QUETIAPINE FUMARATE tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Macleods Pharmaceuticals Limited

INN (Միջազգային անվանումը):

QUETIAPINE FUMARATE

Կազմը:

QUETIAPINE 25 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)]. Quetiapine 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 tablets 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 patients with bipolar I a

Ապրանքի ամփոփագիր:

Quetiapine tablets, USP are available as follows: 25 mg: Peach colored, round, film coated tablets debossed with "F 71" on one side and plain on the other side. Bottles of 100's NDC 33342-099-11 Bottles of 1000's NDC 33342-099-44 Unit dose blister pack of 100's NDC 33342-099-12 50 mg: White colored, round, film coated tablets, debossed with "F 72" on one side and plain on the other side. Bottles of 100's NDC 33342-100-11 Bottles of 1000's NDC 33342-100-44 Unit dose blister pack of 100's NDC 33342-100-12 100 mg: Yellow colored, round, film coated tablets debossed with "F 73" on one side and plain on the other side. Bottles of 100's NDC 33342-101-11 Bottles of 1000's NDC 33342-101-44 Unit dose blister pack of 100's NDC 33342-101-12 200 mg: White colored, round, film coated tablets debossed with "F 75" on one side and plain on the other side. Bottles of 100's NDC 33342-103-11 Bottles of 500's NDC 33342-103-15 Bottles of 1000's NDC 33342-103-44 Unit dose blister pack of 100's NDC 33342-103-12 300 mg: White colored, capsule shaped, film coated tablets debossed with "F 76" on one side and plain on the other side. Bottles of 60's NDC 33342-104-09 Bottles of 500's NDC 33342-104-15 Bottles of 1000's NDC 33342-104-44 Unit dose blister pack of 90's NDC 33342-104-39 400 mg: Yellow colored, capsule shaped, film coated tablets debossed with "F 77" on one side and plain on the other side. Bottles of 100's NDC 33342-105-11 Bottles of 500's NDC 33342-105-15 Unit dose blister pack of 90's NDC 33342-105-39   Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
Macleods Pharmaceuticals Limited
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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
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

Ապրանքի հատկությունները

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET, FILM COATED
MACLEODS PHARMACEUTICALS LIMITED
----------
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 tablets are 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 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 (13-17 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 i