chronic administration; hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion; this, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (elderly patients, patients with dehydration, hypovolemia, concomitant treatment with antihypertensive medications May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy 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) QT interval prolongation Not associated with persistent increase in QT interval in trials, but QT effect was not systematically evaluated in thorough study QT prolongation reported with acute overdose during postmarketing experience Avoid using in combination with other drugs known to prolong QTc or in patients with increased risk of QT prolongation Pregnancy There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine, during pregnancy; healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry Neonates exposed during third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery; overall available data from published epidemiologic studies of pregnant women exposed to drug have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to the mother associated with untreated schizophrenia, bipolar I, or major depressive disorder, and with exposure to drug during pregnancy There is a risk to the mother from untreated schizophrenia, or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide; schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth; it is not known if this is a direct result of the illness or other comorbid factors Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder reported in neonates exposed to drug, during third trimester of pregnancy; symptoms varied in severity; monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately; some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization Based on pharmacologic action of drug, treatment may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential Animal data In animal studies, embryo-fetal toxicity occurred including delays in skeletal ossification at approximately 1 and 2 times maximum recommended human dose (MRHD) of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD; in addition, fetal weights were decreased in both species; maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and approximately 1-2 times the MRHD in rabbits Lactation Limited data from published literature report the presence of drug in human breast milk at relative infant dose of <1% of maternal weight-adjusted dosage; there are no consistent adverse events reported in infants exposed to quetiapine through breast milk; there is no information on effects of quetiapine on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from mother’s underlying conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action 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 Absorption Bioavailability: 100% (oral solution) Peak plasma time: Immediate release, 1.5 hr; extended release, 6 hr Distribution Protein bound: 83% Vd: 6-14 L/kg Metabolism Metabolized in liver by CYP3A4 Elimination Half-life: Immediate release, 6 hr; extended release, 7 hr Excretion: Urine (73%), feces (20%) BRAND FORM. UNIT PRICE PILL IMAGE quetiapine oral- 50 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 150 mg tabletquetiapine oral- 25 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 25 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 25 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 25 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 25 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 150 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 25 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 25 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 150 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 25 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 25 mg tabletquetiapine oral- 25 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 100 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 150 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 150 mg tabletquetiapine oral- 50 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 150 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 400 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 200 mg tabletquetiapine oral- 300 mg tabletquetiapine oral- 400 mg tabletSeroquel oral- 25 mg tabletSeroquel oral- 50 mg tabletSeroquel oral- 300 mg tabletSeroquel oral- 200 mg tabletSeroquel oral- 100 mg tabletSeroquel oral- 400 mg tabletSeroquel XR oral- 300 mg tabletSeroquel XR oral- 200 mg tabletSeroquel XR oral- 400 mg tabletSeroquel XR oral- 150 mg tabletSeroquel XR oral- 50 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationquetiapine oral QUETIAPINE SUSTAINED-RELEASE - ORAL (kweh-TIE-ah-peen) COMMON BRAND NAME(S): Seroquel XR WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.If you are using quetiapine in combination with other medication to treat depression, also carefully read the drug information for the other medication.Quetiapine sustained-release is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder). It is also used with other medications to treat depression. Drugs used to treat depression can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take drugs to treat depression may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of drugs used to treat depression (especially for people younger than 25), even if treatment is not for a mental/mood condition.Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new drug to treat depression is started or when the dose is changed.This medication is not approved for use in children under 10 years old. USES: This medication is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder). It is also used with other medications to treat depression. Quetiapine is known as an anti-psychotic drug (atypical type). It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain.This medication can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. It may also improve your mood, sleep, appetite, and energy level. Quetiapine can help prevent severe mood swings or decrease how often mood swings occur. HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using quetiapine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually once daily in the evening without food or with a light meal. Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as trouble sleeping, nausea, headache, diarrhea, irritability. Your dose may need to be gradually decreased to reduce side effects. Report any new or worsening symptoms right away.Tell your doctor if your condition lasts or gets worse. SIDE EFFECTS: See also Warning section.Constipation, drowsiness, upset stomach, tiredness, weight gain, blurred vision, or dry mouth may occur. If any of these effects last or get worse, tell your doctor promptly.Dizziness or lightheadedness may occur, especially when you first start or increase your dose of this drug. Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, constipation with abdominal pain that doesn't go