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Seroquel
Overview
What is Seroquel?
1
What does Seroquel look like?
What are the available doses of Seroquel?
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What should I talk to my health care provider before I take Seroquel?
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How should I use Seroquel?
2 DOSAGE AND ADMINISTRATION
Adolescents (13-17 years)
The
total daily dose for the initial five days of therapy is 50 mg (Day 1), 100 mg
(Day 2), 200 mg (Day 3), 300 mg (Day 4) and 400 mg (Day 5). After Day 5, the
dose should be adjusted within the recommended dose range of 400 mg/day to 800
mg/day based on response and tolerability. Dosage adjustments should be in
increments of no greater than 100 mg/day. Efficacy was demonstrated with
SEROQUEL at both 400 mg and 800 mg; however, no additional benefit was seen in
the 800 mg group.
Maintenance Treatment
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection
In these clinical trials supporting effectiveness, the dosing schedule was 50
mg, 100 mg, 200 mg and 300 mg/day for Days 1-4 respectively. Patients receiving
600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant
efficacy was demonstrated with SEROQUEL at both 300 mg and 600 mg; however, no
additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with SEROQUEL
(administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to
lithium or divalproex. Generally, in the maintenance phase, patients continued
on the same dose on which they were stabilized during the stabilization phase
[ (14.2)].
Acute Treatment of Manic
Episodes in Bipolar I Disorder
Dose Selection
The
total daily dose for the initial five days of therapy is 50 mg (Day 1), 100 mg
(Day 2), 200 mg (Day 3), 300 mg (Day 4) and 400 mg (Day 5). After Day 5, the
dose should be adjusted within the recommended dose range of 400 to 600 mg/day
based on response and tolerability. Dosage adjustments should be in increments
of no greater than 100 mg/day. Efficacy was demonstrated with SEROQUEL at both
400 mg and 600 mg; however, no additional benefit was seen in the 600 mg
group.
Maintenance Treatment of Bipolar I
Disorder
The
effectiveness of SEROQUEL for longer than 3 weeks has not been evaluated in
controlled clinical trials of children and adolescents. While there is no body
of evidence available to answer the question of how long the patient treated
with SEROQUEL should be maintained, it is generally recommended that responding
patients be continued beyond the acute response, but at the lowest dose needed
to maintain remission. Patients should be periodically reassessed to determine
the need for maintenance treatment.
Consideration should be given to a slower rate of dose titration
and a lower target dose in the elderly and in patients who are debilitated or
who have a predisposition to hypotensive reactions [ (12)]. When
indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose
should be increased daily in increments of 25 mg/day – 50 mg/day to an effective
dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation
of treatment, it is recommended that when restarting patients who have had an
interval of less than one week off SEROQUEL, titration of SEROQUEL is not
required and the maintenance dose may be reinitiated. When restarting therapy of
patients who have been off SEROQUEL for more than one week, the initial
titration schedule should be followed.
There are no systematically collected data to specifically
address switching patients with schizophrenia from antipsychotics to SEROQUEL,
or concerning concomitant administration with antipsychotics. While immediate
discontinuation of the previous antipsychotic treatment may be acceptable for
some patients with schizophrenia, more gradual discontinuation may be most
appropriate for others. In all cases, the period of overlapping antipsychotic
administration should be minimized. When switching patients with schizophrenia
from depot antipsychotics, if medically appropriate, initiate SEROQUEL therapy
in place of the next scheduled injection. The need for continuing existing EPS
medication should be re-evaluated periodically.
What interacts with Seroquel?
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What are the warnings of Seroquel?
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What are the precautions of Seroquel?
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What are the side effects of Seroquel?
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What should I look out for while using Seroquel?
Boxed Warning
Elderly patients with dementia-related psychosis
treated with antipsychotic drugs are at an increased risk of death. Analyses of
seventeen placebo-controlled trials (modal duration of 10 weeks) largely in
patients taking atypical antipsychotic drugs, revealed a risk of death in
drug-treated patients of between 1.6 to 1.7 times the risk of death in
placebo-treated patients. Over the course of a typical 10-week controlled trial,
the rate of death in drug-treated patients was about 4.5%, compared to a rate of
about 2.6% in the placebo group. Although the causes of death were varied, most
of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden
death) or infectious (e.g., pneumonia) in nature. Observational studies suggest
that, similar to atypical antipsychotic drugs, treatment with conventional
antipsychotic drugs may increase mortality. The extent to which the findings of
increased mortality in observational studies may be attributed to the
antipsychotic drug as opposed to some characteristic(s) of the patients is not
clear. SEROQUEL (quetiapine) is not approved for the treatment of patients with
dementia-related psychosis [
(5.1)].
