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:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 100 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 and one 6 week trial in adolescents (13 to 17 years). 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   )] . 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, and in one 3 week monotherapy trial in pediatric patients (10 to 17 years) [see Clinical Studies ( 14.2   )] . Quetiapine Fumarate Tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8 wee

Product summary:

Quetiapine Fumarate Tablets are available as follows: 25 mg – light orange, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “V7” on the other side, in bottles 1000. NDC 42291-695-10 50 mg – white to off-white, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8166” on the other side, in bottles of 1000. NDC 42291-696-10 100 mg – light orange, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8162” on the other side, in bottles of 90 and 1000. NDC 42291-697-90 NDC 42291-697-10 200 mg – white to off-white, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8163” on the other side, in bottles of 90 and 1000. NDC 42291-698-90 NDC 42291-698-10 300 mg – pale yellow, capsule-shaped, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8164” on the other side, in bottles of 60 and 1000. NDC 42291-699-60 NDC 42291-699-10 400 mg – white to off-white, capsule-shaped, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8165” on the other side, in bottles of 90 and 1000. NDC 42291-700-90 NDC 42291-700-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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 information does not take
the place of talking to your
healthcare provider about your medical condition or your 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. Medicines like
quetiapinefumarate tablets can increase
the risk of death in elderly people who havememory loss (dementia).
Quetiapine fumarate 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 medications 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
mood, behaviors,
thoughts, or feelings. This is very important when an antidepressant
medicine is started or
when t

Summary of Product characteristics

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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 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
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED
RISK OF DEATH. QUETIAPINE FUMARATE IS NOT APPROVED FOR ELDERLY
PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS (5.1)
SUICIDAL THOUGHTS AND BEHAVIORS
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)
RECENT MAJOR CHANGES
Warnings and Precautions, Cerebrovascular Adverse Reactions, Including
Stroke, in Elderly Patients with Dementia-
Related Psychosis (5.3) 4/2013
INDICATIONS AND USAGE
Quetiapine Fumarate Tablets are an atypical antipsychotic indicated
for the treatment of:
Schizophrenia (1.1)
Bipolar I disorder manic episodes (1.2)
Bipolar disorder, depressive episodes (1.2)
DOSAGE AND ADMINISTRATION
Quetiapine fumarate tablets can be taken with or without food (2.1)
Indication
Initial Dose
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.2)
25 mg twice daily
150 to 750 mg/day
750 mg/day
Schizophre nia-Adole sce nts
(13 to 17 years) (2.2)
25 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy
or as an adjunct to lithium or
divalproex (2.2)
50 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and
Adolescents (10 to 17
years), Monotherapy (2.2)
25 mg twice daily
400 to 600 mg/day
600 mg