QUETIAPINE FUMARATE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

TYA Pharmaceuticals

INN (Mezinárodní Name):

QUETIAPINE FUMARATE

Složení:

QUETIAPINE 25 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see (14.1)] Clinical Studies 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, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [ . see (14.2)] Clinical Studies Quetiapine fumarate table

Přehled produktů:

NDC:64725-0145-1 in a CONTAINER of 30 TABLET, FILM COATEDS Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP].

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
TYA Pharmaceuticals
----------
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 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
fumarate tablets?
Quetiapine fumarate tablets may cause serious side effects, including:
Medicines like quetiapine fumarate tablets can increase the risk of
death in elderly people who have
memory loss (dementia). Quetiapine fumarate tablet is not for treating
psychosis in the elderly with
dementia. 1. risk of death 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.
•
These include people who have (or have a family history of)
depression, bipolar illness (also
called manic-depressive illness), or suicidal thoughts or actions.
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.
•
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 antidepressant
medicine is started or
when the dose is changed.
•
Call the he

Charakteristika produktu

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
TYA PHARMACEUTICALS
----------
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, 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 IS NOT APPROVED FOR ELDERLY
PATIENTS WITH DEMENTIA-RELATED
PSYC HO SIS5.1
Suicidal Thoughts and Behaviors
( ) INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDE PRE SSANTS5.2
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS
( ) 5.2
RECENT MAJOR CHANGES
Warnings and Precautions, Cerebrovascular Adverse Reactions, Including
Stroke, in Elderly Patients with Dementia-
Related Psychosis ( ) 4/2013 5.3
INDICATIONS AND USAGE
Quetiapine fumarate tablet is an atypical antipsychotic indicated for
the treatment of:
Schizophrenia ( ) 1.1
Bipolar I disorder manic episodes ( ) 1.2
Bipolar disorder, depressive episodes ( ) 1.2
DOSAGE AND ADMINISTRATION
Quetiapine fumarate tablets can be taken with or without food ( ). 2.1
INDIC ATIO N
INITIAL DOSE
RECO MMENDED
DO SE
MAXIMUM
DO SE
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/d