QUETIAPINE FUMARATE tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Dr.Reddy's Laboratories Limited

INN (International Nazwa):

QUETIAPINE FUMARATE

Skład:

QUETIAPINE 50 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-249-30 Bottles of 60                                                               NDC 55111-249-60 Bottles of 100                                                              NDC 55111-249-01 Bottles of 500                                                               NDC 55111-249-05 Unit dose package of 100 (10 x 10)                           NDC 55111-249-78  Quetiapine fumarate tablets 50 mg are white colored, round, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘2’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-169-30 Bottles of 60                                                               NDC 55111-169-60 Bottles of 100                                                              NDC 55111-169-01 Bottles of 500                                                              NDC 55111-169-05 Unit dose package of 100 (10 x 10)                           NDC 55111-169-78  Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-186-30 Bottles of 60                                                               NDC 55111-186-60 Bottles of 100                                                              NDC 55111-186-01 Bottles of 500                                                              NDC 55111-186-05 Unit dose package of 100 (10 x 10)                           NDC 55111-186-78 Quetiapine fumarate tablets 150 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘188’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-188-30 Bottles of 60                                                               NDC 55111-188-60 Bottles of 100                                                             NDC 55111-188-01 Bottles of 500                                                             NDC 55111-188-05 Unit dose package of 100 (10 x 10)                           NDC 55111-188-78 Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘5’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-189-30 Bottles of 60                                                               NDC 55111-189-60 Bottles of 100                                                             NDC 55111-189-01 Bottles of 500                                                             NDC 55111-189-05 Unit dose package of 100 (10 x 10)                           NDC 55111-189-78 Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘6’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-190-30 Bottles of 60                                                               NDC 55111-190-60 Bottles of 100                                                             NDC 55111-190-01 Bottles of 500                                                             NDC 55111-190-05 Unit dose package of 100 (10 x 10)                           NDC 55111-190-78 Quetiapine fumarate tablets 400 mg are yellow colored, capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘7’ on other side and they are supplied in bottles of 30’s, 60’s,100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-606-30 Bottles of 60                                                               NDC 55111-606-60 Bottles of 100                                                              NDC 55111-606-01 Bottles of 500                                                              NDC 55111-606-05 Unit dose package of 100 (10 x 10)                           NDC 55111-606-78 Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
Dr.Reddy's Laboratories Limited
----------
Medication Guide
Quetiapine Fumarate Tablets
(kwe tye'a peen)
Read this Medication Guide before you start taking quetiapine fumarate
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
fumarate tablets?
Quetiapine fumarate tablets may cause serious side effects, including:
1. risk of death in the elderly with dementia. Medicines like
quetiapine fumarate tablets can increase the
risk of death in elderly people who have memory loss (dementia).
Quetiapine fumarate 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.

Charakterystyka produktu

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED
DR.REDDY'S LABORATORIES 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
DEMENTIAL-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 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 can be taken with or without food (2.1)
INDIC ATIO N
INITIAL DOSE
RECO MMENDED
DO SE
MAXIMUM
DO SE
SCHIZOPHRENIA-ADULTS (2.2)
25 mg twice
daily
150 to 750
mg/day
750
MG /DAY
SCHIZOPHRENIA-ADOLESCENTS
(13 TO 17YEARS) (2.2)
25 mg twice
daily
400 to 800
mg/day
8 0 0
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
8 0 0
MG /DAY
BIPOLAR MANIA-CHILDREN AND ADOLESCENTS (10 TO
17 YEARS), MONOTHERAPY(2.2)
25 mg twice
daily
400 to 600
mg/day
6 0 0
MG /DAY
BIPOL