מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)
Preferred Pharmaceuticals, Inc.
QUETIAPINE FUMARATE
QUETIAPINE 200 mg
ORAL
PRESCRIPTION DRUG
Quetiapine tablet is 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)]. Quetiapine tablet 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)] . Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, a
200 mg Tablets (NDC 16729-148) white to off white, round, biconvex, film coated tablet, debossed ‘200’ on one side and plain on other side, are supplied as follow: Bottle of 30 - 68788-9487-3 Bottle of 60 - 68788-9487-6 Bottle of 90 - 68788-9487-9 Bottle of 100 - 68788-9487-1 Bottle of 120 - 68788-9487-8 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP].
Abbreviated New Drug Application
QUETIAPINE FUMARATE- quetiapine fumarate tablet, film coated Preferred Pharmaceuticals, Inc. ---------- Medication Guide Quetiapine Tablets (kwe-TYE-a-peen) Read this Medication Guide before you start taking quetiapine tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about quetiapine tablets? Quetiapine tablets may cause serious side effects, including: 1. risk of death in the elderly with dementia: Medicines like quetiapine tablets can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine tablet 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: • all risks and benefits of treatment with antidepressant medicines. • all treatment choices for depression or other serious mental illness. Antidepressant medications 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 antidepressant medicine is started or when the dose is changed. Call the healthcare provider right away to report new or sudden changes in קרא את המסמך השלם
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED PREFERRED PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QUETIAPINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUETIAPINE TABLETS. QUETIAPINE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS SUICIDAL THOUGHTS AND BEHAVIORS RECENT MAJOR CHANGES 9/2020 INDICATIONS AND USAGE Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: • • • DOSAGE AND ADMINISTRATION Quetiapine tablets can be taken with or without food ( 2.1). INDICATION INITIAL DOSE RECOMMENDED DOSE MAXIMUM DOSE Schizophrenia-Adults ( 2.2) 25 mg twice daily 150 to 750 mg/day 750 mg/day 25 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex ( 2.2) 50 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania- Children and Adolescents (10 to 17 25 mg twice daily 400 to 600 mg/day 600 mg/day WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS _See full prescribing information for complete boxed warning._ ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. QUETIAPINE IS NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ( 5.1) 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) Warnings and Precautions ( 5.20) Schizophrenia ( 1.1) Bipolar I disorder manic episodes ( 1.2) Bipolar disorder, depressive episodes ( 1.2) Schizophrenia- Adolescents (13 to 17 years) ( 2.2 ) and Adolescents (10 to 17 years), Monotherapy ( 2.2) Bipolar Depression-Adults ( 2.2) 50 mg once daily at bedtime 300 mg/day 300 mg/day • • DOSAGE FORMS AND STRENGT קרא את המסמך השלם