Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Quetiapine tablets USP are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets USP 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 USP for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES ( 14.1 )]. Quetiapine tablets USP 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 USP are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar di
Quetiapine tablets USP , 25 mg (as quetiapine) are pink colored, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y15" on the other side, which are supplied as follows: NDC 68180-445-01 Bottle of 100s NDC 68180-445-03 Bottle of 1000s NDC 68180-445-13 Unit Dose Blisters of 10 x 10s Quetiapine tablets USP , 50 mg (as quetiapine) are white, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y16" on the other side, which are supplied as follows: NDC 68180-446-01 Bottle of 100s NDC 68180-446-03 Bottle of 1000s NDC 68180-446-13 Unit Dose Blisters of 10 x 10s Quetiapine tablets USP, 100 mg (as quetiapine) are yellow colored, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y17" on the other side, which are supplied as follows: NDC 68180-447-01 Bottle of 100s NDC 68180-447-03 Bottle of 1000s NDC 68180-447-13 Unit Dose Blisters of 10 x 10s Quetiapine tablets USP, 200 mg (as quetiapine) are white, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y18" on the other side, which are supplied as follows: NDC 68180-448-01 Bottle of 100s NDC 68180-448-02 Bottle of 500s NDC 68180-448-03 Bottle of 1000s NDC 68180-448-13 Unit Dose Blisters of 10 x 10s Quetiapine tablets USP, 300 mg (as quetiapine) are white, capsule shape, biconvex, film-coated tablets, debossed "LU" on one side and "Y19" on the other side, which are supplied as follows: NDC 68180-449-07 Bottle of 60s NDC 68180-449-01 Bottle of 100s NDC 68180-449-02 Bottle of 500s NDC 68180-449-03 Bottle of 1000s NDC 68180-449-13 Unit Dose Blisters of 10 x 10s Quetiapine tablets USP, 400 mg (as quetiapine) are yellow colored, capsule shape, biconvex, film-coated tablets, debossed "LU" on one side and "Y20" on the other side, which are supplied as follows: NDC 68180-450-01 Bottle of 100s NDC 68180-450-02 Bottle of 500s NDC 68180-450-03 Bottle of 1000s NDC 68180-450-13 Unit Dose Blisters of 10 x 10s Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET REMEDYREPACK INC. ---------- MEDICATION GUIDE Quetiapine (kwe-TYE-a-peen) Tablets USP 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 can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine 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 changed. • Call the healthcare provider right away to report new or sudden changes in mood, Les hele dokumentet
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET REMEDYREPACK 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 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 fumarate tablet USP is 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 fumarate tablets USP can be taken with or without food ( 2.1). INDICATION INITIAL DOSE RECO MMENDED DOSE MAXIMUM DOSE Schizophrenia-Adults ( 2.2) 25 mg twice daily 150 to 750 mg/day 750 mg/day Schizophrenia-Adolescents (13 to 17 years) ( 2.2) 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 years), Monotherapy ( 2.2) 25 mg twice daily 400 to 600 mg/day 600 mg/day Bipolar Depre Les hele dokumentet