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:

Aurobindo Pharma Limited

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 25 mg

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 25 mg are peach, round, biconvex, film-coated tablets debossed with ‘E 52’ on one side and plain on the other side.             Bottles of 100                                 NDC 65862-489-01             Bottles of 1,000                               NDC 65862-489-99             10 x 10 Unit-dose Tablets              NDC 65862-489-10 Quetiapine  Tablets, USP 50 mg are white, round, biconvex, film-coated tablets imprinted with ‘F 84’ on one side and plain on the other side.             Bottles of 100                                 NDC 65862-490-01             Bottles of 1,000                               NDC 65862-490-99             10 x 10 Unit-dose Tablets              NDC 65862-490-10 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 100                                 NDC 65862-491-01             Bottles of 1,000                               NDC 65862-491-99             10 x 10 Unit-dose Tablets              NDC 65862-491-10 Quetiapine  Tablets, USP 150 mg are light yellow, round, biconvex, film-coated tablets imprinted with ‘E 54’ on one side and plain on the other side.             Bottles of 100                                 NDC 65862-492-01             Bottles of 1,000                               NDC 65862-492-99             10 x 10 Unit-dose Tablets            NDC 65862-492-10      Quetiapine T ablets, USP 200 mg are white, round, biconvex, film-coated tablets imprinted with ‘E 55’ on one side and plain on the other side.             Bottles of 100                                 NDC 65862-493-01             Bottles of 1,000                               NDC 65862-493-99             10 x 10 Unit-dose Tablets              NDC 65862-493-10 Quetiapine  Tablets, USP 300 mg are white, capsule shaped, biconvex, film-coated tablets imprinted with ‘E 56’ on one side and plain on the other side.             Bottles of 60                                   NDC 65862-494-60             Bottles of 100                                 NDC 65862-494-01             Bottles of 1,000                               NDC 65862-494-99             10 x 10 Unit-dose Tablets              NDC 65862-494-10 Quetiapine  Tablets, USP 400 mg are yellow, capsule shaped, biconvex, film-coated tablets imprinted with ‘F 85’ on one side and plain on the other side.             Bottles of 100                                 NDC 65862-495-01             Bottles of 500                                 NDC 65862-495-05             10 x 10 Unit-dose Tablets              NDC 65862-495-10 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
Aurobindo Pharma Limited
----------
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:
•
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

Summary of Product characteristics

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
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)
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 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
_Geriatric Use:_ Consider a lower starting dose (50 mg/day), slower
titration and careful monitoring during
the initial dosing period in the e