Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and non-psychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, 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. Table 19 shows the percentage of patients experiencing adverse reactions associated with EPS in adjunct clinical trials for MDD by dose: The information below is derived from a clinical trial database for SEROQUEL consisting of over 1000 pediatric patients. The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]. During clinical trials with SEROQUEL, seizures occurred in 0.5% (20/3490) of patients treated with SEROQUEL compared to 0.2% (2/954) on placebo. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Bipolar Disorder, Depressive Episode: In a single clinical trial in patients with bipolar depression, 14% (19/137) of patients on SEROQUEL XR discontinued due to an adverse reaction compared to 4% (5/140) on placebo. It may change the way your heart beats and cause fainting or serious side effects. For people with severe constipation: Quetiapine can cause constipation and increase your risk of gastrointestinal problems including bowel block. These doses are equivalent to 0.1, 0.5, 1.5, and 4.5 times the MRHD of 800 mg/day based on mg/m2 body surface area (mice) or 0.3, 1, and 3 times the MRHD based on mg/m2 body surface area (rats). Table 14 enumerates the incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy of bipolar depression (up to 8 weeks) in 2% or more of adult patients treated with SEROQUEL XR 300 mg/day where the incidence in patients treated with SEROQUEL XR was greater than the incidence in placebo-treated patients. In acute placebo-controlled trials in children and adolescent patients with bipolar mania (3-week duration) or schizophrenia (6-week duration), the incidence of shifts in prolactin levels to a value (>20 g/L males; >26 g/L females at any time) was 13.4% (18/134) for SEROQUEL compared to 4% (3/75) for placebo in males and 8.7% (9/104) for SEROQUEL compared to 0% (0/39) for placebo in females. There is no general agreement about specific pharmacological treatment regimens for NMS. Seroquel and its metabolites are non-inhibitors of major metabolizing CYPs (1A2, 2C9, 2C19, 2D6, and 3A4). A prescription for this medication is refillable. Somnolence2 was the only adverse reaction leading to discontinuation that occurred at an incidence of 2% in SEROQUEL XR in MDD trials. Stay out of the sun. Labels, All Index 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. Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should be advised that they should have their CBC monitored while taking SEROQUEL XR. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. Atypical antipsychotic drugs, including SEROQUEL XR, may cause somnolence, postural hypotension, motor, and sensory instability, which may lead to falls and, consequently, fractures or other injuries. Check your blood sugar closely and talk with your doctor if you have any questions. The clastogenic potential of quetiapine was tested in the in vitro chromosomal aberration assay in cultured human lymphocytes and in the in vivo bone marrow micronucleus assay in rats up to 500 mg/kg which is 6 times the MRHD based on mg/m2 body surface area. Dont take this drug again if youve ever had an allergic reaction to it. Patients should be advised that they may experience weight gain. Increases in blood sugar can happen in some people who take SEROQUEL XR. In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks), including fatalities, compared to placebo-treated subjects. You can ask your pharmacist or healthcare provider for information about SEROQUEL XR that is written for health professionals. There also was a 25% reduction in cholesterol content of the outer cortex of the lens observed in a special study in quetiapine treated female dogs. Always speak with your doctor or pharmacist about dosages that are right for you. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. Brand names: Seroquel and Seroquel XR. Seroquel is an antipsychotic that helps to calm and relieve psychotic thoughts. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. (4). Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Patients should be advised of the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing, which may lead to falls) especially during the period of initial dose titration, and also at times of re-initiating treatment or increases in dose [see Warnings and Precautions (5.7)]. Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents. Quetiapine adversely affected mating and fertility in female Sprague-Dawley rats at an oral dose approximately 1 times the MRHD of 800 mg/day based on mg/m2 body surface area. Quetiapine extended-release tablet is also used together with other antidepressants to treat major depressive disorder. What are possible side effects of SEROQUEL XR? Precise risk estimates for hyperglycemia-related adverse reactions in patients treated with atypical antipsychotics are not available. SEROQUEL XR should be used with caution in patients receiving medications having anticholinergic (antimuscarinic) effects [see Drug Interactions (7.1), Overdosage(10.1), and Clinical Pharmacology (12.1)]. Quetiapine may make it more difficult for your body to cool down. See full prescribing information for SEROQUEL XR. 0310-0284-60, Laboratory, ECG and vital sign changes observed in clinical studies. At steady state, the pharmacokinetics of the parent compound, in children and adolescents (10-17 years of age), were similar to adults. Endoscopic pharmacobezoar removal has been performed successfully. Low white blood cell count. However, the QT effect was not systematically evaluated in a thorough QT study. However, the dose is usually not more than 800 mg per day. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Of the SEROQUEL treated patients with elevated TSH levels, 1 had simultaneous low free T4 level at end of treatment. Events, (What The efficacy of SEROQUEL XR as adjunctive therapy to antidepressants in the treatment of MDD was demonstrated in two 6-week placebo-controlled, fixed-dose trials (n=936). The results of some tests (eg, urine drug screens) may be affected by this medicine. Dosage adjustment is therefore not needed in these patients [see Use in Specific Populations (8.6)]. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Generic name: quetiapine Brand names: Seroquel, Seroquel XR Dosage form: oral tablet, oral extended-release tablet Drug class: Atypical antipsychotics Medically reviewed by Judith Stewart, BPharm. Quetiapine is extensively metabolized by the liver. Your doctor may start you at a dosage of 50 mg daily. 0310-0283-60, The efficacy of SEROQUEL in the treatment of acute manic episodes was also established in 3 placebo-controlled trials in patients who met DSM-IV criteria for bipolar I disorder with manic episodes. Hyperprolactinemia, regardless of etiology, may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotrophin secretion. Safety and effectiveness of SEROQUEL XR in pediatric patients less than 13 years of age with schizophrenia have not been established. They cant harm your medication. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking SEROQUEL XR. Somnolence was dose-related in these trials (37% (117/315) and 43% (135/312) for the 150 mg and 300 mg groups, respectively). In two placebo-controlled short-term adjunctive therapy clinical trials for the treatment of MDD utilizing between 150 mg and 300 mg of SEROQUEL XR, the incidence of any adverse reactions related to EPS was 5.1% for SEROQUEL XR and 4.2% for the placebo group. They are used in patients with schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs). The total dosage would be taken twice daily. Coadministration of quetiapine and phenytoin, a CYP3A4 inducer increased the mean oral clearance of quetiapine by 5-fold. 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. Ambien and Ambien CR are prescription tablets used to treat insomnia in adults. Seroquel XR. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. Quetiapine should also be avoided in circumstances that may increase the risk of occurrence of torsade de pointes and/or sudden death including (1) a history of cardiac arrhythmias such as bradycardia; (2) hypokalemia or hypomagnesemia; (3) concomitant use of other drugs that prolong the QTc interval; and (4) presence of congenital prolongation of the QT interval. This has been deadly in people taking this drug with other drugs that slow movement through your gastrointestinal tract. General information about the safe and effective use of SEROQUEL XR. Do not take other medicines unless they have been discussed with your doctor. The diagnostic evaluation of patients with this syndrome is complicated. Tell the healthcare provider about all the medicines that you take or recently have taken. SEROQUEL XR was superior to placebo in reduction of MADRS score at week 8 (Study 6 in Table 28). Your doctor should monitor your blood thyroid hormone levels before and during treatment with this drug. By Duff Wilson July 18, 2011 AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company. SEROQUEL XR tablets should be swallowed whole and not split, chewed, or crushed. The efficacy of SEROQUEL XR for the acute treatment of depressive episodes associated with bipolar disorder in patients who met DSM-IV criteria for bipolar disorder was established in one 8-week, randomized, double-blind, placebo-controlled study (N=280 outpatients). 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. Quetiapine may induce orthostatic hypotension associated with dizziness, tachycardia and, in some patients, syncope, especially during the initial dose-titration period, probably reflecting its 1-adrenergic antagonist properties. The primary endpoint was the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment (Day 42). Adults: Table 8 shows the percentage of adult patients with weight gain of 7% of body weight by indication. 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