QUETIAPINE FUMARATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug, Inc.

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Schizophrenia Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 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 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 is 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 bipolar I and b

Product summary:

Quetiapine tablets, USP 25 mg Peach coloured, film coated, round shape, biconvex tablets, debossed with "262” on one side and plain on other side. Bottles of 100 tablets NDC 67877-242-01 Bottles of 1000 tablets NDC 67877-242-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-242-38 Blister pack of 10 tablets NDC 67877-242-33 Quetiapine tablets, USP 50 mg White coloured, film coated, round shape, biconvex tablets, debossed with"337" on one side and plain on other side. Bottles of 100 tablets NDC 67877-249-01 Bottles of 1000 tablets NDC 67877-249-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-249-38 Carton pack of 10 tablets (1 x 10’s blister pack) NDC 67877-249-33 Quetiapine tablets, USP 100 mg Yellow coloured, film coated, round shape, biconvex tablets, debossed with "261" on one side and plain on other side. Bottles of 100 tablets NDC 67877-250-01 Bottles of 1000 tablets NDC 67877-250-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-250-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-250-33 Quetiapine tablets, USP 150 mg Off white to light yellow coloured, film coated, round shape, biconvex tablets, debossed with "353" on one side and plain on other side. Bottles of 100 tablets NDC 67877-245- 01 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-245-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-245-33 Quetiapine tablets, USP 200 mg White coloured, film coated, round shape, biconvex tablets, debossed with "260" on one side and plain on other side. Bottles of 100 tablets NDC 67877-246- 01 Bottles of 1000 tablets NDC 67877-246-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-246-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-246-33 Quetiapine tablets, USP 300 mg White coloured, film coated, capsule shaped, biconvex tablets, debossed with "259" on one side and plain on other side. Bottles of 60 tablets NDC 67877-247- 60 Bottles of 1000 tablets NDC 67877-247-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-247-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-247-33 Quetiapine tablets, USP 400 mg Yellow coloured, film coated, capsule shaped, biconvex tablets, debossed with "336" on one side and plain on other side. Bottles of 100 tablets NDC 67877-248- 01 Bottles of 1000 tablets NDC 67877-248-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-248-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-248-33 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUETIAPINE FUMARATE- quetiapine fumarate tablet
RedPharm Drug, Inc.
----------
SPL MEDGUIDE SECTION
Medication Guide
Quetiapine Tablets
(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?
Quetiapine may cause serious side effects, including:
1. risk of death in the elderly with dementia. Medicines like
quetiapine can increase the risk of death in
elderly people who have memory loss (dementia). Quetiapine is 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:
· 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 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 healthcare provider right away to report new or sudden
changes in mood, behavior, thou

Summary of Product characteristics

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
REDPHARM DRUG, INC.
----------
QUETIAPINE
BOXED WARNING
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS
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)].
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.
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Increased M