QUETIAPINE FUMARATE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Avera McKennan Hospital

INN (Jina la Kimataifa):

QUETIAPINE FUMARATE

Tungo:

QUETIAPINE 400 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)]. Quetiapine is 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 is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studie

Bidhaa muhtasari:

Quetiapine Tablets USP 400 mg tablets are supplied as a white to off-white, oval, standard biconvex tablet debossed with product identification “54 735” on one side and plain on the other side. NDC 0054-0230-25: Bottle of 100 Tablets NDC 0054-0230-20: 10x10 Unit-Dose Tablets NDC 69189-0495-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
Avera McKennan Hospital
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MEDICATION GUIDE
Quetiapine Tablets USP
(kwe tye ’a peen)
Rx only
Read this Medication Guide before you start taking quetiapine 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?
Quetiapine may cause serious side effects, including:
1.
Risk of death in the elderly with dementia. Medicines like quetiapine
can increase the risk of death
in elderly people who have memory loss (dementia). Quetiapine 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:
o
all risks and benefits of treatment with antidepressant medicines
o
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?
o
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts,
or feelings. This is very important when an antidepressant medicine is
started or when the
dose is changed
o
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or fe

Tabia za bidhaa

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
AVERA MCKENNAN HOSPITAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUETIAPINE TABLETS.
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
•
SUICIDAL THOUGHTS AND BEHAVIORS
•
•
INDICATIONS AND USAGE
Quetiapine is an atypical antipsychotic indicated for the treatment
of:
•
•
•
DOSAGE AND ADMINISTRATION
•
INDIC ATIO N
INITIAL DOSE
RECOMMENDED DOSE
MAXIMUM DOSE
Schizophrenia-Adults (2.2)
25 mg twice daily
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents
(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 daily
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults (2.2)
50 mg once daily at bedtime
300 mg/day
300 mg/day
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to quetiapine 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 TABLETS ARE NOT APPROVED FOR
ELDERLY PATIENTS WITH DEMENTIA-
RELATED PSYCHOSIS. (5.1)
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)
Schizophrenia (1.1)
Bipolar I disorder manic episodes (1.2)
Bipolar disord