SEROQUEL XR- quetiapine fumarate tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Avera McKennan Hospital

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SEROQUEL XR is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL XR 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 (13-17 years) treated with SEROQUEL [see Clinical Studies (14.1)]. SEROQUEL XR is 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 SEROQUEL XR 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 well as one 3-week monotherapy trial in children and adolescents (10 – 17 years) with manic episodes associated

Product summary:

300 mg Tablets (NDC 0310-0283) pale yellow, film coated, capsule-shaped, biconvex, intagliated tablet with “XR 300” on one side and plain on the other are supplied in bottles of 60 tablets and hospital unit dose packages of 100 tablets.NDC 69189-0484-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital Store SEROQUEL XR at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP].

Authorization status:

New Drug Application

Patient Information leaflet

SEROQUEL XR- QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
Avera McKennan Hospital
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MEDICATION GUIDE
SEROQUEL XR (SER-oh-kwell X-R)
(quetiapine fumarate)
Extended-Release Tablets
Read this Medication Guide before you start taking SEROQUEL XR 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 SEROQUEL
XR?
SEROQUEL XR may cause serious side effects, including:
1. risk of death in the elderly with dementia: Medicines like SEROQUEL
XR can increase the risk
of death in elderly people who have memory loss (dementia). SEROQUEL
XR 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:
o all risks and benefits of treatment with antidepressant medicines
o 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?
o 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.
o Call the healthcare provider right away to report new or sudden
chan

Summary of Product characteristics

SEROQUEL XR- QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEROQUEL XR SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR SEROQUEL XR.
SEROQUEL XR (QUETIAPINE FUMARATE) 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
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Falls (5.8)
02/2017
INDICATIONS AND USAGE
SEROQUEL XR is an atypical antipsychotic indicated for the treatment
of:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
INDIC ATIO N
I NITIAL
DO SE
RECO MMENDED
DO SE
MAXIMUM DOSE
Schizophrenia- Adults (2.2)
300 mg/day 400-800 mg/day
800 mg/day
Schizophrenia-Adolescents (13 to 17 years) (2.2)
50 mg/day
400-800 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 400-800 mg/day
800 mg/day
Bipolar I Disorder, manic Acute monotherapy -Children and
Adolescents (10 to 17 years) (2.2)
50 mg/day
400-600 mg/day
600 mg/day
Bipolar Disorder, Depressive Episodes-Adults (2.2)
50 mg/day
300 mg/day
300 mg/day
Major Depressive Disorder, Adjunctive Therapy with Antidepressants-
Adults (2.2)
50 mg/day
150-300 mg/day
300 mg/day
DOSAGE FORMS AND STRENGTHS
Extended-Release Tablets: 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg
(3)
CONTRAINDICATIONS
Known hypersensitivity to SEROQUEL XR or any components in the
formulation (4)
WARNINGS AND PRECAUTIONS
•
®
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH. SEROQUEL XR IS NOT APPROVED FOR ELDERLY
PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS (5.1)
INCREASED RISK OF SUICIDAL THOUGHT