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:

Physicians Total Care, Inc.

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quetiapine fumarate tablets are indicated for the treatment of schizophrenia. The efficacyof quetiapine in schizophrenia was established in three 6 week trials in adults. The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see Clinical Studies (14.1) ].    Pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. Quetiapine fumarate 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, [see Clinical Studies (14.2) ]. Quetiapine f

Product summary:

Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied in Quetiapine fumarate tablets 50 mg are white colored, round, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘2’ on other side and they are supplied in Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied in Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘5’ on other side and they are supplied in Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with 'R' on one side and '6' on other side and they are supplied in Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
Physicians Total Care, Inc.
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MEDICATION GUIDE
QUETIAPINE FUMARATE TABLETS
Read this Medication Guide before you start taking quetiapine fumarate
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
fumarate tablets?
Quetiapine may cause serious side effects, including
1. Risk of death in the elderly with dementia
2. Risk of suicidal thoughts or actions
3. High blood sugar (hyperglycemia)
4. High fat levels in your blood (increased cholesterol and
triglycerides)
5. Weight gain
These serious side effects are described below:
1.Risk of death in the elderly with dementia: Medicines like
quetiapine can increase the risk of death in
elderly people who have memory loss (dementia). Quetiapine fumarate
tablets are not approved 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
mem

Summary of Product characteristics

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE FUMARATE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUETIAPINE FUMARATE
TABLETS.
QUETIAPINE FUMARATE TABLETS
INITIAL U.S. APPROVAL: 1997
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA RELATED
PSYCHOSIS
_See Full Prescribing Information for complete boxed warning._
Antipsychotic drugs are associated with an increased risk of death
(5.1)
Quetiapine is not approved for elderly patients with Dementia-Related
Psychosis (5.1)
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
_See Full Prescribing Information for complete boxed warning._
Increased risk of suicidal thinking and behavior in children,
adolescents and young adults taking antidepressants
for major depressive disorder and other psychiatric disorders (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Hyperglycemia (5.4), 1/2011
Warnings and Precautions, Hyperlipidemia (5.5), 1/2011
Warnings and Precautions, Weight Gain (5.6), 1/2011
Warnings and Precautions, QT prolongation (5.12), 6/2011
Warnings and Precautions, Hypothyroidism (5.14), 1/2011
Warnings and Precautions, Withdrawal (5.23), 05/2010
INDICATIONS AND USAGE
Quetiapine is an atypical antipsychotic indicated for the:
Treatment of schizophrenia (1.1) (1)
Adults: Efficacy was established in three 6-week clinical trials in
patients with schizophrenia (14.1)
Acute treatment of manic episodes associated with bipolar I disorder,
both as monotherapy and as an adjunct to lithium or
divalproex (1.2) (1)
Adults: Efficacy was established in two 12-week monotherapy trials and
in one 3-week adjunctive trial in patients with
manic episodes associated with bipolar I disorder (14.2)
Acute treatment of depressive episodes associated with bipolar
disorder (1.2) (1)
Adults: Efficacy was established in two 8-week trials in patients with
bipolar I or II disorder (14.2)
Ma