How should I store my medication? Check with your doctor right away if you have increased thirst or urination. If you have diabetes, the results of your urine or blood sugar tests may change. Check your blood sugar closely and talk with your doctor if you have any questions. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups. Dunican and Deltotto, 2007.
One case, involving an estimated overdose of 9600 mg, was associated with hypokalemia and first-degree heart block. In post-marketing experience, there were cases reported of QT prolongation with overdose. See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions. This Medication Guide summarizes the most important information about Quetiapine Fumarate Extended-Release Tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Quetiapine Fumarate Extended-Release Tablets that is written for health professionals.
Based on weight of evidence quetiapine was not mutagenic or clastogenic in these tests. Antagonism at receptors other than dopamine and serotonin with similar or greater affinities may explain some of the other effects of quetiapine and norquetiapine: antagonism at histamine H 1 receptors may explain the somnolence, antagonism at adrenergic α 1b receptors may explain the orthostatic hypotension, and antagonism at muscarinic M 1 receptors may explain the anticholinergic effects. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking quetiapine.
Quetiapine Fumarate Extended-Release Tablets in the bipolar mania trial. Quetiapine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance or physical dependence. In general, the adverse reactions observed in children and adolescents during the clinical trials with Quetiapine Fumarate Immediate-Release Tablets were similar to those in the adult population with few exceptions. Increases in systolic and diastolic blood pressure occurred in children and adolescents and did not occur in adults.
This medication may increase this risk of thoughts or behavior in children, teens, and young adults. Children who use this medication may experience an increase in blood pressure. Review and case reports. The following adverse reactions were identified during post approval use of Quetiapine Fumarate Immediate-Release Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. There are no adequate and well-controlled studies of Quetiapine Fumarate Extended-Release Tablets use in pregnant women. In limited published literature, there were no major malformations associated with quetiapine exposure during pregnancy. In animal studies, embryo-fetal toxicity occurred. Quetiapine Fumarate Extended-Release Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. See Boxed Warning and also see Pediatric Use under Cautions. Block G. Dear healthcare professional letter: dispensing errors alert. Atypical antipsychotics are not approved for the treatment of dementia-related psychosis. a 97 98 See Boxed Warning and see Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions. The dose of quetiapine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of quetiapine.
Importance of avoiding alcohol during quetiapine therapy. Based on response and tolerability, may be administered three times daily. Davidson M, Galderisi S, Weiser M, et al. "Cognitive Effects of Antipsychotic Drugs in First-Episode Schizophrenia and Schizophreniform Disorder: A Randomized, Open-Label Clinical Trial EUFEST. Lewis-Hall F. Dear health care professional letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. Princeton, NJ: Briston-Myers Squibb Company; 2004 Mar 25. From FDA website. Patients should be advised to report to their physician any signs or symptoms that may be related to NMS. Upper respiratory tract infection 7%; cough 3%; dyspnea at least 1%.
Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done. Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, 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. Such monitoring should include daily observation by families and caregivers. Prescriptions for quetiapine should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. Coma, death, drowsiness, first-degree heart block, hypokalemia, hypotension, QTc prolongation, sedation, tachycardia. Like other drugs that antagonize dopamine D 2 receptors, quetiapine elevates prolactin levels in some patients and the elevation may persist during chronic administration. Hyperprolactinemia, regardless of etiology, may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotrophin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects. Quetiapine may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision especially during the first week of use which may lead to falls, fractures or other injuries. Make sure you know how you react to quetiapine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well. Take quetiapine tablets exactly as your healthcare provider tells you to take it. Do not change the dose yourself. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment. Lin GL, Chiu CH, Lin SK "Quetiapine-induced Erythema Multiforme Minor: A Case Report. Several instruments were used for assessing psychiatric signs and symptoms in these studies, among them the Brief Psychiatric Rating Scale BPRS a multi-item inventory of general psychopathology traditionally used to evaluate the effects of drug treatment in schizophrenia. The BPRS psychosis cluster conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content is considered a particularly useful subset for assessing actively psychotic schizophrenic patients. A second traditional assessment, the Clinical Global Impression CGI reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient. Food and Drug Administration. Revisions to medication guide: antidepressant medicines, depression and other serious mental illnesses and suicidal thoughts or actions. Rockville, MD; 2007 May 2. From the FDA web site. Instruct patient to avoid alcoholic beverages while taking quetiapine. Low levels of or in the blood may also increase your risk of QT prolongation. Coadministration of ketoconazole, a potent inhibitor of cytochrome CYP3A4, resulted in significant increase in quetiapine exposure.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor. Mahmoud RA. Dear health care professional letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. Titusville, NJ: Janssen Pharmaceutica, Inc; 2004. From the FDA website. Quetiapine Fumarate Immediate-Release Tablets 600 mg compared to 0% of patients receiving placebo. Eli Lilly and Company, Indianapolis, IN: Personal communication. Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. Quetiapine Fumarate Extended-Release Tablets and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. Cavazzoni P, Mukhopadhyay N, Carlson C et al. Retrospective analysis of risk factors in patients with treatment-emergent diabetes during clinical trials of antipsychotic medications. Br J Psychiatry Suppl. No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
When treating pediatric patients with Quetiapine Fumarate Immediate-Release Tablets for any indication, weight gain should be assessed against that expected for normal growth. Antipsychotics can disrupt the body's ability to reduce core temperature. It may harm them. QT intervals have not been systematically evaluated. During clinical trials, persistent increases in QT intervals were not identified; however there have been postmarketing reports of QT prolongation in patients who overdosed on this drug, in patients with concomitant illness, and in patients taking drugs that are known to cause electrolyte imbalance or QT interval prolongation. Leucht S, Wahlbeck K, Hamann J et al. New generation antipsychotics versus low-potency conventional antipsychotics: a systematic review and meta-analysis. Lancet. 2003; 361: 1581-89. Lens changes have also been observed in adults, children, and adolescents during long-term quetiapine treatment but a causal relationship to quetiapine use has not been established. Nevertheless, the possibility of lenticular changes cannot be excluded at this time. Therefore, examination of the lens by methods adequate to detect cataract formation, such as slit lamp exam or other appropriately sensitive methods, is recommended at initiation of treatment or shortly thereafter, and at 6-month intervals during chronic treatment. Hypersensitivity to quetiapine or to any excipients in the quetiapine formulation. Anaphylactic reactions have been reported in patients treated with quetiapine. Etminan M, Streiner DL, Rochon PA. Exploring the association between atypical neuroleptic agents and diabetes mellitus in older adults. Pharmacotherapy. Bushe C, Leonard B. Association between atypical antipsychotic agents and type 2 diabetes: review of prospective clinical data. Br J Psychiatry Suppl. In adults, dose-related decreases in thyroid hormone levels have been observed. It appears that maximal reductions in total and free thyroxine T4 occur in the first 6 weeks of treatment and are maintained without adaptation or progression during chronic therapy. Upon therapy discontinuation, these effects mostly return to baseline values. The mechanism by which this drug affects the thyroid axis is unclear. Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Quetiapine Fumarate Immediate-Release Tablets.
Rare: aphasia, buccoglossal syndrome, choreoathetosis, delirium, emotional lability, euphoria, libido decreased 2, neuralgia, stuttering, subdural hematoma. DSM-IV criteria for bipolar I disorder studies 9 and 10. The trials included patients whose most recent episode was manic, depressed, or mixed, with or without psychotic features. In the open-label phase, patients were required to be stable on Quetiapine Fumarate Immediate-Release Tablets plus lithium or divalproex for at least 12 weeks in order to be randomized. On average, patients were stabilized for 15 weeks. Tell patient to immediately report altered mental status, high fever, irregular or fast pulse, muscle rigidity, rash, seizures, or sweating to health care provider. Other medications can affect the removal of quetiapine from your body, which may affect how quetiapine works. If signs and symptoms of tardive dyskinesia appear in a patient on quetiapine, drug discontinuation should be considered. However, some patients may require treatment with quetiapine despite the presence of the syndrome. Quetiapine Fumarate Extended-Release Tablets are indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. Logistic regression analysis has shown a positive dose response for dyspepsia and abdominal pain. The mean HAM-D total score at entry was 24, and 17% of patients scored 28 or greater. CNS depressants medicines that make you drowsy or less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using quetiapine. For the acute treatment of manic or mixed episodes associated with bipolar I disorder. Mood stabilizer: lithium or divalproex; SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: unadjusted confidence interval.
