QUETIAPINE FUMARATE- quetiapine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Contract Pharmacy Services-PA

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Quetiapine tablets USP, 100 mg (as quetiapine) are yellow colored, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y17" on the other side, which are supplied as follows: NDC 67046-636-07 blisterpacks of 7 NDC 67046-636-14 blisterpacks of 14 NDC 67046-636-15 blisterpacks of 15 NDC 67046-636-20 blisterpacks of 20 NDC 67046-636-21 blisterpacks of 21 NDC 67046-636-28 blisterpacks of 28 NDC 67046-636-30 blisterpacks of 30 NDC 67046-636-60 blisterpacks of 60 Quetiapine tablets USP, 200 mg (as quetiapine) are white, round, biconvex, film-coated tablets, debossed "LU" on one side and "Y18" on the other side, which are supplied as follows: NDC 67046-637-07 blisterpacks of 7 NDC 67046-637-14 blisterpacks of 14 NDC 67046-637-15 blisterpacks of 15 NDC 67046-637-20 blisterpacks of 20 NDC 67046-637-21 blisterpacks of 21 NDC 67046-637-28 blisterpacks of 28 NDC 67046-637-30 blisterpacks of 30 NDC 67046-637-60 blisterpacks of 60 Quetiapine tablets USP, 300 mg (as quetiapine) are white, capsule shape, biconvex, film-coated tablets, debossed "LU" on one side and "Y19" on the other side, which are supplied as follows: NDC 67046-638-07 blisterpacks of 7 NDC 67046-638-14 blisterpacks of 14 NDC 67046-638-15 blisterpacks of 15 NDC 67046-638-20 blisterpacks of 20 NDC 67046-638-21 blisterpacks of 21 NDC 67046-638-28 blisterpacks of 28 NDC 67046-638-30 blisterpacks of 30 NDC 67046-638-60 blisterpacks of 60 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUETIAPINE FUMARATE- QUETIAPINE TABLET
Contract Pharmacy Services-PA
----------
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:
•
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.
•
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 sudd

Summary of Product characteristics

QUETIAPINE FUMARATE- QUETIAPINE TABLET
CONTRACT PHARMACY SERVICES-PA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
636 QUETIAPINE 100 MG
637 QUETIAPINE 200 MG
638 QUETIAPINE 300 MG
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUETIAPINE TABLETS
USP.
QUETIAPINE TABLETS USP, 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
1. Warnings and Precautions, Falls (5.8) 02/2017
INDICATIONS AND USAGE
Quetiapine tablet USP 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 USP 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
Schizophre nia-
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