QUETIAPINE FUMARATE- 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:

REMEDYREPACK INC.

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quetiapine tablets 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 (13-17 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 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 pati

Product summary:

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 30 (NDC 60505-3130-3) Bottles of 100 (NDC 60505-3130-1) Bottles of 500 (NDC 60505-3130-5) Bottles of 1,000 (NDC 60505-3130-8) Blisters of 30 (NDC 60505-3130-0) Blisters of 100 (NDC 60505-3131-0)  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 30 (NDC 60505-3132-3) Bottles of 100 (NDC 60505-3132-1) Bottles of 1,000 (NDC 60505-3132-8) Blisters of 100 (NDC 60505-3132-0)  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 30 (NDC 60505-3133-3) Bottles of 100 (NDC 60505-3133-1) Bottles of 500 (NDC 60505-3133-5) Bottles of 1,000 (NDC 60505-3133-8) Blisters of 30 (NDC 60505-3133-0) Blisters of 100 (NDC 60505-3134-0) 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 30 (NDC 60505-3135-3) Bottles of 100 (NDC 60505-3135-1) Bottles of 500 (NDC 60505-3135-5) Bottles of 1,000 (NDC 60505-3135-8) Blisters of 30 (NDC 60505-3135-0) Blisters of 100 (NDC 60505-3136-0)  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 30 (NDC 60505-3137-3) Bottles of 60 (NDC 60505-3137-6) Bottles of 100 (NDC 60505-3137-1) Bottles of 500 (NDC 60505-3137-5) Bottles of 1,000 (NDC 60505-3137-8) Blisters of 30 (NDC 60505-3137-0) Blisters of 100 (NDC 60505-3138-0)  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 30 (NDC 60505-3139-3) Bottles of 100 (NDC 60505-3139-1) Bottles of 1,000 (NDC 60505-3139-8) Blisters of 100 (NDC 60505-3139-0)  Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15°C to 30ºC (59°F to 86ºF) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
REMEDYREPACK INC.
----------
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:
•
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.
•
C

Summary of Product characteristics

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE 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 tablets are 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)
Indication
Initial Dose
Recommended
Dose
Maximum
Dose
Schizophrenia-Adults (2.2)
25 mg twice daily
150-750 mg/day
750 mg/day
Schizophrenia-Adolescents (13-17years) (2.2)
25 mg twice daily
400-800 mg/day
800 mg/day
Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or
divalproex (2.2)
50 mg twice daily
400-800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years),
Monotherapy (2.2)
25 mg twice daily
400-600 mg/day
600 mg/day
Bipolar Depression-Adults (2.2)
50 mg once daily at
be dtime
3