All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. The structural formula is: Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water.
SEROQUEL is supplied for oral administration as 25 mg round, peach , 50 mg round, white , mg round, yellow , mg round, white , mg capsule-shaped, white , and mg capsule-shaped, yellow tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide.
The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the mg and mg tablets contain only yellow ferric oxide. 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 D2 and serotonin type 2 5HT2 antagonism.
Efficacy was established in two week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients years [see Clinical Studies Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [ see Clinical Studies Efficacy was established in two maintenance trials in adults. The effectiveness of SEROQUEL as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms.
It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment.
Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions. Of these approximately subjects, approximately in schizophrenia, in acute bipolar mania, in bipolar depression, and for the maintenance treatment of bipolar I disorder were patients who participated in multiple dose effectiveness trials, and their experience corresponded to approximately 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. However, discontinuations due to somnolence 0. Overall, discontinuations due to adverse reactions were 5. Renal impairment Dosage adjustment is not necessary in patients with renal impairment.
Hepatic impairment Quetiapine is extensively metabolised by the liver. Therefore, Seroquel XL should be used with caution in patients with known hepatic impairment, especially during the initial dosing period. Concomitant administration of cytochrome P 3A4 inhibitors, such as HIV-protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin and nefazodone, is contraindicated. Long-term efficacy and safety in patients with MDD has not been evaluated as add-on therapy, however long-term efficacy and safety has been evaluated in adult patients as monotherapy see section 5.
Paediatric population Quetiapine is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group. Clinical trials with quetiapine have shown that in addition to the known safety profile identified in adults see section 4. Changes in thyroid function tests have also been observed in children and adolescents.
Furthermore, the long-term safety implications of treatment with quetiapine on growth and maturation have not been studied beyond 26 weeks. Long-term implications for cognitive and behavioural development are not known. In placebo-controlled clinical trials with children and adolescent patients, quetiapine was associated with an increased incidence of extrapyramidal symptoms EPS compared to placebo in patients treated for schizophrenia, bipolar mania and bipolar depression see section 4. This risk persists until significant remission occurs.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. In addition, physicians should consider the potential risk of suicide-related events after abrupt cessation of quetiapine treatment, due to the known risk factors for the disease being treated.
Other psychiatric conditions for which quetiapine is prescribed can also be associated with an increased risk of suicide related events. In addition, these conditions may be co-morbid with major depressive episodes.
The same precautions observed when treating patients with major depressive episodes should therefore be observed when treating patients with other psychiatric disorders. Patients with a history of suicide related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta analysis of placebo controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.
Patients and caregivers of patients should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present. In shorter-term placebo controlled clinical studies of patients with major depressive episodes in bipolar disorder an increased risk of suicide-related events was observed in young adult patients younger than 25 years of age who were treated with quetiapine as compared to those treated with placebo 3.
In clinical studies of patients with MDD the incidence of suicide-related events observed in young adult patients younger than 25 years of age was 2. A population-based retrospective study of quetiapine for the treatment of patients with major depressive disorder showed an increased risk of self-harm and suicide in patients aged 25 to 64 years without a history of self-harm during use of quetiapine with other antidepressants.
Metabolic risk Given the observed risk for worsening of their metabolic profile, including changes in weight, blood glucose see hyperglycaemia and lipids, which was seen in clinical studies, patient's metabolic parameters should be assessed at the time of treatment initiation and changes in these parameters should be regularly controlled for during the course of treatment.
Worsening in these parameters should be managed as clinically appropriate see section 4. Extrapyramidal symptoms In placebo controlled clinical trials of adult patients quetiapine was associated with an increased incidence of extrapyramidal symptoms EPS compared to placebo in patients treated for major depressive episodes in bipolar disorder and major depressive disorder see sections 4.
The use of quetiapine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment.
In patients who develop these symptoms, increasing the dose may be detrimental. Tardive dyskinesia If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of quetiapine should be considered. The symptoms of tardive dyskinesia can worsen or even arise after discontinuation of treatment see section 4. Somnolence and dizziness Quetiapine treatment has been associated with somnolence and related symptoms, such as sedation see section 4.
In clinical trials for treatment of patients with bipolar depression and major depressive disorder, onset was usually within the first 3 days of treatment and was predominantly of mild to moderate intensity. Patients experiencing somnolence of severe intensity may require more frequent contact for a minimum of 2 weeks from onset of somnolence, or until symptoms improve and treatment discontinuation may need to be considered.
Orthostatic hypotension Quetiapine treatment has been associated with orthostatic hypotension and related dizziness see section 4. This could increase the occurrence of accidental injury fall , especially in the elderly population. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication. Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension.
Dose reduction or more gradual titration should be considered if orthostatic hypotension occurs, especially in patients with underlying cardiovascular disease.
Sleep apnoea syndrome Sleep apnoea syndrome has been reported in patients using quetiapine. Seizures In controlled clinical trials there was no difference in the incidence of seizures in patients treated with quetiapine or placebo.
No data is available about the incidence of seizures in patients with a history of seizure disorder. As with other antipsychotics, caution is recommended when treating patients with a history of seizures see section 4.
Neuroleptic malignant syndrome Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine see section 4. Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatine phosphokinase. In such an event, quetiapine should be discontinued and appropriate medical treatment given.
Most cases of severe neutropenia have occurred within a couple of months of starting therapy with quetiapine. There was no apparent dose relationship. During post-marketing experience, some cases were fatal.
