QUETIAPINE FUMARATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Patient Information leaflet (PIL)

26-04-2021

Summary of Product characteristics (SPC)

26-04-2021

Active ingredient:

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

Available from:

TORRENT PHARMACEUTICALS LIMITED

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 w

Product summary:

Quetiapine tablets USP, 25 mg are brownish red colored, round, biconvex, film coated tablets with debossed "48" on one side and plain on other side. Bottles of 30 NDC 13668-148-30 Bottles of 100 NDC 13668-148-01 Bottles of 500 NDC 13668-148-05 Bottles of 1000 NDC 13668-148-10 Bottles of 6000 NDC 13668-148-42 100 Unit dose Tablets NDC 13668-148-74 Quetiapine tablets USP, 50 mg are white to off-white, round, biconvex, film coated tablets with debossed "49" on one side and plain on other side. Bottles of 30 NDC 13668-149-30 Bottles of 100 NDC 13668-149-01 Bottles of 500 NDC 13668-149-05 Bottles of 1000 NDC 13668-149-10 Bottles of 4500 NDC 13668-149-58 100 Unit dose Tablets NDC 13668-149-74 Quetiapine tablets USP, 100 mg are white to off-white, round, biconvex, film coated tablets with debossed "1150" on one side and plain on other side. Bottles of 30 NDC 13668-150-30 Bottles of 100 NDC 13668-150-01 Bottles of 500 NDC 13668-150-05 Bottles of 2000 NDC 13668-150-20 100 Unit dose Tablets NDC 13668-150-74 Quetiapine tablets USP, 200 mg are white to off-white, round, biconvex, film coated tablets with debossed "1151" on one side and plain on other side. Bottles of 30 NDC 13668-151-30 Bottles of 100 NDC 13668-151-01 Bottles of 500 NDC 13668-151-05 Bottles of 1500 NDC 13668-151-15 100 Unit dose Tablets NDC 13668-151-74 Quetiapine tablets USP, 300 mg are white to off-white, capsule shaped, biconvex, film coated tablets with debossed "1152" on one side and plain on other side. Bottles of 30 NDC 13668-152-30 Bottles of 60 NDC 13668-152-60 Bottles of 100 NDC 13668-152-01 Bottles of 500 NDC 13668-152-05 Bottles of 2500 NDC 13668-152-31 100 Unit dose Tablets NDC 13668-152-74 Quetiapine tablets USP, 400 mg are white to off-white, round, biconvex, film coated tablets with debossed "1153" on one side and plain on other side. Bottles of 30 NDC 13668-153-30 Bottles of 100 NDC 13668-153-01 Bottles of 500 NDC 13668-153-05 Bottles of 2000 NDC 13668-153-20 100 Unit dose Tablets NDC 13668-153-74 Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
TORRENT PHARMACEUTICALS LIMITED
----------
MEDGUIDE SECTION
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:
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 r

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Summary of Product characteristics

QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET
TORRENT 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 FUMARATE 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 ( 5.20) 9/2020
INDICATIONS AND USAGE
Quetiapine fumarate 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),

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