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:

Direct RX

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 1.1 Schizophrenia 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 Clinical Studies (14.1)] 1.2 Bipolar Disorder 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 Clinical Studies (14.2)] . Quetiapine fumarate tablet is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Effica

Product summary:

Quetiapine fumarate tablets are available as: 25 mg Tablets (NDC 16729-145) pink coloured, round, biconvex, film coated tablet, debossed '25' on one side and plain on other side, are supplied in bottles of 30 tablets (NDC 16729-145-10), 100 tablets (NDC 16729-145-01) and 1000 tablets (NDC 16729-145-17). 50 mg Tablets (NDC 16729-146) 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 16729-146-10), 100 tablets (NDC 16729-146-01) and 1000 tablets (NDC 16729-146-17). 100 mg Tablets (NDC 16729-147) yellow coloured, round, biconvex, film coated tablet, debossed ‘100’ on one side and ‘Q’ on other side, are supplied in bottles of 30 tablets (NDC 16729-147-10), 100 tablets (NDC 16729-147-01) and 1000 tablets (NDC 16729-147-17). 200 mg Tablets (NDC 16729-148) white to off white round, biconvex, film coated tablet, debossed ‘200’ on one side and plain on other side are supplied in bottles of 30 tablets (NDC 16729-148-10), 100 tablets (NDC 16729-148-01), and 1000 tablets (NDC 16729-148-17). 300 mg Tablets (NDC 16729-149) white to off white, capsule shaped, biconvex, film coated tablet, debossed '300' on one side and plain on other side, are supplied in bottles of 30 tablets (NDC 16729-149-10), 60 tablets (NDC 16729-149-12), 100 tablets (NDC 16729-149-01), and 1000 tablets (NDC 16729-149-17). 400 mg Tablets (NDC 16729-150) yellow coloured, capsule shaped, biconvex, film coated tablet, debossed '400' on one side and plain on other side, are supplied in bottles of 30 tablets (NDC 16729-150-10), 100 tablets (NDC 16729-150-01), and 500 tablets (NDC 16729-150-16). Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
Direct RX
----------
SPL MEDGUIDE
•
See FDA-approved patient labeling (Medication Guide)
Prescribers or other health professionals should inform patients,
their families, and their caregivers
about the benefits and risks associated with treatment with quetiapine
and should counsel them in
its appropriate use. A patient Medication Guide about
“Antidepressant Medicines, Depression and
other Serious Mental Illness, and Suicidal Thoughts or Actions” is
available for quetiapine. The
prescriber or health professional should instruct patients, their
families, and their caregivers to
read the Medication Guide and should assist them in understanding its
contents. Patients should be
given the opportunity to discuss the contents of the Medication Guide
and to obtain answers to any
questions they may have. The complete text of the Medication Guide is
reprinted at the end of this
document.
Patients should be advised of the following issues and asked to alert
their prescriber if these occur
while taking quetiapine.
Increased Mortality in Elderly Patients with Dementia-Related
Psychosis
Patients and caregivers should be advised that elderly patients with
dementia-related psychosis
treated with atypical antipsychotic drugs are at increased risk of
death compared with placebo.
Quetiapine is not approved for elderly patients with dementia-related
psychosis [ see Warnings
and Precautions (5.1)].
Suicidal Thoughts and Behaviors
Patients, their families, and their caregivers should be encouraged to
be alert to the emergence of
anxiety, agitation, panic attacks, insomnia, irritability, hostility,
aggressiveness, impulsivity,
akathisia (psychomotor restlessness), hypomania, mania, other unusual
changes in behavior,
worsening of depression, and suicidal ideation, especially early
during antidepressant treatment
and when the dose is adjusted up or down. Families and caregivers of
patients should be advised
to look for the emergence of such symptoms on a day-to-day basis,

Summary of Product characteristics

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
DIRECT RX
----------
QUETIAPINE FUMARATE
BOXED WARNING
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS
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 [ see Warnings and Precautions (5.1)] .
Quetiapine is not approved for
the treatment of patients with dementia-related psychosis [ see
Warnings and Precautions
(5.1)].
Suicidal Thoughts and Behaviors
Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents,
and young adults in short-term studies. These studies did not show an
increase in the risk of
suicidal thoughts and behavior with antidepressant use in patients
over age 24; there was a
reduction in risk with antidepressant use in patients aged 65 and
older [ see Warnings and
Precautions (5.2)] .
In patients of all ages who are started on antidepressant therapy,
monitor closely for
worsening, and for emergence of suicidal thoughts and behaviors.
Advise families and
caregivers of the need for close observation and communication with
the prescriber [ see
Warnings and Precautions (5.2)].
Quetiapine is not approved for use in pediatric patients under ten
years of age [ see Use in
Specific Populations (8.4)].
INDICATIONS AND USAGE
1.1 Schizophrenia
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 Clinical Studies (14.1)]
1.2 Bipolar Disorder
Quetiapine fumarate tablet is indicated for the acute treatment of
manic episodes associated with
bipolar I disorder, bo