QUETIAPINE FUMARATE- quetiapine tablet, film coated, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Aurobindo Pharma Limited

INN (International Nazwa):

QUETIAPINE FUMARATE

Skład:

QUETIAPINE 50 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 to 17 years) treated with Seroquel [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 as on

Podsumowanie produktu:

Quetiapine Extended-Release Tablets, USP 50 mg are peach, film-coated, capsule shaped, biconvex, tablet debossed with “Z45” on one side and plain on the other side.         Bottles of 60               NDC 65862-873-60         Bottles of 100             NDC 65862-873-01         Bottles of 500             NDC 65862-873-05 Quetiapine Extended-Release Tablets, USP 150 mg are white, film-coated, capsule shaped, biconvex, tablet debossed with “Z46” on one side and plain on the other side.         Bottles of 60               NDC 65862-874-60         Bottles of 100             NDC 65862-874-01         Bottles of 500             NDC 65862-874-05 Quetiapine Extended-Release Tablets, USP 200 mg are yellow, film-coated, capsule shaped, biconvex, tablet debossed with “Z47” on one side and plain on the other side.         Bottles of 60               NDC 65862-875-60         Bottles of 100             NDC 65862-875-01         Bottles of 500             NDC 65862-875-05 Quetiapine Extended-Release Tablets, USP 300 mg are pale yellow, film-coated, capsule shaped, biconvex, tablet debossed with “Z48” on one side and plain on the other side.         Bottles of 60               NDC 65862-876-60         Bottles of 100             NDC 65862-876-01         Bottles of 500             NDC 65862-876-05 Quetiapine Extended-Release Tablets, USP 400 mg are white, film-coated, capsule shaped, biconvex, tablet debossed with “Z49” on one side and plain on the other side.         Bottles of 60               NDC 65862-877-60         Bottles of 100             NDC 65862-877-01         Bottles of 500             NDC 65862-877-05 Store quetiapine extended-release tablets, USP at 20o to 25ºC (68o to 77ºF) [see USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

QUETIAPINE FUMARATE - QUETIAPINE TABLET, FILM COATED, EXTENDED RELEASE
Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Quetiapine Extended-Release Tablets, USP
(kwe tye' a 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:
•
all risks and benefits of treatment with antidepressant medicines
•
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?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. This is very important when an antidepressa

Charakterystyka produktu

QUETIAPINE FUMARATE - QUETIAPINE TABLET, FILM COATED, EXTENDED RELEASE
AUROBINDO PHARMA LIMITED
----------
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 tablets are 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
Sc