Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)
STAT RX USA LLC
QUETIAPINE FUMARATE
QUETIAPINE FUMARATE 100 mg
ORAL
PRESCRIPTION DRUG
SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6–week trial in adolescents (13–17 years). The effectiveness of SEROQUEL for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)]. SEROQUEL 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 (10-17 years) [see Clinical Studies (14.2)]. SEROQUEL 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.
25 mg Tablets (NDC 0310-0275) peach, round, biconvex, film coated tablets, identified with 'SEROQUEL' and ‘25’ on one side and plain on the other side, are supplied in bottles of 100 tablets and 1000 tablets, and hospital unit dose packages of 100 tablets. 50 mg Tablets (NDC 0310-0278) white, round, biconvex, film coated tablets, identified with 'SEROQUEL' and ‘50’ on one side and plain on the other side, are supplied in bottles of 100 tablets and 1000 tablets, and hospital unit dose packages of 100 tablets. 100 mg Tablets (NDC 0310-0271) yellow, round, biconvex film coated tablets, identified with 'SEROQUEL' and ‘100’ on one side and plain on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets. 200 mg Tablets (NDC 0310-0272) white, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘200’ on one side and plain on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets. 300 mg Tablets (NDC 0310-0274) white, capsule-shaped, biconvex, film coated tablets, intagliated with ‘SEROQUEL’ on one side and ‘300’ on the other side, are supplied in bottles of 60 tablets, and hospital unit dose packages of 100 tablets. 400 mg Tablets (NDC 0310-0279) yellow, capsule-shaped, biconvex, film coated tablets, intagliated with ‘SEROQUEL’ on one side and ‘400’ on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets. Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP].
New Drug Application
SEROQUEL - QUETIAPINE FUMARATE TABLET, FILM COATED STAT RX USA LLC ---------- SPL MEDGUIDE SECTION MEDICATION GUIDE SEROQUEL (SER-oh-kwell) (quetiapine fumarate) Tablets Read this Medication Guide before you start taking SEROQUEL 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? Serious side effects may happen when you take SEROQUEL, including • Risk of death in the elderly with dementia: Medicines like SEROQUEL can raise the risk of death in elderly people who have lost touch with reality due to confusion and memory loss (dementia). SEROQUEL is not approved for treating psychosis in the elderly with dementia. • Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions: 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. 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. 3. 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 antidepressant medicine is started or when the dose is changed. • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, Perskaitykite visą dokumentą
SEROQUEL - QUETIAPINE FUMARATE TABLET, FILM COATED STAT RX USA LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SEROQUEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEROQUEL. SEROQUEL (QUETIAPINE FUMARATE) TABLETS INITIAL U.S. APPROVAL: 1997 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ ANTIPSYCHOTIC DRUGS ARE ASSOCIATED WITH AN INCREASED RISK OF DEATH (5.1) QUETIAPINE IS NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (5.1) WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE_ _BOXED WARNING._ INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN, ADOLESCENTS AND YOUNG ADULTS TAKING ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER AND OTHER PSYCHIATRIC DISORDERS (5.2) RECENT MAJOR CHANGES Warnings and Precautions, Hyperglycemia (5.4), 1/2011 Warnings and Precautions, Hyperlipidemia (5.5), 1/2011 Warnings and Precautions, Weight Gain (5.6), 1/2011 Warnings and Precautions, Hypothyroidism (5.13), 1/2011 Warnings and Precautions, Withdrawal (5.22), 5/2010 INDICATIONS AND USAGE SEROQUEL is an atypical antipsychotic indicated for the: (1) Treatment of schizophrenia (1.1) (1) Adults: Efficacy was established in three 6–week clinical trials in patients with schizophrenia (14.1) Adolescents (ages 13–17): Efficacy was established in one 6–week trial in patients with schizophrenia (14.1) (1) Acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex (1.2) (1) Adults: Efficacy was established in two 12–week monotherapy trials and in one 3–week adjunctive trial in patients with manic episodes associated with bipolar I disorder (14.2) (1) Children and Adolescents (ages 10–17): Efficacy was established in one 3–week monotherapy trial in patients with manic episodes associated with bipolar I disord Perskaitykite visą dokumentą