QUETIAPINE FUMARATE tablet, extended release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)

Disponible des:

Ingenus Pharmaceuticals, LLC

Designació comuna internacional (DCI):

QUETIAPINE FUMARATE

Composición:

QUETIAPINE 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with quetiapine tablets [see Clinical Studies (14.1)]. Quetiapine extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of quetiapine extended-release tablets in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar I disorder as well

Resumen del producto:

Store quetiapine extended-release tablets, USP at 25 ºC (77 ºF); excursions permitted to 15-30 ºC (59-86 ºF) [See USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
Ingenus Pharmaceuticals, LLC
----------
Medication Guide for quetiapine extended-release tablets
(kweh-TYE-uh-peen)
Read this Medication Guide before you start taking quetiapine
extended-release tablets and each time you
get a refill. There may be new information. This Medication Guide does
not take the place of talking to
your healthcare provider about your medical condition or treatment.
What is the most important information I should know about quetiapine
extended-release tablets?
Quetiapine extended-release tablets may cause serious side effects,
including:
1. risk of death in the elderly with dementia: Medicines like
quetiapine extended-release tablets can
increase the risk of death in elderly people who have memory loss
(dementia). Quetiapine extended-
release 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:
o all risks and benefits of treatment with antidepressant medicines
o all treatment choices for depression or other serious mental illness
• Antidepressant medicines 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?
o Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant m

Fitxa tècnica

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
INGENUS PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR QUETIAPINE
EXTENDED-RELEASE TABLETS.
QUETIAPINE EXTENDED RELEASE 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 EXTENDED-RELEASE TABLETS
ARE 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)
INDICATIONS AND USAGE
Quetiapine extended-release tablet is an atypical antipsychotic
indicated for the treatment of:
Schizophrenia (1.1)
Bipolar I disorder, manic, or mixed episodes (1.2)
Bipolar disorder, depressive episodes (1.2)
Major depressive disorder, adjunctive therapy with antidepressants
(1.3)
DOSAGE AND ADMINISTRATION
Swallow tablets whole and do not split, chew or crush (2.1)
Take without food or with a light meal (approx. 300 calories) (2.1)
Administer once daily, preferably in the evening (2.1)
_Geriatric Use:_ Consider a lower starting dose (50 mg/day), slower
titration, and careful monitoring
during the initial dosing period in the elderly. (2.3 ,8.5 )
_Hepatic Impairment:_ Lower starting dose (50 mg/day) and slower
titration may be needed (2.4 ,8.7
,12.3 )
Indication
Initial Dose
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.2)
300 mg/day
400 to 800 mg/day
800 mg/day
Schiz