Version Date: 8/1/2017 WEBMBLA-0003-17 Applies to the Louisiana Medicaid market . 1. 8. FDA drug safety communication: Antipsychotic drug labels updated in use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns. Your doctor may start you at a dosage of 50 mg daily. 1. Any dryness and irritation usually subsides after about 4 weeks. This depends on your condition and whether or not you are taking any other medicines.Seroquel is usually started at a low dose that will be gradually increased by your doctor. In: Holliday SG, Ancill RJ, MacEwan GW eds. American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Rockville, MD; 2007 May 2. Meltzer HY. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Mahmoud RA. 10. A comparison of quetiapine and chlorpromazine in the treatment of schizophrenia. During the 26 week open-label clinical trial, one child with a reported history of hypertension experienced a hypertensive crisis. Select one or more newsletters to continue. 61. From the FDA web site. Koller EA, Cross JT, Doraiswamy PM et al. Which atypical antipsychotic for schizophrenia?. Indianapolis, IN; 2003 Sep 17. Keep Differin in your daily routine for continued improvement. 9. 14. 15. Copolov DL, Link CGG, Kowalcyk B. We comply with the HONcode standard for trustworthy health information - 67. Small JG, Hirsch SR, Arvanitis LA et al and the Seroquel Study Group. 78. Sachs G, Chengappa KN, Suppes T et al. These issues include:You may need to have blood tests from time to time to check your blood sugar and cholesterol levels. Therefore, it is important that you tell your doctor as soon as possible if you notice anything that is making you feel unwell, even if you think the problems are not connected with this medicine. Fabre LF, Arvanitis L, Pultz J et al. Meats P. Quetiapine (’seroquel’); an effective and well-tolerated atypical antipsychotic. Preclinical profile of Seroquel (quetiapine): an atypical antipsychotic with clozapine-like pharmacology. Use a thin layer of Differin Gel once daily, all over your face – not just on acne spots. Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional.© 2004-2020 Healthline Media UK Ltd, Brighton, UK, a Red Ventures Company. The dosage may be increased at a slower rate, and a lower total daily dose may be used to lessen the risk of side effects.It hasn’t been confirmed that quetiapine is safe and effective to use for this purpose in children younger than 18 years.If you have stopped quetiapine for more than one week, you’ll need to be restarted at a lower dosage. Recent developments in the neuropharmacology of schizophrenia. This can help keep levels of this drug from building up too much in your body. Quetiapine is usually started with a low dose in order to allow the body to get used to it. It should not be used in children younger than 18 years.Your doctor may start you on a lowered dose or a different dosing schedule. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm154110.htm41. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Novartis Pharmaceuticals Corporation, East Hanover, NJ: Personal communication.85. In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used DIFFERIN® Cream once daily for 12 weeks. Food and Drug Administration. From the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm243903.htm.110. Food and Drug Administration. Rockville, MD; 2007 May 2. May contain hydrochloric acid to adjust pH. This can help keep levels of this drug from building up too much in your body. If you drink alcohol, talk to your doctor about whether this drug is safe for you.Talk to your doctor if you’re pregnant or planning to become pregnant. A comparison of five fixed doses of ’seroquel’ (ICI 204,636) with haloperidol and placebo in patients with schizophrenia. Your doctor will monitor your condition and may change your dose depending on how you respond to it. Keep warm in cool weather.Seroquel may affect the way your body reacts to temperature changes.Avoid drinking large quantities of grapefruit juice.This medicine may be affected by grapefruit juice. 70. 25. Please be aware that we do not give advice on your individual medical condition, if you want advice please see your treating physician. 90. Substantially higher mortality rate (4.5%) in geriatric patients with dementia-related psychosisMost fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).Antidepressants increased risk of suicidal thinking and behavior (suicidality) compared with placebo in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.Appropriately monitor and closely observe all patients who are started on quetiapine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.Management (alone or in combination with lithium or divalproex sodium) of acute manic episodes associated with bipolar I disorder.Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.Administer orally, generally 2–3 times daily without regard to meals.When switching from other antipsychotic agents to quetiapine, abrupt discontinuance of previous agent may be acceptable for some patients with schizophrenia, but gradual discontinuance may be appropriate for others.In patients being switched from long-acting (depot) parenteral antipsychotic therapy to oral quetiapine therapy, administer first oral dose in place of next scheduled depot injection of the long-acting preparation.Periodically reevaluate need for continuing any existing drug therapy for symptomatic relief of adverse extrapyramidal effects.Available as quetiapine fumarate; dosage is expressed in terms of quetiapine.Reinitiating therapy: In patients previously treated with quetiapine, dosage titration is not necessary if reinitiated after a drug-free period <1 week;Increase dosage in increments of 25–50 mg 2 or 3 times daily on the second or third day, as tolerated, to a target dosage of 300–400 mg daily in 2 or 3 divided doses by the fourth day.Make subsequent dosage adjustments at intervals of not less than 2 days, usually in increments or decrements of 25–50 mg twice daily.Dosages ranging from 150–750 mg daily were effective in clinical trials.Optimum duration of therapy currently not known, but efficacy of maintenance therapy with antipsychotics is well established.If discontinuance is considered, precautions include slow, gradual dose reduction over many months, more frequent clinician visits, and use of early intervention strategies.Optimum duration not established; efficacy has been demonstrated in two 12-week monotherapy trials and one 3-week adjunct therapy trial.Initially, 25 mg daily; increase dosage by 25–50 mg daily according to clinical response and tolerability until an effective dosage is reached.Consider a slower rate of dosage titration and a lower target dosage in geriatric patients and in patients who are debilitated or have a predisposition to hypotensive reactions.Initially, 25 mg twice daily to minimize risk of orthostatic hypotension and associated syncope.Known hypersensitivity to quetiapine or any ingredient in the formulation.Possible increased risk of death with use of atypical antipsychotics in geriatric patients with dementia-related psychosis.Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.Appropriately monitor and closely observe patients receiving quetiapine for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, reported rarely.Tardive dyskinesia, a syndrome of potentially irreversible, involuntary dyskinetic movements, reported infrequently.Severe hyperglycemia, sometimes associated with ketoacidosis, hyperosmolar coma, or death, reported in patients receiving atypical antipsychotic agents, including quetiapine.Possible lenticular changes; ophthalmologic examination of the lens by methods adequate to detect cataract formation (e.g., slit lamp exam) recommended at initiation of therapy, or shortly thereafter, and at 6-month intervals during chronic therapy.Possible risk of seizures; use with caution in patients with a history of seizures or with conditions known to lower the seizure threshold (e.g., dementia of the Alzheimer’s type, geriatric patients).Disruption of ability to reduce core body temperature possible; use with caution in patients exposed to conditions that may contribute to an elevation in core body temperature (e.g., dehydration, extreme heat, strenuous exercise, concomitant use of anticholinergic agents).Elevated prolactin concentrations reported with some atypical antipsychotic agents; not observed in clinical trials with quetiapine but reported in animals.Increases in cholesterol and triglyceride concentrations possible; weakly related to weight gain.Asymptomatic, transient, and reversible increases in serum transaminases (principally ALT) reported; usually occurred within first 3 weeks and resolved despite continued quetiapine therapy.Esophageal dysmotility and aspiration possible; use with caution in patients at risk for aspiration pneumonia (e.g., geriatric patients, those with advanced Alzheimer’s dementia).Ensure accuracy of prescription; similarity in spelling of Seroquel (quetiapine) and Serzone (former trade name for nefazodone hydrochloride, an antidepressant agent) may result in errors associated with adverse CNS (e.g., mental status deterioration, hallucination, paranoia, muscle weakness, lethargy, dizziness) and GI (e.g., nausea, vomiting, diarrhea) effects.Risk for extrapyramidal and/or withdrawal symptoms (e.g., agitation, hypertonia, hypotonia, tardive dyskinetic-like symptoms, tremor, somnolence, respiratory distress, feeding disorder) in neonates exposed to antipsychotic agents during the third trimester; monitor neonates exhibiting such symptoms.Distributes into human milk in relatively small amounts.Safety and efficacy not established in children <18 years of age.FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during the first few months of antidepressant treatment compared with placebo in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and other antidepressants).Carefully consider these findings when assessing potential benefits and risks of quetiapine in a child or adolescent for any clinical use.No substantial differences in safety relative to younger adults, but factors that decrease pharmacokinetic clearance, increase the pharmacodynamic response, or cause poorer tolerance or orthostasis may be present.Possible increased risk of death in geriatric patients with dementia-related psychosis.Increased plasma concentrations expected in patients with hepatic impairment; dosage adjustment may be necessary.Clearance may be decreased in severe renal impairment, but dosage adjustment not necessary.Somnolence, dizziness, dry mouth, constipation, increased ALT, weight gain, dyspepsia.Inhibitors or inducers of CYP3A4; potential pharmacokinetic interaction (altered quetiapine metabolism).Potentiation of cognitive and motor effects of alcoholAntifungals, azole (e.g., fluconazole, itraconazole, ketoconazole)Substantial decrease in quetiapine clearance with concomitant use of ketoconazole, resulting in increased peak plasma quetiapine concentrationsUse concomitantly with caution; dosage adjustment of quetiapine may be necessaryIncreased peak plasma quetiapine concentrations, with no effect on extent of absorption or mean quetiapine clearance; decreased peak plasma valproic acid concentrations and extent of absorption, but not significantRapidly absorbed after oral administration, with peak plasma concentrations attained within 1.5 hours.Extensively metabolized to inactive metabolites, principally via CYP3A4.Excreted in urine (73%) and feces (20%), with <1% of the drug excreted unchanged.In patients with hepatic impairment, clearance is 30% lower and AUC and peak plasma concentrations are 3 times higher than those of healthy individuals.In geriatric patients, clearance is decreased by about 40% compared with younger patients.Exact mechanism of antipsychotic action is not known; may involve antagonism at serotonin type 1 (5-hydroxytryptamine [5-HTImportance of providing written patient information (medication guide) each time quetiapine is dispensed.Importance of advising patients and caregivers that geriatric patients with dementia-related psychosis treated with antipsychotic agents are at an increased risk of death.Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.Risk of orthostatic hypotension, especially during initial dosage titration and at times of re-initiation of therapy or increases in dosage.Risk of somnolence and impairment of judgment, thinking, or motor skills; avoid driving, operating machinery, or performing hazardous tasks until effects on the individual are known.Importance of avoiding alcohol during quetiapine therapy.Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., diabetes mellitus, seizures, dementia).Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.Importance of informing patients of other important precautionary information.