 400 mg, white tablet, bottle of 100 0054-0230-20 400 mg, white tablet, 10x10 unit dose Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP].
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