quetiapine 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 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.
Dr.Reddy's Laboratories Limited
ROUND WHITE R I
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16 HOW SUPPLIED/STORAGE AND HANDLING
QUETIAPINE FUMARATE tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-249-30 Bottles of 60 NDC 55111-249-60 Bottles of 100 NDC 55111-249-01 Bottles of 500 NDC 55111-249-05 Unit dose package of 100 (10 x 10) NDC 55111-249-78
QUETIAPINE FUMARATE tablets 50 mg are white colored, round, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘2’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-169-30 Bottles of 60 NDC 55111-169-60 Bottles of 100 NDC 55111-169-01 Bottles of 500 NDC 55111-169-05 Unit dose package of 100 (10 x 10) NDC 55111-169-78
QUETIAPINE FUMARATE tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-186-30 Bottles of 60 NDC 55111-186-60 Bottles of 100 NDC 55111-186-01 Bottles of 500 NDC 55111-186-05 Unit dose package of 100 (10 x 10) NDC 55111-186-78
QUETIAPINE FUMARATE tablets 150 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘188’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-188-30 Bottles of 60 NDC 55111-188-60 Bottles of 100 NDC 55111-188-01 Bottles of 500 NDC 55111-188-05 Unit dose package of 100 (10 x 10) NDC 55111-188-78
QUETIAPINE FUMARATE tablets 200 mg are white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘5’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-189-30 Bottles of 60 NDC 55111-189-60 Bottles of 100 NDC 55111-189-01 Bottles of 500 NDC 55111-189-05 Unit dose package of 100 (10 x 10) NDC 55111-189-78
QUETIAPINE FUMARATE tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘6’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-190-30 Bottles of 60 NDC 55111-190-60 Bottles of 100 NDC 55111-190-01 Bottles of 500 NDC 55111-190-05 Unit dose package of 100 (10 x 10) NDC 55111-190-78
QUETIAPINE FUMARATE tablets 400 mg are yellow colored, capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘7’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-606-30 Bottles of 60 NDC 55111-606-60 Bottles of 100 NDC 55111-606-01 Bottles of 500 NDC 55111-606-05 Unit dose package of 100 (10 x 10) NDC 55111-606-78 Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]
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