QUETIAPINE FUMARATE tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Aphena Pharma Solutions - Tennessee, LLC

INN (Међународно име):

QUETIAPINE FUMARATE

Састав:

QUETIAPINE 25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Quetiapine tablets, USP are 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 Clinical Studies (14.1) ]. Quetiapine tablets, USP are 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 tablets, USP are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials

Резиме производа:

Quetiapine tablets, USP Quetiapine tablets, USP 25 mg are peach, round, biconvex, film coated tablets. Engraved with 'APO' on one side and "QUE’ over ‘25’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-413-01) Bottles of 1000 (NDC 60429-413-10) Quetiapine tablets, USP 50 mg are white, round, biconvex, film coated tablets.  Engraved with 'APO' on one side and ‘QUE’ over ‘50’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-414-01) Bottles of 1000 (NDC 60429-414-10) Quetiapine tablets, USP 100 mg are  yellow, round, biconvex film coated tablets. Engraved with 'APO' on one side and ‘QUE’ over ‘100’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-415-01) Bottles of 1000 (NDC 60429-415-10) Quetiapine tablets, USP 200 mg are white, round, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE’ over ‘200’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-416-01) Bottles of 1000 (NDC 60429-416-10) Quetiapine tablets, USP 300 mg are white, capsule-shaped, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE300’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-417-01) Bottles of 1000 (NDC 60429-417-10)  Quetiapine tablets, USP 400 mg are yellow, capsule-shaped, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE 400’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-418-01) Bottles of 1000 (NDC 60429-418-10) Store at 20º to 25ºC (68º to 77ºF); excursions permitted from 15 to 30ºC (59 to 86ºF) [See USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
Quetiapine Tablets, USP
(kwe-TYE-a-peen FUE-ma-rate)
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:
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 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:
What else do I need to know about antidepressant medicines?
1.
all risks and benefits of treatment with antidepressant medicines
2.
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?
Call a healthcare provider right away if you or your family member has
any of the following
symptoms, especially if they are new, worse,

Карактеристике производа

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUETIAPINE TABLETS,
USP.
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
1.
SUICIDAL THOUGHTS AND BEHAVIORS
1.
2.
RECENT MAJOR CHANGES
Warnings and Precautions, Cerebrovascular Adverse Reactions, Including
Stroke, in Elderly Patients with Dementia-
Related Psychosis (5.3) 4/2013
INDICATIONS AND USAGE
Quetiapine tablets, USP are an atypical antipsychotic indicated for
the treatment of:
1.
2.
3.
DOSAGE AND ADMINISTRATION
Quetiapine tablets, USP can be taken with or without food (2.1)
INDIC ATIO N
INITIAL DOSE
RECOMMENDED DOSE
MAXIMUM DOSE
Schizophrenia-Adults (2.2)
25 mg twice daily
150 - 750 mg/day
750 mg/day
Schizophre nia-Adole sce nts
(13-17years) (2.2)
25 mg twicedaily
400 - 800 mg/day
800 mg/day
Bipolar Mania-
AdultsMonotherapy or as an
adjunct to lithium or
divalproex (2.2)
50 mg twice daily
400 - 800 mg/day
800 mg/day
Bipolar Mania-Children
andAdolescents (10 to
17years), Monotherapy(2.2)
25 mg twice daily
400 - 600 mg/day
600 mg/day
Bipolar Depression-Adults
(2.2)
50 mg once daily at bedtime
300 mg/day
300 mg/day
1.
2.
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to quetiapine fumarate tablets 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 IS NOT APPROVED FOR ELDERLY
PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS (