QUETIAPINE FUMARATE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Aphena Pharma Solutions - Tennessee, LLC

INN (Միջազգային անվանումը):

QUETIAPINE FUMARATE

Կազմը:

QUETIAPINE 25 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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-week monother

Ապրանքի ամփոփագիր:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Quetiapine Fumarate Tablets are supplied as white tablets. The 25 mg tablets are round and debossed with product identification "54 137" on one side and plain on the other side. The 50 mg tablets are oval and debossed with product identification "54" on one side and "377" on the other side. The 100 mg tablets are round and debossed with product identification "54 373" on one side and plain on the other side. The 200 mg tablets are round and debossed with product identification "54 527" on one side and plain on the other side. The 300 mg tablets are oval and debossed with product identification "54 531" on one side and plain on the other side. The 400 mg tablets are oval and debossed with product identification "54 735" on one side and plain on the other side. 0054-0220-25 25 mg, white tablet, bottle of 100 0054-0220-31 25 mg, white tablet, bottle of 1000 0054-0220-20 25 mg, white tablet, 10x10 unit dose 0054-0229-25 50 mg, white tablet, bottle of 100 0054-0229-31 50 mg, white tablet, bottle of 1000 0054-0229-20 50 mg, white tablet, 10x10 unit dose 0054-0221-25 100 mg, white tablet, bottle of 100 0054-0221-31 100 mg, white tablet, bottle of 1000 0054-0221-20 100 mg, white tablet, 10x10 unit dose 0054-0222-25 200 mg, white tablet, bottle of 100 0054-0222-29 200 mg, white tablet, bottle of 500 0054-0222-20 200 mg, white tablet, 10x10 unit dose 0054-0223-21 300 mg, white tablet, bottle of 60 0054-0223-29 300 mg, white tablet, bottle of 500 0054-0223-20 300 mg, white tablet, 10x10 unit dose 0054-0230-25 400 mg, white tablet, bottle of 100 0054-0230-20 400 mg, white tablet, 10x10 unit dose Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
Read this Medication Guide before you start taking quetiapine 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?
Quetiapine may cause serious side effects, including:
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 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:
•
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 the
dose is changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all fol

Ապրանքի հատկությունները

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
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, 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, 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:
•
•
•
DOSAGE AND ADMINISTRATION
•
Indication
Initial Dose
Recommended Dose
Maximum
Dose
Schizophrenia-Adults (2.1)
25 mg twice daily
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents
(13 to 17 years) (2.1)
25 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Adults Monotherapy or as an
adjunct to lithium or divalproex (2.1)
50 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10
to 17 years), Monotherapy (2.1)
25 mg twice daily
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults (2.1)
50 mg once daily at bedtime
300 mg/day
300 mg/day
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg (3)
CONTRAINDICATIONS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH. QUETIAPINE FUMARATE TABLETS ARE NOT APPROVED
FOR ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS (5.1)
INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS (5.2)
MONITOR FOR WORSENING AND EM