Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)
Avera McKennan Hospital
QUETIAPINE FUMARATE
QUETIAPINE 300 mg
ORAL
PRESCRIPTION DRUG
SEROQUEL XR is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL XR 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 (13-17 years) treated with SEROQUEL [see Clinical Studies (14.1)]. SEROQUEL XR is 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 SEROQUEL XR 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 one 3-week monotherapy trial in children and adolescents (10 – 17 years) with manic episodes associated
300 mg Tablets (NDC 0310-0283) pale yellow, film coated, capsule-shaped, biconvex, intagliated tablet with “XR 300” on one side and plain on the other are supplied in bottles of 60 tablets and hospital unit dose packages of 100 tablets.NDC 69189-0484-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital Store SEROQUEL XR at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP].
New Drug Application
SEROQUEL XR- QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE Avera McKennan Hospital ---------- MEDICATION GUIDE SEROQUEL XR (SER-oh-kwell X-R) (quetiapine fumarate) Extended-Release Tablets Read this Medication Guide before you start taking SEROQUEL XR 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 SEROQUEL XR? SEROQUEL XR may cause serious side effects, including: 1. risk of death in the elderly with dementia: Medicines like SEROQUEL XR can increase the risk of death in elderly people who have memory loss (dementia). SEROQUEL XR is 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: o all risks and benefits of treatment with antidepressant medicines o 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? o Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. o Call the healthcare provider right away to report new or sudden chan Preberite celoten dokument
SEROQUEL XR- QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SEROQUEL XR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEROQUEL XR. SEROQUEL XR (QUETIAPINE FUMARATE) 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 • SUICIDAL THOUGHTS AND BEHAVIORS • • RECENT MAJOR CHANGES Warnings and Precautions, Falls (5.8) 02/2017 INDICATIONS AND USAGE SEROQUEL XR is an atypical antipsychotic indicated for the treatment of: • • • • DOSAGE AND ADMINISTRATION • • • • • INDIC ATIO N I NITIAL DO SE RECO MMENDED DO SE MAXIMUM DOSE Schizophrenia- Adults (2.2) 300 mg/day 400-800 mg/day 800 mg/day Schizophrenia-Adolescents (13 to 17 years) (2.2) 50 mg/day 400-800 mg/day 800 mg/day Bipolar I Disorder manic or mixed-Acute monotherapy or adjunct to lithium or divalproex-Adults (2.2) 300 mg/day 400-800 mg/day 800 mg/day Bipolar I Disorder, manic Acute monotherapy -Children and Adolescents (10 to 17 years) (2.2) 50 mg/day 400-600 mg/day 600 mg/day Bipolar Disorder, Depressive Episodes-Adults (2.2) 50 mg/day 300 mg/day 300 mg/day Major Depressive Disorder, Adjunctive Therapy with Antidepressants- Adults (2.2) 50 mg/day 150-300 mg/day 300 mg/day DOSAGE FORMS AND STRENGTHS Extended-Release Tablets: 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg (3) CONTRAINDICATIONS Known hypersensitivity to SEROQUEL XR or any components in the formulation (4) WARNINGS AND PRECAUTIONS • ® ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. SEROQUEL XR IS NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (5.1) INCREASED RISK OF SUICIDAL THOUGHT Preberite celoten dokument