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:

Aphena Pharma Solutions - Tennessee, LLC

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 fumarate tablets in schizophrenia was established in three 6 week trials in adults. The effectiveness of quetiapine fumarate tablets 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 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

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. 25 mg Tablets : Peach, round, biconvex, film coated tablets. Engraved with 'APO' on one side and “QUE’ over ‘25’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-371-01) Bottles of 1000 (NDC 60429-371-10) 50 mg Tablets : White, round, biconvex, film coated tablets.  Engraved with 'APO' on one side and ‘QUE’ over ‘50’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-372-01) Bottles of 1000 (NDC 60429-372-10)   100 mg Tablets :  Yellow, round, biconvex film coated tablets. Engraved with 'APO' on one side and ‘QUE’ over ‘100’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-373-01) Bottles of 1000 (NDC 60429-373-10) 200 mg Tablets : White, round, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE’ over ‘200’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-374-01) Bottles of 1000 (NDC 60429-374-10)   300 mg Tablets : White, capsule-shaped, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE300’ on the other side. They are supplied as follows: Bottles of 60 (NDC 60429-375-60)   400 mg Tablets : Yellow, capsule-shaped, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE 400’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-376-01) Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
Quetiapine Fumarate
(kwe-TYE-a-peen FUE-ma-rate)
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 fumarate tablets 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
fumarate tablets can
increase the risk of death in elderly people who have memory lost
(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:
What else do I need to know about antidepressant medicines?
3.
High blood sugar (hyperglycemia): High blood sugar can happen if you
have diabetes already or if
you have never had diabetes.
High blood sugar can lead to:
a. Build up of acid in your blood due to ketones (ketoacidosis)
b. Coma
c. Death
Increases in blood sugar can happen in some people who take quetiapine
fumarate tablets.
Extremely high blood sugar can lead to coma or death. If you have
diabetes or risk factors for
diabetes (such as being overweight or a family history of diabetes)
your healthcare provider
should check your blood sugar before you start quetiapine fumarate
tablets and during therapy.
Call you doctor

Summary of Product characteristics

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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._
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), 5/2010
INDICATIONS AND USAGE
Quetiapine Fumarate Tablets is an atypical antipsychotic indicated for
the:
Treatment of schizophrenia (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)
Acute treatment of depressive episodes associated with bipolar
disorder (1.2)
Maintenance treatment of bipolar I disorder as an adjunct to lithium
or divalproex (1.2)
DOSAGE AND ADMINISTRATION
Quetiapine fumarate tablets can be taken with or without food. (3)
Indication
Dosing Instructions
Recommended
Dose /Dose
Range
Schizophre nia-Adults
(2.1) (3)
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, in
intervals
of not less than 2 days. (3)
150 to 750
mg/day (3)
Bipolar Mania- Adults
Monotherapy or as an
adjunct to lithium or
divalproex (2.2) (3)
Day 1: Twice daily dosing totaling 100 mg. (3)
Day 2: Twice daily dosin