During treatment, patients must have regular ANC monitoring. Patients in the general population with an ANC equal to or greater than (≥)1500/µL are considered within normal range (Benign ethnic neutropenia (BEN) is a condition observed in certain ethnic groups whose average ANC values are lower than “standard” laboratory ranges for neutrophils. Chest roentgenogram may demonstrate cardiac silhouette enlargement, and cardiac imaging (echocardiogram, radionucleotide studies, or cardiac catheterization) may reveal evidence of left ventricular dysfunction. This result should be interpreted only as evidence of the effectiveness of Clozapine in delaying time to recurrent suicidal behavior and not a demonstration of the superior efficacy of Clozapine over olanzapine.The probability of experiencing (1) a significant suicide attempt, including a completed suicide, or (2) hospitalization because of imminent suicide risk, including increased level of surveillance for suicidality for patients already hospitalized, was lower for Clozapine patients than for olanzapine patients at Week 104: Clozapine 24% versus olanzapine 32%; 95% CI of the difference: 2%, 14% (Clozapine tablets are available as 25 mg, 50 mg, and 100 mg round, pale-yellow, uncoated tablets with a facilitated score on one side. These reactions can occur with the first dose, with doses as low as 12.5 mg per day. Use caution when administering Clozapine concomitantly with drugs that are inducers or inhibitors of these enzymes.Concomitant use of Clozapine and CYP1A2 inhibitors can increase plasma levels of Clozapine, potentially resulting in adverse reactions. Individual treatment decisions should weigh the importance of monitoring ANC in the context of the need to control psychiatric symptoms and the patient’s terminal illness.The most commonly reported signs and symptoms associated with Clozapine overdose are: sedation, delirium, coma, tachycardia, hypotension, respiratory depression or failure; and hypersalivation. There is no general agreement about specific pharmacological treatments for NMS.If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The following adverse reactions have been identified during post-approval use of Clozapine. 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.Delirium, EEG abnormal, myoclonus, paresthesia, possible cataplexy, status epilepticus, obsessive compulsive symptoms, and post-discontinuation cholinergic rebound adverse reactions.Atrial or ventricular fibrillation, ventricular tachycardia, palpitations, QT interval prolongation, Torsades de Pointes, mitral valve incompetence associated with Clozapine-related cardiomyopathy, myocardial infarction, cardiac arrest, and periorbital edema.Acute pancreatitis, dysphagia, salivary gland swelling, colitis, megacolon, intestinal ischemia or infarction.Cholestasis, hepatitis, jaundice, hepatotoxicity, hepatic steatosis, hepatic necrosis, hepatic fibrosis, hepatic cirrhosis, liver injury (hepatic, cholestatic, and mixed), and liver failure.Acute interstitial nephritis, nocturnal enuresis, priapism, renal failure, and retrograde ejaculation.Hypersensitivity reactions: photosensitivity, vasculitis, erythema multiforme, skin pigmentation disorder, and Stevens-Johnson Syndrome.Myasthenic syndrome, rhabdomyolysis, and systemic lupus erythematosus.Aspiration, pleural effusion, pneumonia, lower respiratory tract infection, sleep apnea.Mild, moderate, or severe leukopenia, agranulocytosis, granulocytopenia, WBC decreased, deep-vein thrombosis, elevated hemoglobin/hematocrit, erythrocyte sedimentation rate (ESR) increased, sepsis, thrombocytosis, and thrombocytopenia.Creatine phosphokinase elevation, hyperuricemia, hyponatremia, and weight loss.Clozapine is a substrate for many cytochrome P450 isozymes, in particular CYP1A2, CYP3A4, and CYP2D6. The mean increase in total cholesterol was 13 mg/dL in the Clozapine group and 15 mg/dL in the chlorpromazine group. No data were collected on LDL and HDL cholesterol. Patients must have had a Clinical Global Impressions–Severity Scale score of at least 4 (moderately ill).In the prospective, lead-in phase of the trial, all patients (N=305) initially received single-blind treatment with haloperidol (the mean dose was 61 mg per day) for 6 weeks. Typical laboratory findings include elevated troponin I or T, elevated creatinine kinase-MB, peripheral eosinophilia, and elevated C-reactive protein (CRP). If eosinophilia develops during Clozapine treatment, evaluate promptly for signs and symptoms of systemic reactions, such as rash or other allergic symptoms, myocarditis, or other organ-specific disease associated with eosinophilia. WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSISClozapine treatment has caused severe neutropenia, defined as an absolute neutrophil count (ANC) less than 500/µL.
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