Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)
Aurobindo Pharma Limited
QUETIAPINE FUMARATE
QUETIAPINE 50 mg
ORAL
PRESCRIPTION DRUG
Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with Seroquel [see Clinical Studies (14.1) ] . Quetiapine extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of quetiapine extended-release tablets in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar I disorder as well as on
Quetiapine Extended-Release Tablets, USP 50 mg are peach, film-coated, capsule shaped, biconvex, tablet debossed with “Z45” on one side and plain on the other side. Bottles of 60 NDC 65862-873-60 Bottles of 100 NDC 65862-873-01 Bottles of 500 NDC 65862-873-05 Quetiapine Extended-Release Tablets, USP 150 mg are white, film-coated, capsule shaped, biconvex, tablet debossed with “Z46” on one side and plain on the other side. Bottles of 60 NDC 65862-874-60 Bottles of 100 NDC 65862-874-01 Bottles of 500 NDC 65862-874-05 Quetiapine Extended-Release Tablets, USP 200 mg are yellow, film-coated, capsule shaped, biconvex, tablet debossed with “Z47” on one side and plain on the other side. Bottles of 60 NDC 65862-875-60 Bottles of 100 NDC 65862-875-01 Bottles of 500 NDC 65862-875-05 Quetiapine Extended-Release Tablets, USP 300 mg are pale yellow, film-coated, capsule shaped, biconvex, tablet debossed with “Z48” on one side and plain on the other side. Bottles of 60 NDC 65862-876-60 Bottles of 100 NDC 65862-876-01 Bottles of 500 NDC 65862-876-05 Quetiapine Extended-Release Tablets, USP 400 mg are white, film-coated, capsule shaped, biconvex, tablet debossed with “Z49” on one side and plain on the other side. Bottles of 60 NDC 65862-877-60 Bottles of 100 NDC 65862-877-01 Bottles of 500 NDC 65862-877-05 Store quetiapine extended-release tablets, USP at 20o to 25ºC (68o to 77ºF) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
QUETIAPINE FUMARATE - QUETIAPINE TABLET, FILM COATED, EXTENDED RELEASE Aurobindo Pharma Limited ---------- MEDICATION GUIDE Quetiapine Extended-Release Tablets, USP (kwe tye' a peen) Read this Medication Guide before you start taking quetiapine extended-release tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about quetiapine extended-release tablets? Quetiapine extended-release tablets may cause serious side effects, including: 1. risk of death in the elderly with dementia: Medicines like quetiapine extended-release tablets can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine extended- release tablets are not for treating psychosis in the elderly with dementia. 2. risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions). Talk to your or your family member’s, healthcare provider about: • all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or suicidal thoughts or actions. • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressa Olvassa el a teljes dokumentumot
QUETIAPINE FUMARATE - QUETIAPINE TABLET, FILM COATED, EXTENDED RELEASE AUROBINDO PHARMA LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QUETIAPINE EXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUETIAPINE EXTENDED-RELEASE TABLETS. QUETIAPINE EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. QUETIAPINE EXTENDED-RELEASE TABLETS ARE NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1) SUICIDAL THOUGHTS AND BEHAVIORS INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN CHILDREN, ADOLESCENTS AND YOUNG ADULTS TAKING ANTIDEPRESSANTS. (5.2) MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. (5.2) INDICATIONS AND USAGE Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder, manic, or mixed episodes (1.2) Bipolar disorder, depressive episodes (1.2) Major depressive disorder, adjunctive therapy with antidepressants (1.3) DOSAGE AND ADMINISTRATION Swallow tablets whole and do not split, chew or crush (2.1) Take without food or with a light meal (approx. 300 calories) (2.1) Administer once daily, preferably in the evening (2.1) _Geriatric Use: _Consider a lower starting dose (50 mg/day), slower titration, and careful monitoring during the initial dosing period in the elderly. (2.3, 8.5) _Hepatic Impairment: _Lower starting dose (50 mg/day) and slower titration may be needed (2.4, 8.7, 12.3) INDICATION INITIAL DOSE RECOMMENDED DOSE MAXIMUM DOSE Schizophrenia - Adults (2.2) 300 mg/day 400 to 800 mg/day 800 mg/day Sc Olvassa el a teljes dokumentumot