quetiapine fumarate tablet
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 .
Sandoz Inc
ROUND WHITE SZ 232
SZ 232 ROUND WHITE
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING 25 mg, light brown, round shaped, biconvex tablets, with "SZ" debossed on one side and "230" on the other side. NDC 0781-5343-01, bottle of 100 tablets 50 mg, white, round shaped, biconvex tablets, with "SZ" debossed on one side and "200" on the other side. NDC 0781-5342-01, bottle of 100 tablets 100 mg, yellow, round shaped, biconvex tablets, with "SZ" debossed on one side and "231" on the other side. NDC 0781-5344-01, bottle of 100 tablets 150 mg, light brown, round shaped, biconvex tablets, with "SZ" debossed on one side and "269" on the other side. NDC 0781-5345-01, bottle of 100 tablets 200 mg, white, round shaped, biconvex tablets, with "SZ" debossed on one side and "232" on the other side. NDC 0781-5346-01, bottle of 100 tablets 300 mg, white, capsule shaped, biconvex tablets, with "SZ" debossed on one side and "233" on the other side. NDC 0781-5347-01, bottle of 100 tablets 400 mg, yellow, capsule shaped, biconvex tablets, with "SZ" debossed on one side and "267" on the other side. NDC 0781-5348-01, bottle of 100 tablets Store at 20° to 25º C (68° to 77° F) [see USP Controlled Room Temperature].
More pills like ROUND SZ 232