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Important Safety Information About SEROQUEL XR Either immediate-release or extended-release tablets may be given; dosage titrated upward over 4 days Day 1: 50 mg PO at bedtime Day 2: 100 mg PO at bedtime Day 3: 200 mg PO at bedtime Maintenance (day 4 onward): 300 mg PO at bedtime Administered as adjunct to lithium or divalproex Immediate release: 400-800 mg/day PO divided q12hr Extended release: 400-800 mg/day PO in single dose Generally, in maintenance phase, patients continue to receive same dosage on which they were stabilized Dizziness (1-18%) Fatue (3-14%) Extrapyramidal symptoms (1-13%) Increased diastolic blood pressure (41%) Increased trlycerides (8-22%) Increased total cholesterol (7-18%) Increased appetite (2-12%) Constipation (6-11%) Dry mouth (9-44%) Headache (7-21) Somnolence (18-57%) Abdominal pain (4-7%; dose related) Dyspepsia (2-7%; dose related Tremor (2-8%) Back pain (3-5%) Postural hypotension (2-7%) Tachycardia (1-6%) Pharyngitis (4-6%) Rhinitis (3-4%) Rash (4%) Blurred vision (1-4%) Arthralgia (1-4%) Myalgia (2%) Neck pain (2%) Dyskinesia (4%) Neutropenia (2%) Hemorrhage (1%) Not approved for dementia-related psychosis; elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders; prescriptions should be written for smallest therapeutiy effective quantity, and caregivers should monitor and report to healthcare professionals incidence of suicidality and associated behaviors Not approved for children Use with caution in cardiovascular and cerebrovascular disease May worsen hypotensive conditions Use with caution in breast cancer and history of seizure Increased risk of hyperglycemia and diabetes; in some cases, hyperglycemia concomitant with use of atypical antipsychotics has been associated with ketoacidosis, hyperosmolar coma, or death; monitor blood glucose of hh-risk patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness; monitor glucose regularly in patients with diabetes or at risk for diabetes Increased incidence of cerebrovascular adverse effects, including stroke and TIAs, in elderly with dementia (not approved for the treatment of patients with dementia-related psychosis); see Black Box Warnings Neuroleptic malnant syndrome (NMS) reported with use Tardive dyskinesia possible after discontinuance Clinical worsening of depression and suicide ideation may occur despite treatment Hyperlipidemia may occur; appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodiy, during treatment Weht gain may occur; monitoring of weht recommended Orthostatic hypotension associated with use Monitor for cataract Increased blood pressure in children and adolescents reported; monitor blood pressure at the beginning of, and periodiy during treatment Leukopenia, neutropenia, and agranulocytosis may occur Somnolence may occur (especially with extended-release product) Potential for withdrawal symptoms after abrupt discontinuance False-positive urine drug screens reported when immunoassays for methadone or tricyclic antidepressants used FDA warning regarding off-label use for dementia in elderly (see Black Box Warnings) Pregnancy category: C Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk for extrapyramidal symptoms (EPS) or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU support and prolonged hospitalization Lactation: Drug excreted in breast milk; breastfeeding not recommended Atypical antipsychotic related to clozapine; reduces positive and negative symptoms of psychotic disorders via antagonism of multiple neurotransmitter receptors in brain, including dopamine D1 and D2, histamine H1, alpha1- and alpha2-adrenergic, and serotonin types 1 and 2 (5-HT1A, 5-HT2); has no affinity for benzodiazepine and cholinergic muscarinic receptors The above information is provided for general informational and educational purposes only. Bipolar Disorder Information SEROQUEL XR® quetiapine fumarate Savings Card;. Flag This product information is intended for US Health Care Professionals only.

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An Overview of Risk Quetiapine is an antipsychotic which works by changing the balance of chemicals in the brain, improving symptoms of certain mental conditions affecting thinking, feelings and behaviour. The rapid growth in the use of and reliance on information technology raises a number of new risks. Source Future Pharma, KPMG 2011. 2001. 2002. 2003erythropoietin stimulating agents ESAs Seroquel product liability litation and state attorney general investation of sales and marketing.

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