Medically reviewed on February 1, Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions 5. Seroquel is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions 5. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies.
These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions 5. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [ see Warnings and Precautions 5.
Seroquel is not approved for use in pediatric patients under ten years of age [see Use in Specific Populations 8. Seroquel is indicated for the treatment of schizophrenia. The efficacy of Seroquel in schizophrenia was established in three 6-week trials in adults and gaugler and alzheimers and seroquel 6-week trial in adolescents years. The effectiveness of Seroquel for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies Seroquel is 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 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 Seroquel is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder, gaugler and alzheimers and seroquel. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies Seroquel is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex.
Efficacy was established in two maintenance trials in adults, gaugler and alzheimers and seroquel. 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 Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. 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.
The recommended initial dose, titration, dose range and maximum Seroquel dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies Increase in increments of 25 mg mg divided two or three times on Days 2 and 3 to range of mg by Day 4.
Further adjustments can be made in increments of 25—50 mg twice a day, in intervals of not gaugler and alzheimers and seroquel than 2 days. Generally, gaugler and alzheimers and seroquel, in the maintenance phase, patients continued on the same dose on which they were stabilized. Maintenance Treatment — Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients keppra xr and dilantin are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology When indicated, dose escalation should be performed with caution in these patients.
Seroquel dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor e, gaugler and alzheimers and seroquel. Seroquel dose should be increased up to 5-fold of the original dose when used in combination with a chronic treatment e. The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of Seroquel should be reduced to the original level within days [see Clinical Pharmacology Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off Seroquel for more than one week, the initial dosing schedule should be followed.
When restarting patients who have been off Seroquel for less than one week, gradual dose escalation may not be required and the maintenance dose may be re-initiated. 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.
Hypersensitivity to quetiapine or to any excipients in the Seroquel formulation, gaugler and alzheimers and seroquel. Anaphylactic reactions have been reported in patients treated with Seroquel. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analysis of 17 placebo-controlled trials modal duration of 10 weekslargely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.
Over the course of a typical week controlled trial, the rate of death in drug-treated patients was about 4. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular e. 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 is not approved for the treatment of patients with dementia-related psychosis [ see Boxed Warning ]. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.
There has been a long-standing female virgo and male cancer, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.
Pooled analyses of short-term placebo-controlled trials of antidepressant drugs SSRIs and others showed that these drugs increase the risk of suicidal thinking and behavior suicidality in children, adolescents, and young adults ages with major depressive disorder MDD and other psychiatric disorders.
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 with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive-compulsive disorder OCDor other psychiatric disorders included gaugler and alzheimers and seroquel total of 24 short-term trials of 9 antidepressant drugs in over patients.
The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of short-term trials median duration of 2 months of 11 antidepressant drugs in over 77, patients. There was considerable variation in risk of suicidality among drugs, gaugler and alzheimers and seroquel, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD.
The risk differences drug vs. These risk differences drug-placebo difference in the number of cases of suicidality per patients treated are provided in Table 2. No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, gaugler and alzheimers and seroquel, akathisia psychomotor restlessnesshypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, gaugler and alzheimers and seroquel, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers.
Such monitoring should include daily observation by families gaugler and alzheimers and seroquel caregivers. Prescriptions for Seroquel should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, gaugler and alzheimers and seroquel, prior to initiating treatment with gaugler and alzheimers and seroquel antidepressant, including Seroquel, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, gaugler and alzheimers and seroquel, bipolar disorder, and depression.
In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly gaugler and alzheimers and seroquel with dementia, there was a higher incidence of cerebrovascular adverse reactions cerebrovascular accidents and transient ischemic attacks including fatalities compared gaugler and alzheimers and seroquel placebo-treated subjects.
Seroquel is not approved for the treatment of patients with dementia-related psychosis [see also Boxed Warning and Warnings and Precautions 5. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome NMS has been reported in association with administration of antipsychotic drugs, including Seroquel.
Rare cases of NMS have been reported with Seroquel. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia.
Additional signs may include elevated creatinine phosphokinase, myoglobinuria rhabdomyolysis and acute renal failure. The diagnostic evaluation of patients with this syndrome is complicated.
In arriving at a diagnosis, it is important to exclude cases where the clinical presentation includes both serious medical illness e. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system CNS pathology.
The management of NMS should include: There is no general agreement about specific pharmacological treatment regimens for NMS. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered.
The patient should be carefully monitored since recurrences of NMS have been reported. While all of indomethacin and colchicine for gout drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.
Onions and sulfur allergies some patients, a worsening of more than one of the metabolic parameters of weight, blood glucose, and lipids was observed in clinical studies. Changes in these metabolic profiles should be managed as clinically appropriate. Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including quetiapine.
Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population.
Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse reactions is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse reactions in patients treated with the atypical antipsychotics.
Precise risk estimates for hyperglycemia-related adverse reactions in patients treated with atypical antipsychotics are not lactose intolerance and diabetes. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should gaugler and alzheimers and seroquel monitored regularly for worsening of glucose control, gaugler and alzheimers and seroquel.
Patients with risk factors for diabetes mellitus e. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing.
In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.