quetiapine 400 mg
1 INDICATIONS & 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 is indicated for the treatment of Schizophrenia. The efficacy of quetiapine 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 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 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 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 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 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.
Ascend Laboratories, LLC
CAPSULE YELLOW 336
Related Pills
quetiapine 300 mg
ascend laboratories, llc
quetiapine 25 mg
Ascend Laboratories, LLC
quetiapine 200 mg
ascend laboratories, llc
quetiapine 50 mg
ascend laboratories, llc
quetiapine 100 mg
ascend laboratories, llc
butalbital acetaminophen and caffeine tablet
actavis pharma, inc.
butalbital acetaminophen and caffeine tablet
Actavis Pharma, Inc.
butalbital acetaminophen and caffeine tablet
Actavis Pharma, Inc.
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 Quetiapine tablets, USP 25 mg peach coloured, film coated, round shape, biconvex tablets, debossed with "262 ” on one side and plain on other side. Bottles of 100 tablets NDC 67877-242-01 Bottles of 1000 tablets NDC 67877-242-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-242-38 Carton pack of 10 tablets (1 x 10’s blister pack) NDC 67877-242-33 Quetiapine tablets, USP 50 mg white coloured, film coated, round shape, biconvex tablets, debossed with"337" on one side and plain on other side. Bottles of 100 tablets NDC 67877-249-01 Bottles of 1000 tablets NDC 67877-249-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-249-38 Carton pack of 10 tablets (1 x 10’s blister pack) NDC 67877-249-33 Quetiapine tablets, USP 100 mg yellow coloured, film coated, round shape, biconvex tablets, debossed with "261" on one side and plain on other side. Bottles of 100 tablets NDC 67877-250-01 Bottles of 1000 tablets NDC 67877-250-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-250-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-250-33 Quetiapine tablets, USP 150 mg Off white to light yellow coloured, film coated, round shape, biconvex tablets, debossed with "353" on one side and plain on other side. Bottles of 100 tablets NDC 67877-245- 01 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-245-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-245-33 Quetiapine tablets, USP 200 mg white coloured, film coated, round shape, biconvex tablets, debossed with "260" on one side and plain on other side. Bottles of 100 tablets NDC 67877-246- 01 Bottles of 1000 tablets NDC 67877-246-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-246-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-246-33 Quetiapine tablets, USP 300 mg white coloured, film coated, capsule shaped, biconvex tablets, debossed with "259" on one side and plain on other side. Bottles of 60 tablets NDC 67877-247- 60 Bottles of 1000 tablets NDC 67877-247-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-247-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-247-33 Quetiapine tablets, USP 400 mg yellow coloured, film coated, capsule shaped, biconvex tablets, debossed with "336" on one side and plain on other side. Bottles of 100 tablets NDC 67877-248- 01 Bottles of 1000 tablets NDC 67877-248-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-248-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-248-33 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
More pills like CAPSULE 336