Possible risk factors for neutropenia include pre-existing low white blood cell count WBC and history of drug induced neutropenia. However, some cases occurred in patients without pre-existing risk factors. Patients should be observed for signs and symptoms of infection and neutrophil counts followed until they exceed 1. Neutropenia should be considered in patients presenting with infection or fever, particularly in the absence of obvious predisposing factor s , and should be managed as clinically appropriate.
Such patients should have a WBC count and an absolute neutrophil count ANC performed promptly, especially in the absence of predisposing factors. Anti-cholinergic muscarinic effects Norquetiapine, an active metabolite of quetiapine, has moderate to strong affinity for several muscarinic receptor subtypes. This contributes to ADRs reflecting anti-cholinergic effects when quetiapine is used at recommended doses, when used concomitantly with other medications having anti-cholinergic effects, and in the setting of overdose.
Quetiapine should be used with caution in patients receiving medications having anti-cholinergic muscarinic effects. Quetiapine should be used with caution in patients with a current diagnosis or prior history of urinary retention, clinically significant prostatic hypertrophy, intestinal obstruction or related conditions, increased intraocular pressure or narrow angle glaucoma see sections 4.
Interactions See section 4. Concomitant use of quetiapine with a strong hepatic enzyme inducer such as carbamazepine or phenytoin substantially decreases quetiapine plasma concentrations, which could affect the efficacy of quetiapine therapy. In patients receiving a hepatic enzyme inducer, initiation of quetiapine treatment should only occur if the physician considers that the benefits of quetiapine outweigh the risks of removing the hepatic enzyme inducer. It is important that any change in the inducer is gradual, and if required, replaced with a non-inducer e.
Weight Weight gain has been reported in patients who have been treated with quetiapine, and should be monitored and managed as clinically appropriate as in accordance with utilised antipsychotic guidelines see sections 4.
In some cases, a prior increase in body weight has been reported which may be a predisposing factor. Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Patients treated with any antipsychotic agent including quetiapine, should be observed for signs and symptoms of hyperglycaemia, such as polydipsia, polyuria, polyphagia and weakness and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control. Weight should be monitored regularly.
Lipids Increases in triglycerides, LDL and total cholesterol, and decreases in HDL cholesterol have been observed in clinical trials with quetiapine see section 4. Lipid changes should be managed as clinically appropriate. QT prolongation In clinical trials and use in accordance with the SPC, quetiapine was not associated with a persistent increase in absolute QT intervals. In post-marketing, QT prolongation was reported with quetiapine at the therapeutic doses see section 4.
As with other antipsychotics, caution should be exercised when quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation. Also, caution should be exercised when quetiapine is prescribed either with medicines known to increase QT interval, or with concomitant neuroleptics, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia see section 4. Cardiomyopathy and myocarditis Cardiomyopathy and myocarditis have been reported in clinical trials and during the post-marketing experience, however, a causal relationship to quetiapine has not been established.
Treatment with quetiapine should be reassessed in patients with suspected cardiomyopathy or myocarditis. Withdrawal Acute withdrawal symptoms such as insomnia, nausea, headache, diarrhoea, vomiting, dizziness, and irritability have been described after abrupt cessation of quetiapine. Gradual withdrawal over a period of at least one to two weeks is advisable see section 4. Elderly patients with dementia-related psychosis Quetiapine is not approved for the treatment of dementia-related psychosis.
An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled trials in the dementia population with some atypical antipsychotics.
This could increase the occurrence of 400 injury fallseroquel 400 mg fiyat�, especially in the elderly population. In such an event, quetiapine should be discontinued and appropriate medical treatment given. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated fiyat� part of a total seroquel program that often includes psychological, educational and social interventions. The available evidence from placebo-controlled clinical trials is presented in sections 4. Cardiomyopathy and myocarditis Cardiomyopathy and myocarditis have been reported in clinical trials and during the post-marketing experience, however, a causal relationship to quetiapine has not been established. This information is costa allegra profile for fiyat� by health professionals 1. The pharmacokinetics of quetiapine were not altered following co-administration with cimetidine, seroquel 400 mg fiyat�. Misuse and abuse Cases of misuse and abuse have been reported. The recommended daily dose 400 mg. Patients should be observed for signs and symptoms of infection seroquel neutrophil counts followed until they exceed 1.
Such patients should have a WBC count and an absolute neutrophil count ANC performed promptly, especially in the absence of predisposing factors. Individual patients may benefit from a mg dose. In fiyat� multiple-dose trial in patients to assess the pharmacokinetics of quetiapine fiyat� before and during treatment with carbamazepine a known hepatic enzyme inducerco-administration of carbamazepine significantly increased the clearance of quetiapine. A population-based retrospective study of quetiapine for the treatment of patients with major depressive disorder showed an increased risk of self-harm and suicide 400 patients aged 25 to 64 seroquel without a history of self-harm during 400 of quetiapine with other augmentin available generic cost. Dysphagia Dysphagia see section 4. The daily dose at the start of therapy is 50 mg on Day 1 and 2, and seroquel on Day 3 and 4. It is general clinical experience that the risk of suicide may increase in the early stages of recovery, seroquel 400 mg fiyat�. Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, seroquel 400 mg fiyat�, autonomic instability, and increased creatine phosphokinase. Lactose Seroquel XL tablets contain lactose.
© Copyright 2017 Seroquel 400 mg fiyat� - yarborowinkle.com.