quetiapine fumarate 100 mg
1 INDICATIONS AND USAGE Quetiapine 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 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.
camber pharmaceuticals, inc.
ROUND YELLOW I 55
I 55 ROUND YELLOW
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quetiapine fumarate 100 mg
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quetiapine fumarate 25 mg
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16 HOW SUPPLIED/STORAGE AND HANDLING Quetiapine tablets, USP 25 mg are peach colored, round shaped, biconvex, film-coated tablets debossed with β44β on one side and βIβ on the other side. They are supplied as follows: Bottle of 100 tablets NDC 31722-764-01 Bottle of 500 tablets NDC 31722-764-05 Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-764-31 Blister Pack of 100 (10x10) unit dose tablets (Alu-Alu) NDC 31722-764-32 Blister Card of 10 unit dose tablets (PVC-PVdC) NDC 31722-764-33 Blister Pack of 150 (15x10) unit dose tablets (PVC-PVdC) NDC 31722-764-34 Quetiapine tablets, USP 50 mg are white colored, round shaped, biconvex, film-coated tablets debossed with β47β on one side and βIβ on the other side. They are supplied as follows: Bottle of 100 tablets NDC 31722-765-01 Bottle of 500 tablets NDC 31722-765-05 Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-765-31 Blister Pack of 100 (10x10) unit dose tablets (Alu-Alu) NDC 31722-765-32 Blister Card of 10 unit dose tablets (PVC-PVdC) NDC 31722-765-33 Blister Pack of 100 (10x10) unit dose tablets (PVC-PVdC) NDC 31722-764-34 Quetiapine tablets, USP 100 mg are yellow colored, round shaped, biconvex, film-coated tablets debossed with β55β on one side and βIβ on the other side. They are supplied as follows: Bottle of 100 tablets NDC 31722-766-01 Bottle of 500 tablets NDC 31722-766-05 Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-766-31 Blister Pack of 100 (10x10) unit dose tablets (Alu-Alu) NDC 31722-766-32 Blister Card of 10 unit dose tablets (PVC-PVdC) NDC 31722-766-33 Blister Pack of 100 (10x10) unit dose tablets (PVC-PVdC) NDC 31722-766-34 Quetiapine tablets, USP 200 mg are white colored, round shaped, biconvex, film-coated tablets debossed with β56β on one side and βIβ on the other side. They are supplied as follows: Bottle of 100 tablets NDC 31722-767-01 Bottle of 500 tablets NDC 31722-767-05 Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-767-31 Blister Pack of 100 (10x10) unit dose tablets (Alu-Alu) NDC 31722-767-32 Blister Card of 10 unit dose tablets (PVC-PVdC) NDC 31722-767-33 Blister Pack of 100 (10x10) unit dose tablets (PVC-PVdC) NDC 31722-767-34 Quetiapine tablets, USP 300 mg are white colored, capsule shaped, biconvex, film-coated tablets debossed with β45β on one side and βIβ on the other side. They are supplied as follows: Bottle of 60 tablets NDC 31722-768-60 Bottle of 500 tablets NDC 31722-768-05 Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-768-31 Blister Pack of 100 (10x10) unit dose tablets (Alu-Alu) NDC 31722-768-32 Blister Card of 10 unit dose tablets (PVC-PVdC) NDC 31722-768-33 Blister Pack of 100 (10x10) unit dose tablets (PVC-PVdC) NDC 31722-768-34 Quetiapine tablets, USP 400 mg are yellow colored, capsule shaped, biconvex, film-coated tablets debossed with β57β on one side and βIβ on the other side. They are supplied as follows Bottle of 100 tablets NDC 31722-769-01 Bottle of 500 tablets NDC 31722-769-05 Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-769-31 Blister Pack of 100 (10x10) unit dose tablets (Alu-Alu) NDC 31722-769-32 Blister Card of 10 unit dose tablets (PVC-PVdC) NDC 31722-769-33 Blister Pack of 100 (10x10) unit dose tablets (PVC-PVdC) NDC 31722-769-34 Store at 20ΒΊ to 25ΒΊC (68ΒΊ to 77ΒΊF) [see USP Controlled Room Temperature].
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