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:

Cardinal Health

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quetiapine fumarate tablets are indicated for the treatment of schizophrenia. The efficacy of 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 fum

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 : Available overbagged with 10 tablets per bag, NDC 55154-3379-0 Quetiapine fumarate tablets are available as 50 mg, white colored, round, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘2’ on other side and they are supplied : Overbagged with 10 tablets per bag, NDC 55154-7648-0 Quetiapine fumarate tablets are available as 100 mg, yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied : Available overbagged with 10 tablets per bag, NDC 55154-3380-0 Quetiapine fumarate tablets are available as 200 mg, white, round, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘5’ on other side and they are supplied : Available overbagged with 10 tablets per bag, NDC 55154-3381-0 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
Cardinal Health
----------
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 member?
•
Pay

Summary of Product characteristics

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
CARDINAL HEALTH
----------
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._
•
• WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
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)
•
Acute treatment of manic episodes associated with bipolar I disorder,
both as monotherapy and as an adjunct to lithium or
divalproex (1.2) (1)
•
Acute treatment of depressive episodes associated with bipolar
disorder (1.2) (1)
•
Maintenance treatment of bipolar disorder as an adjunct to lithium or
divalproex (1.2) (1)
•
DOSAGE AND ADMINISTRATION
Quetiapine fumarate tablets can be taken with or without food. (2)
INDICATION (2)
DOSING INSTRUCTIONS* (2)
RECOMMENDED DOSE / DOSE RANGE
(2)
Schizophrenia-Adults (2.1) (2)
Day 1: 25 mg twice daily. Increase in
increments of 25 mg to 50 mg divided
two or three times on Days 2 and 3 to
range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day,
150 to 750 mg/day (2)
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)
Increased risk of su