QUETIAPINE FUMARATE tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

STAT Rx USA LLC

SNN (starptautisko nepatentēto nosaukumu):

QUETIAPINE FUMARATE

Kompozīcija:

QUETIAPINE 50 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Quetiapine fumarate tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6- week trials in adults. 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 )]. Pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. Quetiapine fumarate tablet 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. [see Clinical

Produktu pārskats:

50 mg Tablets white to off white, round, biconvex, film coated tablet, debossed ‘50’ on one side and plain on other side, are supplied in bottles of 30 tablets (NDC 42549-674-30), 60 tablets (NDC 42549-674-60) and 90 tablets (NDC 42549-674-90). Store at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [See USP].

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
STAT Rx USA LLC
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SPL MEDGUIDE SECTION
MEDICATION GUIDE
Quetiapine fumarate 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 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 tablets? Quetiapine
fumarate tablets may cause serious side effects, including
1.
Risk of death in the elderly with dementia
2.
Risk of suicidal thoughts or actions
3.
High blood sugar (hyperglycemia)
4.
High fat levels in your blood (increased cholesterol and
triglycerides)
5.
Weight gain
These serious side effects are described below:
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 tablet
is not approved 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 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 th

Produkta apraksts

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
STAT RX USA LLC
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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
INITIAL U.S. APPROVAL: 1997
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
ANTIPSYCHOTIC DRUGS ARE ASSOCIATED WITH AN INCREASED RISK OF DEATH.
(5.1)
QUETIAPINE IS NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS. (5.1)
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS _SEE FULL PRESCRIBING
INFORMATION FOR COMPLETE_
_BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER AND OTHER PSYCHIATRIC
DISORDERS. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Hyperglycemia (5.4), 1/2011
Warnings and Precautions, Hyperlipidemia (5.5), 1/2011
Warnings and Precautions, Weight Gain (5.6), 1/2011
Warnings and Precautions, QT prolongation (5.12), 6/2011
Warnings and Precautions, Hypothyroidism (5.14), 1/2011
Warnings and Precautions, Withdrawal (5.23), 05/2010
INDICATIONS AND USAGE
Quetiapine fumarate tablet is an atypical antipsychotic indicated for
the: Treatment of schizophrenia (1.1)
Adults: Efficacy was established in three 6-week clinical trials in
patients with schizophrenia (14.1)
Acute treatment of manic episodes associated with bipolar I disorder,
both as monotherapy and as an adjunct to lithium or
divalproex (1.2)
Adults: Efficacy was established in two 12-week monotherapy trials and
in one 3-week adjunctive trial in patients with
manic episodes associated with bipolar I disorder (14.2)
Acute treatment of depressive episodes associated with bipolar
disorder (1.2)
Adults: Efficacy was established in two 8-week trials in patients with
bipolar I or II disorder (14.2)
Mainten