Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)
NCS HealthCare of KY, Inc dba Vangard Labs
QUETIAPINE FUMARATE
QUETIAPINE 100 mg
ORAL
PRESCRIPTION DRUG
Quetiapine Fumarate 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 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 Fumarate 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 Fumarate Tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8 week monoth
Quetiapine Fumarate Tablets are available as follows: 25 mg – light orange, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “V7” on the other side, in blisterpacks of 30 (NDC 0615-7846-39) and 15 (NDC 0615-7846-05) and unit-dose boxes of 30 (0615-7846-30). 50 mg – white to off-white, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8166” on the other side. 100 mg – light orange, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8162” on the other side, in blisterpacks of 30 (NDC 0615-7725-39) and 15 (NDC 0615-7725-05). 200 mg – white to off-white, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8163” on the other side, in blisterpacks of 30 (NDC 0615-7726-39). 300 mg – pale yellow, capsule-shaped, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8164” on the other side, in blisterpacks of 30 (NDC 0615-7727-39). 400 mg – white to off-white, capsule-shaped, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8165” on the other side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED NCS HealthCare of KY, Inc dba Vangard Labs ---------- MEDICATION GUIDE Quetiapine Fumarate (kwe-TYE-a-peen FUE-ma-rate) Tablets 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: • oall risks and benefits of treatment with antidepressant medicines. • oall 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? • oPay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medic Διαβάστε το πλήρες έγγραφο
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QUETIAPINE FUMARATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE 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 FUMARATE 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, Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia- Related Psychosis (5.3) 4/2013 INDICATIONS AND USAGE Quetiapine Fumarate 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 fumarate tablets can be taken with or without food (2.1) INDIC ATIO N INITIAL DOSE RECO MMENDED DO SE MAXIMUM DOSE Schizophrenia-Adults (2.2) 25 mg twice daily 150 to 750 mg/day 750 mg/day Schizophre nia-Adole sce nts (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 dail Διαβάστε το πλήρες έγγραφο