the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn; antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process The effect that symptomatic suppression has upon long-term course of the syndrome is unknown; given these considerations, this treatment should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia; chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that is known to respond to antipsychotic drugs, and for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate In patients who do require chronic treatment, the smallest dose and shortest duration of treatment producing a satisfactory clinical response should be sought; the need for continued treatment should be reassessed periodically; if signs and symptoms of tardive dyskinesia appear in a patient on therapy, drug discontinuation should be considered; however, some patients may require treatment with despite the presence of the syndrome Neuroleptic malignant syndrome A potentially fatal symptom complex sometimes referred to as neuroleptic malignant syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including this medication; clinical manifestations include hyperpyrexia, muscle rigidity, altered mental status (including catatonic signs) and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia); additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure The diagnostic evaluation of patients with this syndrome is complicated; in arriving at a diagnosis, it is important to identify cases in which the clinical presentation includes both serious medical illness (eg, pneumonia, systemic infection, etc) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS) Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology The management of this syndrome should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and 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; if a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered; the patient should be carefully monitored since recurrences of NMS have been reported QT Prolongation Prolongs QT interval; caution with other drugs/conditions that increase QTc; use of this medication should be avoided in combination with other drugs that are known to prolong QTc including Class 1A (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (eg, chlorpromazine, thioridazine), antibiotics (eg, gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval (e.g., pentamidine, levomethadyl acetate, methadone) Therapy should also be avoided in patients with known genetic susceptibility to congenital long QT syndrome and in patients with a history of cardiac arrhythmias; certain circumstances may increase risk of torsade de pointes and/or sudden death in association with use of drugs that prolong the QTc interval, including bradycardia, hypokalemia, or hypomagnesemia, concomitant use of other drugs that prolong QTc interval and presence of congenital prolongation of the QT interval, recent acute myocardial infarction; and/or uncompensated heart failure Caution is warranted when prescribing this medication with drugs that inhibit its metabolism, and in patients with reduced activity of CYP2D6 It is recommended that patients being considered for treatment who are at risk for significant electrolyte disturbances have baseline serum potassium and magnesium measurements with periodic monitoring; hypokalemia (and/or hypomagnesemia) may increase risk of QT prolongation and arrhythmia Therapy should be avoided in patients with histories of significant cardiovascular illness, eg, QT prolongation, recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia Therapy should be discontinued in patients who are found to have persistent QTc measurements >500 msec; if patients taking this medication experience symptoms that could indicate the occurrence of cardiac arrhythmias, eg, dizziness, palpitations, or syncope, the prescriber should initiate further evaluation, including cardiac monitoring Pregnancy There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this medication during pregnancy; for more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ Neonates whose mothers are exposed to antipsychotic drugs during third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery The limited available in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates whose mothers were exposed to antipsychotic drugs during third trimester of pregnancy These symptoms have varied in severity; some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization; monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately Animal data This drug was not teratogenic when administered orally to pregnant rats during organogenesis at doses up to 26 times maximum recommended human dose of 24 mg/day on mg/m2 basis; however, it prolonged the duration of pregnancy and parturition, increased stillbirths, early intrauterine deaths, increased incidence of developmental delays, and decreased post-partum pup survival The drug was not teratogenic when administered orally to pregnant rabbits during organogenesis at doses up to 20-times the MRHD on mg/m2 basis; however, it increased early intrauterine deaths and decreased fetal viability at term at highest dose which was also a maternally toxic dose Lactation There is no information regarding presence of iloperidone or metabolites in human milk, effects on a breastfed child, or on human milk production; the drug is present in rat milk; because of potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during therapy The transfer of radioactivity into milk of lactating rats was investigated following a single dose of 5 mg/kg; the concentration of radioactivity in milk at 4 hr post-dose was near 10-fold greater than that in plasma at same time; however, by 24 hours after dosing, concentrations of radioactivity in milk had fallen to values slightly lower than plasma; the metabolic profile in milk was qualitatively similar to that in plasmaPregnancy 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 May act by antagonizing a combination of dopamine type 2 (D2) and serotonin type 2 (5-HT2) receptors. Alpha blocker Absorption Bioavailability 96% Peak Plasma Time: 2-4 hr Distribution Protein Bound: 95% Vd: 1340-2800 L Metabolism Metabolized by CYP2D6 and CYP3A4 Elimination Excretion: Urine (45-58%), feces (20-22%) BRAND FORM. UNIT PRICE PILL IMAGE Fanapt oral- 6 mg tabletFanapt oral- 2 mg tabletFanapt oral- 1 mg tabletFanapt oral- 4 mg tabletFanapt oral- 1mg(2)-2mg(2)- 4mg(2)-6mg(2) tabletFanapt oral- 8 mg tabletFanapt oral- 12 mg tabletFanapt oral- 10 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationiloperidone oral ILOPERIDONE - ORAL (EYE-loe-PER-i-done) COMMON BRAND NAME(S): Fanapt 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 iloperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication. USES: This medication is used to treat certain mental/mood disorders (such as schizophrenia). Iloperidone helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). Iloperidone is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain. HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 2 times a day. Dosage is based on your medical condition, other drugs you are taking, and your response to treatment.To reduce your risk of side effects from low blood pressure (such as dizziness, fainting, fast heartbeat), your doctor will start you on a low dose and gradually increase your dose until you are taking the best dose for you. It may take 1 to 2 weeks before you are taking your full dose. Follow your doctor's directions carefully.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. If you miss or stop taking this medication for more than 3 days, do not restart taking this medication at the same dose without calling your doctor first. Your doctor may direct you to restart at a low dose and gradually increase the dose.Continue taking this medication exactly as prescribed, even if you are feeling better and thinking more clearly. Do not increase your dose or take this drug more often than prescribed. Your symptoms will not improve any faster, and your risk of side effects will increase. Do not stop taking this medication without consulting your doctor.Tell your doctor if your condition does not improve or if it worsens. It may take several weeks before you feel the full benefit of this medication. SIDE EFFECTS: See also How to Use section.Drowsiness, dizziness, lightheadedness, dry mouth, tiredness, stuffy nose, and weight gain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.This medication may cause a serious drop in blood pressure, especially when starting or increasing the dose. 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: drooling/trouble swallowing, signs of infection (such as cough that doesn't go away, fever), shaking (tremor), muscle spasms, interrupted breathing during sleep.Rarely, this medication may cause face/muscle twitching and uncontrollable movements (tardive dyskinesia). In some cases, this condition may be permanent. Tell your doctor right away if you develop any uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, chewing, or unusual arm/leg movements.This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. Weight gain from this drug may increase the risk of this side effect. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.In rare cases, iloperidone may increase your level of a certain substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.Get medical help right away if you have any very serious side effects, including: fainting, fast/irregular heartbeat, seizures, severe dizziness, chest pain.This medication may rarely