QUETIAPINE tablet, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Macleods Pharmaceuticals Limited

SNN (starptautisko nepatentēto nosaukumu):

QUETIAPINE FUMARATE

Kompozīcija:

QUETIAPINE 150 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with quetiapine [see Clinical Studies (14.1) ]. Quetiapine  extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of quetiapine  extended-release tablets in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar I disorder as well as

Produktu pārskats:

Quetiapine extended-release tablets,USP 150 mg 150 mg tablets are white to off white colored, capsule shaped, film coated tablets debossed with 'C 22' on one side and plain on the other side and are available as follows: Bottles of 60 tablets                           NDC 33342-134-09 Bottles of 500 tablets                         NDC 33342-134-15 Quetiapine  extended-release tablets,USP 200 mg 200 mg tablets are yellow colored, capsule shaped, film coated tablets debossed with 'C 23' on one side and plain on the other side and are available as follows: Bottles of 60 tablets                           NDC 33342-135-09 Bottles of 500 tablets                         NDC 33342-135-15 Quetiapine  extended-release tablets,USP 300 mg 300 mg tablets are pale yellow colored, capsule shaped, film coated tablets debossed with 'C 24' on one side and plain on the other side and are available as follows: Bottles of 60 tablets                           NDC 33342-136-09 Bottles of 500 tablets                         NDC 33342-136-15 Quetiapine extended-release tablets,USP 400 mg 400 mg tablets are white to off white colored, capsule shaped, film coated tablets debossed with 'C 25' on one side and plain on the other side and are available as follows: Bottles of 60 tablets                           NDC 33342-137-09 Bottles of 500 tablets                         NDC 33342-137-15 Store at 20º to 25º C (68º to 77º F); excursions permitted to 15º to 30º C (59º to 86º F) [See USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

QUETIAPINE - QUETIAPINE TABLET, EXTENDED RELEASE
Macleods Pharmaceuticals Limited
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MEDICATION GUIDE
Quetiapine Extended-Release Tablets
(kwe-TYE-a-peen)
Read this Medication Guide before you start taking quetiapine
extended-release tablets and each time you
get a refill. There may be new information. This Medication Guide does
not take the place of talking to your
healthcare provider about your medical condition or treatment.
What is the most important information I should know about quetiapine
extended-release tablets?
Quetiapine extended-release tablets may cause serious side effects,
including:
1. risk of death in the elderly with dementia: Medicines like
quetiapine extended-release tablets can increase
the risk of death in elderly people who have memory loss (dementia).
Quetiapine extended-release 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:
o all risks and benefits of treatment with antidepressant medicines
o all treatment choices for depression or other serious mental illness
• Antidepressant medicines 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?
o 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 whe

Produkta apraksts

QUETIAPINE - QUETIAPINE TABLET, EXTENDED RELEASE
MACLEODS PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUETIAPINE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR QUETIAPINE
EXTENDED-RELEASE TABLETS.
QUETIAPINE EXTENDED-RELEASE 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 EXTENDED-RELEASE TABLETS
ARE 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 extended-release tablets
are an atypical antipsychotic indicated for the treatment of:
• Schizophrenia (1.1)
• Bipolar I disorder, manic, or mixed episodes (1.2)
• Bipolar disorder, depressive episodes (1.2)
• Major depressive disorder, adjunctive therapy with antidepressants
(1.3)
DOSAGE AND ADMINISTRATION
• Swallow tablets whole and do not split, chew or crush (2.1)
• Take without food or with a light meal (approx. 300 calories)
(2.1)
• Administer once daily, preferably in the evening (2.1)
• 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 starting dose (50 mg/day) and slower
titration may be needed (2.4 ,8.7,
12.3)
Indication
Initial Dose
Recommended Dose
Maximum Dose
Schizophrenia - Adults (2.2 )
300 m