QUETIAPINE 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:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quetiapine tablet is 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 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) [

Product summary:

Quetiapine tablets, USP 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- QUETIAPINE TABLET, FILM COATED
REMEDYREPACK INC.
----------
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
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 tablet
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, behav

Summary of Product characteristics

QUETIAPINE- QUETIAPINE TABLET, FILM COATED
REMEDYREPACK INC.
----------
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
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)
Suicidal Thoughts and Behaviors
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)
RECENT MAJOR CHANGES
Warnings and Precautions, Leukopenia, Neutropenia and Agranulocytosis
( 5.10)
11/2018
Warnings and Precautions, Anticholinergic (antimuscarinic) Effects (
5.20)
11/2018
INDICATIONS AND USAGE
Quetiapine 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 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
50 mg twice daily
400 to 800
800 mg/day
divalproex ( 2.2)
50 mg twice daily
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-Adult