QUETIAPINE FUMARATE- quetiapine fumarate tablet, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

REMEDYREPACK INC.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Quetiapine fumarate extended-release tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate extended-release tablet 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 quetiapine fumarate tablet [see CLINICAL STUDIES ( 14.1)] Quetiapine fumarate extended-release tablet is 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 fumarate extended-release tablet 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 ass

Prehľad produktov:

    •    50 mg Tablets are peach to red colored, capsule shaped, biconvex, film coated tablets debossed with "LU" on one side and "K71" on the other side         Bottle of 60 tablets (NDC 68180-612-07).         Bottle of 100 tablets (NDC 68180-612-01).     •    150 mg Tablets are white colored, capsule shaped, biconvex, film coated tablets debossed with "LU" on one side and "K72" on the other side         Bottle of 60 tablets (NDC 68180-613-07).         Bottle of 100 tablets (NDC 68180-613-01).     •    200 mg Tablets are yellow colored, capsule shaped, biconvex, film coated tablets debossed with "LU" on one side and "K73" on the other side         Bottle of 60 tablets (NDC 68180-614-07).         Bottle of 100 tablets (NDC 68180-614-01).     •    300 mg Tablets are pale yellow colored, capsule shaped, biconvex, film coated tablets debossed with "LU" on one side and "K74" on the other side         Bottle of 60 tablets (NDC 68180-615-07).         Bottle of 100 tablets (NDC 68180-615-01).     •    400 mg Tablets are white colored, capsule shaped, biconvex, film coated tablets debossed with "LU" on one side and "K75" on the other side         Bottle of 60 tablets (NDC 68180-616-07).         Bottle of 100 tablets (NDC 68180-616-01). Store quetiapine fumarate extended-release tablets at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [see USP Controlled Room Temperature].

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
REMEDYREPACK INC.
----------
Quetiapine Fumarate Extended-Release Tablet
(kweh-TYE-uh-peen)
Read this Medication Guide before you start taking quetiapine fumarate
extended-release tablet 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
fumarate extended-release tablet?
Quetiapine fumarate extended-release tablet may cause serious side
effects, including:
1 Risk of death in the elderly with dementia: Medicines like
quetiapine fumarate extended-release
tablet can increase the risk of death in elderly people who have
memory loss (dementia). Quetiapine
fumarate extended-release tablet is 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 a

Súhrn charakteristických

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE FUMARATE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR QUETIAPINE FUMARATE
EXTENDED-RELEASE TABLETS.
QUETIAPINE FUMARATE 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 FUMARATE EXTENDED-RELEASE TABLET 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)
INDICATIONS AND USAGE
Quetiapine fumarate 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)
INDIC ATIO N INITIAL
DO SE
RECO MMENDED
DO SE
MAXIMUM
DO SE
Schizophre nia-
A