Doses that are statistically significant superior to quetiapine 50 mg BID. Table 8 shows the incidence of these shifts in short-term placebo-controlled clinical trials. This is not a complete list of possible side effects. In the acute therapy of schizophrenia up to 6 weeks and bipolar mania up to 12 weeks trials, the most commonly observed adverse reactions associated with the use of quetiapine monotherapy incidence of 5% or greater and observed at a rate on quetiapine at least twice that of placebo were somnolence 18% dizziness 11% dry mouth 9% constipation 8% ALT increased 5% weight gain 5% and dyspepsia 5%. In clinical trials, survival has been reported in acute overdoses of up to 30 grams of quetiapine. Therefore, both TSH and free T 4, in addition to clinical assessment, should be measured at baseline and at follow-up. Follow all directions on your prescription label. Never take quetiapine in larger amounts, or for longer than recommended by your doctor. High doses or long-term use of quetiapine can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include tremors or other uncontrollable muscle movements. This medication may rarely cause a very serious condition called NMS. Somnolence usually occurred during the first 2 weeks and resolved with continued therapy. Quetiapine Fumarate Immediate-Release Tablets for the treatment of acute bipolar mania. In clinical trials with quetiapine the following increases in weight have been reported.
Citrome L, Jaffe A, Levine J et al. Relationship between antipsychotic medication treatment and new cases of diabetes among psychiatric inpatients. Psychiatr Serv. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Very common 10% or more: Systolic 15. Dosage adjustment may be needed. The potential effects of several concomitant medications on quetiapine pharmacokinetics were studied. What is a depressive disorder? Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents. Serum measurements in a 1-year toxicity study showed that quetiapine increased median serum prolactin levels a maximum of 32-and 13-fold in male and female rats, respectively. Increases in mammary neoplasms have been found in rodents after chronic administration of other antipsychotic drugs and are considered to be prolactin-mediated. You will need to have your blood pressure measured before starting quetiapine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. In 2 of the 8 hepatically impaired patients, AUC and C max were 3 times higher than those observed typically in healthy subjects. Citrome LL. Efficacy should drive atypical antipsychotic treatment. BMJ. 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.
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For patients who have been off this drug for less than 1 week, gradual dose titration may not be needed and the maintenance dose may be reinitiated. Of the quetiapine treated patients with elevated TSH levels, 1 had simultaneous low free T 4 level at end of treatment. Quetiapine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.
AstraZeneca Pharmaceuticals LP. Seroquel quetiapine fumarate tablets prescribing information. Wilmington, DE; 2011 Jul. If you plan to get dental work or surgery done, you should let your dentist or surgeon know you are taking this drug. 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. Drink plenty of water. ER C max and AUC. In comparison, a light meal had no effect on the C max or AUC of quetiapine. It is recommended that quetiapine ER be taken without food or with a light meal.
Dyslipidemia: Across indications, adult patients who experienced shifts in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline to clinically significant levels occurred in up to 18%, 22%, 6%, and 14% of patients receiving this drug compared with up to 7%, 16%, 5%, and 14% receiving placebo, respectively. For pediatric patients, the shifts were up to 12%, 22%, 8%, and 15% compared to up to 3%, 13%, 5%, and 19% for this drug and placebo, respectively. Importance of avoiding overheating or dehydration. The management of NMS should include: 1 immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2 intensive symptomatic treatment and medical monitoring; and 3 treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for NMS.
Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime. Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 103 109 Importance of clinicians informing patients about the benefits and risks of taking antipsychotics during pregnancy see Pregnancy under Cautions. 103 109 Importance of advising patients not to stop taking quetiapine if they become pregnant without consulting their clinician; abruptly discontinuing antipsychotic agents may cause complications. 109 Importance of advising patients not to breast-feed during therapy.