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Treatment of schizophrenia, depressive episodes associated w/ bipolar disorder, acute manic episodes associated w/ bipolar I disorder, as either monotherapy or adjunct to lithium or divalproex. Maintenance treatment of bipolar I disorder as adjunct therapy to lithium or divalproex.


Adverse reactions:

Dizziness, somnolence, leucopenia, tachycardia, dry mouth, constipation, dyspepsia, mild asthenia, peripheral edema, wt gain, ALT/AST elevations, decreased neutrophil count, increased blood glucose levels, syncope, rhinitis, orthostatic hypotension.


Alcohol, CNS-acting drugs Possible additive CNS depressant effects; use with caution. Avoid alcohol. Antihypertensive agents Hypotensive effects may be enhanced. Cimetidine Quetiapine concentrations may be increased slightly; dosage adjustment does not appear to be needed. Divalproex Quetiapine concentrations may be increased. Dopamine agonists (eg, pramipexole, ropinirole), levodopa Quetiapine may antagonize therapeutic effects of dopamine agonists and levodopa. Dopamine/Epinephrine Do not use dopamine, epinephrine, or other sympathomimetics with beta-agonist activity for the treatment of quetiapine-induced hypotension. Inducers of CYP3A (eg, barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin) May decrease the effects of quetiapine; increased doses of quetiapine may be necessary to maintain control of psychotic symptoms. Quetiapine may increase the plasma concentrations of the active metabolite of carbamazepine, resulting in neurotoxicity. Inhibitors of CYP3A (eg, erythromycin, fluconazole, fluvoxamine, itraconazole, ketoconazole, protease inhibitors, voriconazole) May increase the effects of quetiapine; use with caution. Lorazepam Quetiapine increases the effects of lorazepam. Thioridazine May decrease the effects of quetiapine.


Warnings Increased mortality Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Over the course of a 10-wk controlled trial, the rate of death in drug-treated patients was about 4.5% compared with 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either CV (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Quetiapine is not approved for the treatment of patients with dementia-related psychosis. Suicidality Compared with placebo, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorders and other psychiatric disorders. Appropriately monitor patients of all ages who are started on antidepressant therapy and observe them closely for clinical worsening, suicidality, or unusual changes in behavior. Advise families and caregivers of the need for close observation and communication with the prescriber. Quetiapine is not approved for use in children. Monitor Monitor all patients for the emergence of agitation, irritability, clinical worsening, and other unusual changes in behavior, as well as the emergence of suicidality, especially during the initial few months of therapy or at times of dose changes. Monitor patients for symptoms of hyperglycemia. Perform fasting glucose testing in patients who develop hyperglycemia during treatment. Ensure that patients with risk factors for diabetes undergo fasting blood glucose testing at the start of therapy and periodically thereafter. Monitor patients with established diagnosis of diabetes mellitus regularly for worsening of glucose control. Perform eye exam at initiation of therapy to detect cataract formation and at 6-mo intervals during long-term treatment. Monitor patients for any unusual changes in behavior (eg, agitation, irritability). Monitor patients requiring antipsychotic drug treatment after recovery from NMS for recurrence of NMS if quetiapine therapy is reintroduced. Monitor WBC frequently during the first few months of therapy in patients with a preexisting low WBC or history of drug-induced leukopenia/neutropenia. Carefully monitor patients with neutropenia for fever or other symptoms or signs of infection. Pregnancy Category C . Lactation Excreted. Children Safety and efficacy not established; not approved for use in children. Elderly May be more susceptible to effects. Consider lower starting dose, slower titration, and careful monitoring. May be at increased risk of tardive dyskinesia, especially elderly women. Hepatic Function Dosage adjustment may be needed. Special Risk Patients Consider lower starting dose, slower titration, and careful monitoring in debilitated patients and patients with predisposition to hypotensive reactions. Body temperature regulation Antipsychotics can disrupt the body’s ability to reduce core temperature. Cardiac effects Orthostatic hypotension may occur, especially during the initial dose-titration period. Use with caution in patients with known cardiovascular disease (eg, conduction abnormalities, heart failure, history of MI, ischemic heart disease), cerebrovascular disease, or condition that would predispose patients to hypotension (eg, dehydration, hypovolemia, treatment with antihypertensive medications). Cataracts Lens changes have been observed in patients during long-term treatment. Cognitive and motor performance Mental and/or physical abilities may be impaired, especially during the first few days of therapy. Dysphagia Antipsychotics have been associated with esophageal dysmotility and aspiration. Use with caution in patients at risk for aspiration pneumonia. Hematologic effects Agranulocytosis (including fatal cases), leukopenia, and neutropenia have been reported during postmarketing experience. Hyperglycemia and diabetes mellitus Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, may occur. Hyperlipidemia Increased cholesterol and/or triglycerides may occur. Hyperprolactinemia Patients treated with antipsychotic agents often have elevation in prolactin levels. Hypothyroidism May occur. NMS Has occurred with antipsychotics and is potentially fatal.



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