País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)
Aphena Pharma Solutions - Tennessee, LLC
QUETIAPINE FUMARATE
QUETIAPINE 25 mg
ORAL
PRESCRIPTION DRUG
Quetiapine tablets, USP 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 to 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, 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 disorder. Efficacy was established in two 8-week monotherapy trials
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 1000 (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 1000 (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 1000 (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 1000 (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 1000 (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 1000 (NDC 60429-418-10) Store at 20º to 25ºC (68º to 77ºF); excursions permitted from 15 to 30ºC (59 to 86ºF) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED Aphena Pharma Solutions - Tennessee, LLC ---------- 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: What else do I need to know about antidepressant medicines? 1. all risks and benefits of treatment with antidepressant medicines 2. 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? Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, Llegiu el document complet
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QUETIAPINE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUETIAPINE TABLETS, USP. 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 1. SUICIDAL THOUGHTS AND BEHAVIORS 1. 2. RECENT MAJOR CHANGES Warnings and Precautions, Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia- Related Psychosis (5.3) 4/2013 INDICATIONS AND USAGE Quetiapine tablets, USP are an atypical antipsychotic indicated for the treatment of: 1. 2. 3. DOSAGE AND ADMINISTRATION Quetiapine tablets, USP can be taken with or without food (2.1) INDIC ATIO N INITIAL DOSE RECOMMENDED DOSE MAXIMUM DOSE Schizophrenia-Adults (2.2) 25 mg twice daily 150 - 750 mg/day 750 mg/day Schizophre nia-Adole sce nts (13-17years) (2.2) 25 mg twicedaily 400 - 800 mg/day 800 mg/day Bipolar Mania- AdultsMonotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily 400 - 800 mg/day 800 mg/day Bipolar Mania-Children andAdolescents (10 to 17years), Monotherapy(2.2) 25 mg twice daily 400 - 600 mg/day 600 mg/day Bipolar Depression-Adults (2.2) 50 mg once daily at bedtime 300 mg/day 300 mg/day 1. 2. DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg (3) CONTRAINDICATIONS Known hypersensitivity to quetiapine fumarate tablets 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. QUETIAPINE IS NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ( Llegiu el document complet