QUETIAPINE FUMARATE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Lupin Pharmaceuticals, Inc.

INN (International Nazwa):

QUETIAPINE FUMARATE

Skład:

QUETIAPINE 25 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Quetiapine tablets USP are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets USP 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 tablets USP for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES (14.1 )]. Quetiapine tablets USP 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 tablets USP are 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

Podsumowanie produktu:

Quetiapine tablets USP , 25 mg (as quetiapine) are pink colored, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y15" on the other side, which are supplied as follows: NDC 68180-445-01    Bottle of 100s NDC 68180-445-03    Bottle of 1000s NDC 68180-445-13    Unit Dose Blisters of 10 x 10s Quetiapine tablets USP , 50 mg (as quetiapine) are white, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y16" on the other side, which are supplied as follows: NDC 68180-446-01    Bottle of 100s NDC 68180-446-03    Bottle of 1000s NDC 68180-446-13    Unit Dose Blisters of 10 x 10s Quetiapine tablets USP, 100 mg (as quetiapine) are yellow colored, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y17" on the other side, which are supplied as follows: NDC 68180-447-01    Bottle of 100s NDC 68180-447-03    Bottle of 1000s NDC 68180-447-13    Unit Dose Blisters of 10 x 10s Quetiapine tablets USP, 200 mg (as quetiapine) are white, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y18" on the other side, which are supplied as follows: NDC 68180-448-01    Bottle of 100s NDC 68180-448-02    Bottle of 500s NDC 68180-448-03    Bottle of 1000s NDC 68180-448-13    Unit Dose Blisters of 10 x 10s  Quetiapine tablets USP, 300 mg (as quetiapine) are white, capsule shape, biconvex, film-coated tablets, debossed "LU" on one side and "Y19" on the other side, which are supplied as follows: NDC 68180-449-07    Bottle of 60s NDC 68180-449-01    Bottle of 100s NDC 68180-449-02    Bottle of 500s NDC 68180-449-03    Bottle of 1000s NDC 68180-449-13    Unit Dose Blisters of 10 x 10s Quetiapine tablets USP, 400 mg (as quetiapine) are yellow colored, capsule shape, biconvex, film-coated tablets, debossed "LU" on one side and "Y20" on the other side, which are supplied as follows: NDC 68180-450-01    Bottle of 100s NDC 68180-450-02    Bottle of 500s NDC 68180-450-03    Bottle of 1000s NDC 68180-450-13    Unit Dose Blisters of 10 x 10s Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
Lupin Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Quetiapine (kwe-TYE-a-peen) Tablets USP
Read this Medication Guide before you start taking quetiapine 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
tablets?
Quetiapine tablets 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 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 the dose is changed.
•
Call the healthcare provider right away to report new or sudden
changes

Charakterystyka produktu

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
QUETIAPINE TABLETS.QUETIAPINE
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 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)
INDICATIONS AND USAGE
Quetiapine tablet USP is 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 tablets USP 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
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
_Geriatric Use_: Consider a lower starting dose (50 mg/day), slower
titration and careful monitoring during
the initial dosing period in the