QUETIAPINE FUMARATE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

RedPharm Drug, Inc.

INN (Mezinárodní Name):

QUETIAPINE FUMARATE

Složení:

QUETIAPINE 25 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

1.1 Schizophrenia 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)]. 1.2 Bipolar Disorder Quetiapineis 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

Přehled produktů:

Quetiapine tablets, USP 25 mg Peach coloured, film coated, round shape, biconvex tablets, debossed with "262” on one side and plain on other side. Bottles of 100 tablets NDC 67877-242-01 Bottles of 1000 tablets NDC 67877-242-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-242-38 Blister pack of 10 tablets NDC 67877-242-33 Quetiapine tablets, USP 50 mg White coloured, film coated, round shape, biconvex tablets, debossed with"337" on one side and plain on other side. Bottles of 100 tablets NDC 67877-249-01 Bottles of 1000 tablets NDC 67877-249-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-249-38 Carton pack of 10 tablets (1 x 10’s blister pack) NDC 67877-249-33 Quetiapine tablets, USP 100 mg Yellow coloured, film coated, round shape, biconvex tablets, debossed with "261" on one side and plain on other side. Bottles of 100 tablets NDC 67877-250-01 Bottles of 1000 tablets NDC 67877-250-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-250-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-250-33 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. Bottles of 100 tablets NDC 67877-245- 01 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-245-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-245-33 Quetiapine tablets, USP 200 mg White coloured, film coated, round shape, biconvex tablets, debossed with "260" on one side and plain on other side. Bottles of 100 tablets NDC 67877-246- 01 Bottles of 1000 tablets NDC 67877-246-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-246-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-246-33 Quetiapine tablets, USP 300 mg White coloured, film coated, capsule shaped, biconvex tablets, debossed with "259" on one side and plain on other side. Bottles of 60 tablets NDC 67877-247- 60 Bottles of 1000 tablets NDC 67877-247-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-247-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-247-33 Quetiapine tablets, USP 400 mg Yellow coloured, film coated, capsule shaped, biconvex tablets, debossed with "336" on one side and plain on other side. Bottles of 100 tablets NDC 67877-248- 01 Bottles of 1000 tablets NDC 67877-248-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-248-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-248-33 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP].

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

RedPharm Drug, Inc.
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17 PATIENT COUNSELING
INFORMATION
See FDA-approved patient labeling (Medication Guide)
Prescribers or other health professionals should inform patients,
their families, and their caregivers about the
benefits and risks associated with treatment with quetiapine and
should counsel them in its appropriate use. A
patient Medication Guide about “Antidepressant Medicines, Depression
and other Serious Mental Illness,
and Suicidal Thoughts or Actions” is available for quetiapine. The
prescriber or health professional should
instruct patients, their families, and their caregivers to read the
Medication Guide and should assist them in
understanding its contents. Patients should be given the opportunity
to discuss the contents of the Medication
Guide and to obtain answers to any questions they may have. The
complete text of the Medication Guide is
reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert
their prescriber if these occur while
taking quetiapine.
Increased Mortality in Elderly Patients with Dementia-Related
Psychosis Patients and caregivers should be
advised that elderly patients with dementia-related psychosis treated
with atypical antipsychotic drugs are at
increased risk of death compared with placebo. Quetiapine is not
approved for elderly patients with
dementia-related psychosis [see WARNINGS AND PRECAUTIONS (5.1)].
Suicidal Thoughts and Behaviors
Patients, their families, and their caregivers should be encouraged to
be alert to the emergence of anxiety,
agitation, panic attacks, insomnia, irritability, hostility,
aggressiveness, impulsivity, akathisia (psychomotor
restlessness), hypomania, mania, other unusual changes in behavior,
worsening of depression, and suicidal
ideation, especially early during antidepressant treatment and when
the dose is adjusted up or down. Families
and caregivers of patients should be advised to look for the emergence
of such symptoms on a day-to-day
basis, since changes may be abrupt. Such s

Charakteristika produktu

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
REDPHARM DRUG, INC.
----------
BOXED WARNING
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS
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 [see WARNINGS AND PRECAUTIONS
(5.1)].
Quetiapine is not approved for the treatment of patients with
dementia-related
psychosis [see WARNINGS AND PRECAUTIONS (5.1)].
Suicidal Thoughts and Behaviors
Antidepressants increased the risk of suicidal thoughts and behavior
in children,
adolescents, and young adults in short-term studies. These studies did
not show
an increase in the risk of suicidal thoughts and behavior with
antidepressant use in
patients over age 24; there was a reduction in risk with
antidepressant use in
patients aged 65 and older [see WARNINGS AND PRECAUTIONS (5.2)].
In patients of all ages who are started on antidepressant therapy,
monitor closely
for worsening, and for emergence of suicidal thoughts and behaviors.
Advise
families and caregivers of the need for close observation and
communication with
the prescriber [see WARNINGS AND PRECAUTIONS (5.2)].
Quetiapine is not approved for use in pediatric patients under ten
years of age [see
USE IN SPECIFIC POPULATIONS (8.4)].
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: INCREASEDMORTALITYINELDERLYPATIENTS WITHDEMENTIA-
RELATEDPSYCHOSIS;ANDSUICIDAL THOUGHTSANDBEHAVIORS
SEEFULLPRESCRIBING INFORMATIONFORCOMPLETEBOXEDWARNING.
IncreasedMortalityin ElderlyPatientswithDementia-Related Psychosis
· Elderly patients withdementi