Antidepressants increased the risk compared to
placebo of suicidal thinking and behavior (suicidality) in children,
adolescents, and young adults in short-term studies of major depressive disorder
(MDD) and other psychiatric disorders. Anyone considering the use of SEROQUEL or
any other antidepressant in a child, adolescent, or young adult must balance
this risk with the clinical need. Short-term studies did not show an increase in
the risk of suicidality with antidepressants compared to placebo in adults
beyond age 24; there was a reduction in risk with antidepressants compared to
placebo in adults aged 65 and older. Depression and certain other psychiatric
disorders are themselves associated with increases in the risk of suicide.
Patients of all ages who are started on antidepressant therapy should be
monitored appropriately and observed closely for clinical worsening,
suicidality, or unusual changes in behavior. Families and caregivers should be
advised of the need for close observation and communication with the prescriber.
SEROQUEL is not approved for use in patients under ten years of age
see
What might happen if I take too much Seroquel?
10 OVERDOSAGE
10.1 Human Experience
10.2 Management of Overdosage
How should I store and handle Seroquel?
GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°–30°C (59°–86°F) or up to 7 days refrigerated, 2°–8°C (36°–46°F).Zenchent® (norethindrone and ethinyl estradiol tablets USP, 28-Day) are packaged in cartons of 6 blister cards. Each blister card contains 21 orange tablets impressed with on one side and on the other side, and 7 white tablets impressed with on one side and on the other side.Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Zenchent® (norethindrone and ethinyl estradiol tablets USP, 28-Day) are packaged in cartons of 6 blister cards. Each blister card contains 21 orange tablets impressed with on one side and on the other side, and 7 white tablets impressed with on one side and on the other side.Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of SEROQUEL, as with other drugs having
efficacy in the treatment of schizophrenia and bipolar disorder, is unknown.
However, it has been proposed that the efficacy of SEROQUEL in schizophrenia and
its mood stabilizing properties in bipolar depression and mania are mediated
through a combination of dopamine type 2 (D) and
serotonin type 2 (5HT) antagonism. Antagonism at
receptors other than dopamine and 5HT with similar
receptor affinities may explain some of the other effects of SEROQUEL.
SEROQUEL’s antagonism of histamine H receptors may
explain the somnolence observed with this drug.
Non-Clinical Toxicology
Boxed WarningElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. SEROQUEL (quetiapine) is not approved for the treatment of patients with dementia-related psychosis [ (5.1)].
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of SEROQUEL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SEROQUEL is not approved for use in patients under ten years of age
see
Adults
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The information below is derived from a clinical trial database for SEROQUEL consisting of over 4300 patients. This database includes 698 patients exposed to SEROQUEL for the treatment of bipolar depression, 405 patients exposed to SEROQUEL for the treatment of acute bipolar mania (monotherapy and adjunct therapy), 646 patients exposed to SEROQUEL for the maintenance treatment of bipolar I disorder as adjunct therapy, and approximately 2600 patients and/or normal subjects exposed to 1 or more doses of SEROQUEL for the treatment of schizophrenia.
Of these approximately 4300 subjects, approximately 4000 (2300 in schizophrenia, 405 in acute bipolar mania, 698 in bipolar depression, and 646 for the maintenance treatment of bipolar I disorder) were patients who participated in multiple dose effectiveness trials, and their experience corresponded to approximately 2400 patient-years. The conditions and duration of treatment with SEROQUEL varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, fixed-dose and dose-titration studies, and short-term or longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.
Adverse reactions during exposure were obtained by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized reaction categories.
In the tables and tabulations that follow, standard COSTART terminology has been used to classify reported adverse reactions for schizophrenia and bipolar mania. MedDRA terminology has been used to classify reported adverse reactions for bipolar depression.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Incidence of Adverse Reactions in Short-Term, Placebo-Controlled Trials in Adults
Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials:
Schizophrenia:
see
Bipolar Disorder:
Mania:
Depression:
Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials:
In the acute therapy of schizophrenia (up to 6 weeks) and bipolar mania (up to 12 weeks) trials, the most commonly observed adverse reactions associated with the use of SEROQUEL monotherapy (incidence of 5% or greater) and observed at a rate on SEROQUEL at least twice that of placebo were somnolence (18%), dizziness (11%), dry mouth (9%), constipation (8%), ALT increased (5%), weight gain (5%), and dyspepsia (5%).
Adverse Reactions Occurring at an Incidence of 1% or More Among SEROQUEL Treated Patients in Short-Term, Placebo-Controlled Trials:
The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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