QUETIAPINE FUMARATE- quetiapine fumarate tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

REMEDYREPACK INC.

INN (International ime):

QUETIAPINE FUMARATE

Sastav:

QUETIAPINE 200 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 i

Proizvod sažetak:

25 mg tablets are peach, round, biconvex, film-coated tablets, debossed with ‘25’ on one side and plain on the other side and are supplied as: Bottles of 30’s with Child Resistant Cap ……………… NDC 47335-902-83 Bottles of 100’s with Child Resistant Cap …………….. NDC 47335-902-88 Bottles of 1000’s with Non Child Resistant Cap …..….. NDC 47335-902-18 Unit-dose blister pack of 100 (10 × 10) tablets ..………. NDC 47335-902-61   50 mg tablets are white, round, biconvex, film-coated tablets, debossed with ‘50’ on one side and plain on the other side and are supplied as:   Bottles of 30’s with Child Resistant Cap ……………… NDC 47335-903-83 Bottles of 100’s with Child Resistant Cap …………….. NDC 47335-903-88 Bottles of 1000’s with Non Child Resistant Cap …..….. NDC 47335-903-18 Unit-dose blister pack of 100 (10 × 10) tablets ..………. NDC 47335-903-61 100 mg tablets are yellow, round, biconvex, film-coated tablets, debossed with ‘904’ on one side and plain on the other side and are supplied as:   Bottles of 30’s with Child Resistant Cap ……………… NDC 47335-904-83 Bottles of 100’s with Child Resistant Cap …………….. NDC 47335-904-88 Bottles of 1000’s with Non Child Resistant Cap …..….. NDC 47335-904-18 Unit-dose blister pack of 100 (10 × 10) tablets ..………. NDC 47335-904-61   200 mg tablets are white, round, biconvex, film-coated tablets, debossed with ‘905’ on one side and plain on the other side and are supplied as:   Bottles of 30’s with Child Resistant Cap ……………… NDC 47335-905-83 Bottles of 100’s with Child Resistant Cap …………….. NDC 47335-905-88 Bottles of 1000’s with Non Child Resistant Cap …..….. NDC 47335-905-18 Unit-dose blister pack of 100 (10 × 10) tablets ..………. NDC 47335-905-61   300 mg tablets are white, capsule-shaped, biconvex, film-coated tablets, debossed with ‘906’ on one side and plain on the other side and are supplied as:   Bottles of 30’s with Child Resistant Cap ……………… NDC 47335-906-83 Bottles of 60’s with Child Resistant Cap ……………… NDC 47335-906-86 Bottles of 100’s with Child Resistant Cap …………….. NDC 47335-906-88 Bottles of 1000’s with Non Child Resistant Cap …..….. NDC 47335-906-18 Unit-dose blister pack of 100 (10 × 10) tablets ..………. NDC 47335-906-61   400 mg tablets are yellow, capsule-shaped, biconvex, film-coated tablets, debossed with ‘907’ on one side and plain on the other side and are supplied as:   Bottles of 30’s with Child Resistant Cap ……………… NDC 47335-907-83 Bottles of 100’s with Child Resistant Cap …………….. NDC 47335-907-88 Bottles of 1000’s with Non Child Resistant Cap …..….. NDC 47335-907-18 Unit-dose blister pack of 100 (10 × 10) tablets ..………. NDC 47335-907-61   Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
REMEDYREPACK 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 tablets 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 sudde

Svojstava lijeka

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
REMEDYREPACK 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)
RECENT MAJOR CHANGES
Warnings and Precautions, Leukopenia, Neutropenia and Agranulocytosis
(5.10) 11/2018
Warnings and Precautions, Anticholinergic (antimuscarinic) Effects
(5.20) 11/2018
INDICATIONS AND USAGE
Quetiapine tablets are 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 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 o