QUETIAPINE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

QUETIAPINE (UNII: BGL0JSY5SI) (QUETIAPINE - UNII:BGL0JSY5SI)

Available from:

Solco Healthcare U.S., LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with quetiapine tablets [see Clinical Studies (14.1)]. Quetiapine extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of quetiapine extended-release tablets in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar I disorder as wel

Product summary:

Quetiapine Extended-Release Tablets, USP: Store quetiapine extended-release tablets at 20o to 25o C (68o to 77o F); excursions permitted within 15o to 30o C (59o to 86o F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUETIAPINE- QUETIAPINE TABLET, EXTENDED RELEASE
Solco Healthcare U.S., LLC
----------
MEDICATION GUIDE
Quetiapine Extended-Release Tablets, USP
(kwe-TYE-a-peen)
Dispense with Medication Guide available at:
www.solcohealthcare.com/medguide/quetiapine-er-tablets.pdf
Read this Medication Guide before you start taking quetiapine
extended-release tablets and each time you get
a refill. There may be new information. This Medication Guide does not
take the place of talking to your
healthcare provider about your medical condition or treatment.
What is the most important information I should know about quetiapine
extended-release tablets?
Quetiapine extended-release tablets may cause serious side effects,
including:
1.
risk of death in the elderly with dementia: Medicines like quetiapine
extended-release tablets can
increase the risk of death in elderly people who have memory loss
(dementia). Quetiapine extended-
release 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 medicines 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

Summary of Product characteristics

QUETIAPINE- QUETIAPINE TABLET, EXTENDED RELEASE
SOLCO HEALTHCARE U.S., LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR QUETIAPINE
EXTENDED-RELEASE TABLETS.
QUETIAPINE EXTENDED-RELEASE 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
•
SUICIDAL THOUGHTS AND BEHAVIORS
•
•
INDICATIONS AND USAGE
Quetiapine extended-release tablets are an atypical antipsychotic
indicated for the treatment of:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
Schizophrenia -
Adults (2.2)
300
mg/day
400 to
800 mg/day
800 mg/day
Schizophrenia -
Adolescents (13
to 17 years)
(2.2)
50
mg/day
400 to
800 mg/day
800 mg/day
Bipolar I
Disorder manic
or mixed -
Acute
monotherapy or
adjunct to
lithium or
divalproex -
Adults (2.2)
300
mg/day
400 to
800 mg/day
800 mg/day
Bipolar I
Disorder, manic
Acute
monotherapy -
Children and
Adolescents (10
to 17 years)
(2.2)
50
mg/day
400 to
600 mg/day
600 mg/day
Bipolar
Disorder,
50
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS
ARE AT AN INCREASED RISK OF DEATH. QUETIAPINE EXTENDED-RELEASE TABLETS
ARE NOT
APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1)
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)
Schizophrenia (1.1)
Bipolar I disorder, manic, or mixed episodes (1.2)
Bipolar disorder, depressive episodes (1.2)
Major depressive disorder, adjunctive therapy with antidepressants
(1.3)
Swallow tablets whole and do not split, chew or crush (2.1)
Take without food or with a lig