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1.1 Schizophrenia
Quetiapine fumarate tablet is 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 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 fumarate 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 fumarate 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 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)].
1.3Special 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.
Quetiapine is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2•C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:
Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water.
Quetiapine fumarate tablet is supplied for oral administration as 25 mg (round, pink), 50 mg (round, white to off white), 100 mg (round, yellow), 200 mg (round, white to off white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets.
Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide.
The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow.
Each 25 mg tablet contains quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains quetiapine fumarate equivalent to 400 mg quetiapine.