QUETIAPINE tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

AvKARE

DCI (Dénomination commune internationale):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 25 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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-wee

Descriptif du produit:

Quetiapine Tablets, USP are available as follows: 25 mg – light orange, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “V7” on the other side, in bottles of 90 (NDC 42291-695-90) and bottles of 1000 (NDC 42291-695-10) 50 mg – white to off-white, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8166” on the other side, in bottles of 90 (NDC 42291-696-90) and bottles of 1000 (NDC 42291-696-10) 100 mg – light orange, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8162” on the other side, in bottles of 90 (NDC 42291-697-90) and bottles of 1000 (NDC 42291-697-10) 200 mg – white to off-white, round, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8163” on the other side, in bottles of 90 (NDC 42291-698-90) and bottles of 500 (NDC 42291-698-50) 300 mg – pale yellow, capsule-shaped, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8164” on the other side, in bottles of 90 (NDC 42291-699-90) and bottles of 500 (NDC 42291-699-50) 400 mg – white to off-white, capsule-shaped, biconvex, film-coated, unscored tablets, debossed with “93” on one side and “8165” on the other side, in bottles of 90 (42291-700-90) and bottles of 500 (NDC 42291-700-50) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

QUETIAPINE- QUETIAPINE TABLET, FILM COATED
AvKARE
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MEDICATION GUIDE
Quetiapine ( kwe tye’ a peen)
Tablets
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 sudden
changes in mood,
behavior

Résumé des caractéristiques du produit

QUETIAPINE- QUETIAPINE TABLET, FILM COATED
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
QUETIAPINE TABLET
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.
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 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 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), slower
titration and careful monitoring during
the initial dosing period in the elderly ( 2.3, 8.5)
_Hepatic Impairment:_ Lower sta