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Children and seroquel Adolescents: In acute placebo-controlled trials in professional children and seroquel adolescent patients with seroquel schizophrenia (6-week duration) or bipolar mania (3-week duration the incidence of seroquel shifts for thyroid function values at any time for Seroquel treated patients and seroquel placebo-treated. Age Oral clearance of professional quetiapine was reduced by 40 in elderly patients ( 65 years, n9) compared to young patients (n12 and dosing adjustment may be necessary see Dosage and Administration (2.3). Cataracts seizures abnormal thyroid tests. Decreased Hemoglobin Adults: In short-term placebo-controlled trials, decreases in hemoglobin to 13 g/dL males, 12 g/dL females on at least one occasion occurred.3 (594/7155) of quetiapine-treated patients compared.2 (219/3536) of patients treated with placebo. Table 11: Adverse Reaction Incidence in 8-Week Placebo-Controlled Clinical Trials for the Treatment of Bipolar Depression Preferred Term Seroquel (n698) placebo (n347) Somnolence 57 15 Dry Mouth 44 13 Dizziness 18 7 Constipation 10 4 Fatigue. Adverse Reactions Occurring at an Incidence of 2 among Seroquel Treated Patients in Short-Term, Placebo-Controlled Trials Schizophrenia (Adolescents, 13- 17 years old) The following findings were seroquel based on a 6-week placebo-controlled trial in which quetiapine was administered in either doses of 400 or 800 mg/day. Gender There is no gender effect on the pharmacokinetics of quetiapine. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Leukopenia/Neutropenia Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should professional be advised that professional they should have their CBC monitored while taking Seroquel. In Table 12, dystonic event included nuchal rigidity, hypertonia, dystonia, muscle rigidity, oculogyration; parkinsonism included cogwheel rigidity, tremor, drooling, hypokinesia; akathisia included akathisia, psychomotor agitation; dyskinetic event included tardive dyskinesia, dyskinesia, choreoathetosis; and other extrapyramidal event included restlessness, extrapyramidal disorder, movement disorder. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. 5 seroquel Tardive dyskinesia see Warnings and Precautions.6 Hypotension see Warnings and Precautions.7 Falls see Warnings and Precautions.8 Increases in blood pressure (children and adolescents) see Warnings and Precautions.9 Leukopenia, neutropenia seroquel and agranulocytosis see Warnings and Precautions. 150-750 mg/day 750 mg/day Schizophrenia- Adolescents (13-17 years) Day 1: 25 mg twice daily. If signs and symptoms of tardive dyskinesia appear in a patient on Seroquel, drug discontinuation should be considered. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Table 10 enumerates the incidence, rounded to the nearest percent, of adverse reactions that occurred during therapy (up to 3 weeks) of acute mania in 2 or more of patients treated with Seroquel (doses ranging from 100 to 800. The mean change in body weight was.4 kg in the Seroquel XR group. One case, involving an estimated overdose of 9600 mg, was associated with hypokalemia and first-degree heart block. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Gradual withdrawal is advised. Day 4: Twice daily dosing totaling 300. Changes in TSH, thyroxine, and thyroxine clearance consistent with this mechanism were observed in subchronic toxicity studies in rat and mouse and in a 1-year toxicity study in rat; however, the results of these studies were not definitive. 400-600 mg/day 600 mg/day Bipolar Depression- Adults Administer once daily at bedtime. Store Seroquel at room temperature, between 68F to 77F (20C to 25C). In addition, fetal weights were decreased in both species. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects. Smoking Smoking has no effect on the oral seroquel clearance of quetiapine. Day 1: 50 mg Day 2: 100 mg Day 3: 200 mg Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy- Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue Seroquel at the first. 0.6 kg in the placebo group. Antagonism at receptors other than dopamine and 5HT2 with similar receptor affinities may explain some of the other effects of Seroquel. The complete text of the Medication Guide is reprinted at the end of this document. The conditions and duration of treatment with Seroquel varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, seroquel inpatients and outpatients, fixed-dose and dose-titration studies, and short-term or longer-term exposure. In limited published literature, there were no major malformations associated with quetiapine exposure during pregnancy. In acute bipolar mania trials in adults, the proportions of patients with transaminase elevations of 3 times the upper limits of the normal reference range in a pool of 3- to 12-week placebo-controlled trials were approximately 1 for both Seroquel (3/560) and placebo (3/294). No effect on absorption or mean oral clearance Thioridazine 200 mg twice daily 300 mg twice daily 65 increase in oral clearance Cimetidine 400 mg three times daily for 4 days 150 mg three times daily 20 decrease in mean oral clearance. The patient should be carefully monitored since recurrences of NMS have been reported. In acute bipolar mania trials using Seroquel as adjunct therapy, somnolence was reported in 34 (66/196) of patients on Seroquel compared to 9 (19/203) of placebo patients. Further adjustments can be made in increments of 2550 mg twice a day, in intervals seroquel of not less than 2 days. A patient Medication Guide about Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions is available for Seroquel. In patients who do require chronic treatment, the smallest dose seroquel and the shortest duration of treatment producing a satisfactory clinical response should be sought. Intestinal obstruction has been reported with quetiapine, including fatal reports in patients who were receiving multiple concomitant medications that decrease intestinal motility. Hyperlipidemia Patients should be advised that elevations in total cholesterol, LDL-cholesterol and triglycerides and decreases in HDL-cholesterol may occur. If hypotension professional occurs during titration to the target dose, a return to the previous dose in the titration schedule is appropriate. Seroquel is not approved for the treatment of patients with dementia-related psychosis see Boxed Warning. About.7 (26/3489) of Seroquel patients did experience TSH increases seroquel in monotherapy studies. However, when adjusted for dose and weight, AUC and Cmax of the parent compound were 41 and 39 lower, respectively, in children and adolescents than in adults.