QUETIAPINE FUMARATE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

AvPAK

INN (nume internaţional):

QUETIAPINE FUMARATE

Compoziție:

QUETIAPINE 25 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)]. Quetiapine 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 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 bipolar I and bipolar II disorder [se

Rezumat produs:

Quetiapine tablets, USP 25 mg Peach coloured, film coated, round shape, biconvex tablets, debossed with "262 ” on one side and plain on other side. NDC 50268-630-15 (10 tablets per card, 5 cards per carton) Quetiapine tablets, USP 50 mg White coloured, film coated, round shape, biconvex tablets, debossed with"337" on one side and plain on other side. NDC 50268-631-15 (10 tablets per card, 5 cards per carton) Quetiapine tablets, USP 100 mg Yellow coloured, film coated, round shape, biconvex tablets, debossed with "261" on one side and plain on other side. NDC 50268-632-15 (10 tablets per card, 5 cards per carton) Quetiapine tablets, USP 150 mg Off white to light yellow coloured, film coated, round shape, biconvex tablets, debossed with "353" on one side and plain on other side. Quetiapine tablets, USP 200 mg White coloured, film coated, round shape, biconvex tablets, debossed with "260" on one side and plain on other side. NDC 50268-633-15 (10 tablets per card, 5 cards per carton) Quetiapine tablets, USP 300 mg White coloured, film coated, capsule shaped, biconvex tablets, debossed with "259" on one side and plain on other side. NDC 50268-634-15 (10 tablets per card, 5 cards per carton) Quetiapine tablets, USP 400 mg Yellow coloured, film coated, capsule shaped, biconvex tablets, debossed with "336" on one side and plain on other side. NDC 50268-635-15 (10 tablets per card, 5 cards per carton) Dispensed in Unit Dose Package. For Institutional Use Only. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP].

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
AvPAK
----------
SPL MEDGUIDE SECTION
Medication Guide
Quetiapine Tablets
(kwe-TYE-a-peen)
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?
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
feeli

Caracteristicilor produsului

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
AVPAK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
QUETIAPINE TABLETS, USP
RX ONLY
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 TABLETS 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 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),