QUETIAPINE FUMARATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)] . Quetiapine tablets 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 are 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 bipo

Product summary:

Quetiapine Tablets, USP 100 mg are yellow, round, biconvex, film-coated tablets imprinted with ‘E 53’ on one side and plain on the other side.             Bottles of 30                              NDC 82804-020-30

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
Proficient Rx LP
----------
MEDICATION GUIDE
Quetiapine Tablets, USP
(kwe tye' a peen)
Read this Medication Guide before you start taking quetiapine 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
tablets?
Quetiapine tablets may cause serious side effects, including:
1.
risk of death in the elderly with dementia. Medicines like quetiapine
tablets can increase the risk of
death in elderly people who have memory loss (dementia). Quetiapine
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:
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
c

Summary of Product characteristics

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
PROFICIENT RX LP
----------
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 tablets are an atypical antipsychotic indicated for the
treatment of:
•
•
•
DOSAGE AND ADMINISTRATION
•
INDICATION
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: 100 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to quetiapine 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 (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 disorder, depressive epis