Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)
Golden State Medical Supply, Inc.
QUETIAPINE FUMARATE
QUETIAPINE 25 mg
ORAL
PRESCRIPTION DRUG
Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). The effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies ( 14.1) ]. Quetiapine tablets are 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 tablets are indicated as monotherapy for the acute treatment of depressive episodes associated wi
Quetiapine tablets, USP Quetiapine tablets, USP 25 mg are peach, round, biconvex, film coated tablets. Engraved with 'APO' on one side and "QUE’ over ‘25’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-413-01) Bottles of 1,000 (NDC 60429-413-10) Quetiapine tablets, USP 50 mg are white, round, biconvex, film coated tablets. Engraved with 'APO' on one side and ‘QUE’ over ‘50’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-414-01) Bottles of 1,000 (NDC 60429-414-10) Quetiapine tablets, USP 100 mg are yellow, round, biconvex film coated tablets. Engraved with 'APO' on one side and ‘QUE’ over ‘100’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-415-01) Bottles of 1,000 (NDC 60429-415-10) Quetiapine tablets, USP 200 mg are white, round, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE’ over ‘200’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-416-01) Bottles of 1,000 (NDC 60429-416-10) Quetiapine tablets, USP 300 mg are white, capsule-shaped, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE300’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-417-01) Bottles of 1,000 (NDC 60429-417-10) Quetiapine tablets, USP 400 mg are yellow, capsule-shaped, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE 400’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-418-01) Bottles of 1,000 (NDC 60429-418-10) Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15°C to 30ºC (59°F to 86ºF) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED Golden State Medical Supply, Inc. ---------- Medication Guide Quetiapine Tablets, USP (kwe-TYE-a-peen FUE-ma-rate) Read this Medication Guide before you start taking quetiapine fumarate 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 Fumarate Tablets? Quetiapine fumarate tablets may cause serious side effects, including: 1. risk of death in the elderly with dementia. Medicines like quetiapine fumarate tablets can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine fumarate 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 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 Прочитайте повний документ
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED GOLDEN STATE MEDICAL SUPPLY, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION QUETIAPINE TABLETS 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 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 IS 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) RECENT MAJOR CHANGES Warnings and Precautions, Leukopenia, Neutropenia and Agranulocytosis ( 5.10) 11/2018 Warnings and Precautions, Anticholinergic (antimuscarinic) Effects ( 5.20) 11/2018 INDICATIONS AND USAGE Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia ( 1.1) Bipolar I disorder manic episodes ( 1.2) Bipolar disorder, depressive episodes ( 1.2) 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 150-750 mg/day 750 mg/day Schizophrenia-Adolescents (13-17years) (2.2) 25 mg twice daily 400-800 mg/day 800 mg/day Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily 400-800 mg/day 800 mg/day Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2) 25 mg twice daily 400-600 mg/day 600 mg/day Bipolar Depression-Adults ( Прочитайте повний документ