QUETIAPINE FUMARATE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Alembic Pharmaceuticals Limited

INN (Algemene Internationale Benaming):

QUETIAPINE FUMARATE

Samenstelling:

QUETIAPINE 25 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Quetiapine fumarate is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate  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  for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1) ]. Quetiapine fumarate  is 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 is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipo

Product samenvatting:

Quetiapine Fumarate Tablets are supplied as below: 25 mg: White to off white, round, biconvex, film coated tablets debossed with ‘224’ on one side and ‘L’ on the other side. NDC 46708-134-30    bottle of 30 tablets NDC 46708-134-31    bottle of 100 tablets NDC 46708-134-91    bottle of 1000 tablets NDC 46708-134-10    100 (10 x 10) Tablets Unit dose package    50 mg: White to off white, round, biconvex, film coated tablets debossed with ‘225’ on one side and ‘L’ on the other side. NDC 46708-135-30    bottle of 30 tablets NDC 46708-135-31    bottle of 100 tablets NDC 46708-135-91    bottle of 1000 tablets NDC 46708-135-10    100 (10 x 10) Tablets Unit dose package    100 mg: White to off white, round, biconvex, film coated tablets debossed with ‘226’ on one side and ‘L’ on the other side. NDC 46708-136-30    bottle of 30 tablets NDC 46708-136-31    bottle of 100 tablets NDC 46708-136-91    bottle of 1000 tablets NDC 46708-136-10    100 (10 x 10) Tablets Unit dose package 200 mg: White to off white, round, biconvex, film coated tablets, debossed with ‘L227’ on one side and plain on the other side. NDC 46708-137-30    bottle of 30 tablets NDC 46708-137-31    bottle of 100 tablets NDC 46708-137-91    bottle of 1000 tablets NDC 46708-137-10    100 (10 x 10) Tablets Unit dose package    300 mg: White to off white, capsule shaped, biconvex, film coated tablets, debossed with ‘L228’ on one side and plain on the other side. NDC 46708-138-30    bottle of 30 tablets NDC 46708-138-60    bottle of 60 tablets NDC 46708-138-91    bottle of 1000 tablets NDC 46708-138-10    100 (10 x 10) Tablets Unit dose package    400 mg: White to off white, capsule shaped, biconvex, film coated tablets, debossed with ‘L229’ on one side and plain on the other side. NDC 46708-139-30    bottle of 30 tablets NDC 46708-139-31    bottle of 100 tablets NDC 46708-139-71    bottle of 500 tablets NDC 46708-139-10    100 (10 x 10) Tablets Unit dose package    Store at 25ºC (77ºF); excursions permitted to 15° to 30ºC (59° to 86ºF) [see USP].

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
Alembic Pharmaceuticals Limited
----------
MEDICATION GUIDE
Quetiapine Fumarate
(kwe-TYE-a-peen FUE-ma-rate) Tablets
Read this Medication Guide before you start taking quetiapine fumarate
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?
quetiapine fumarate may cause serious side effects, including:
1. risk of death in the elderly with dementia. Medicines like
quetiapine fumarate can increase the risk of
death in elderly people who have memory loss (dementia). Quetiapine
fumarate 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:
o all risks and benefits of treatment with antidepressant medicines.
o 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 suicidalthoughts 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 afamily member?
o 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.
o Call the healthcare provider right awa

Productkenmerken

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS LIMITED
----------
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, Falls (5.8) 02/2017
INDICATIONS AND USAGE
Quetiapine fumarate is an atypical antipsychotic indicated for the
treatment of: (1)
· Schizophrenia (1.1) (1)
· Bipolar I disorder manic episodes (1.2) (1)
· Bipolar disorder, depressive episodes (1.2) (1)
DOSAGE AND ADMINISTRATION
• Quetiapine fumarate can be taken with or without food (2.1). (2)
Indication
Initial Dose
Recommended
Dose
Maximum
Dose
Schizophrenia-Adults (2.2)
25 mg twice daily
150 to 750
mg/day
750
mg/day
Schizophrenia-Adolescents (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/day
Bipolar Depression-Adults (2.2)
50 mg once daily at
bedtime
300 mg/day
300
mg/day
(