Dosing was flexible, with a dose range of 200–900 mg/day for Clozaril and 5–20 mg/day for olanzapine. Sixty-two percent of the patients were diagnosed with schizophrenia, and the remainder (38%) were diagnosed with schizoaffective disorder. Clozapine lowers the seizure threshold in a dose-dependent manner and thus may induce seizures; dosage adjustments of clozapine should be cautious. If eosinophilia develops during Clozaril 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. A literature review of available evidence, using the keywords clozapine and chemotherapy, was completed using Medline and a cross-database search. Approximately 88% of patients from the Clozaril and chlorpromazine groups completed the 6-week trial. In a pooled data analysis of 2 studies in adult subjects with schizophrenia, Clozaril treatment was associated with increases in fasting serum triglyceride. Discontinue Clozaril and obtain a cardiac evaluation upon suspicion of myocarditis or cardiomyopathy. BEN is more common in men. Clinical monitoring, including baseline and periodic follow-up lipid evaluations in patients using Clozaril, is recommended.In a pooled data analysis of 10 studies in adult subjects with schizophrenia, Clozaril treatment was associated with increases in serum total cholesterol. You may need frequent medical tests while using this medicine and for a short time after your last dose.You should not stop using clozapine suddenly. In patients with suspected cardiomyopathy, consider a 2D-echo Doppler examination to identify mitral valve incompetence.Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Consider hematology consultation before initiating or during Clozaril treatment as necessary.Patients with BEN require a different ANC algorithm for Clozaril management due to their lower baseline ANC levels. 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. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Whether pulmonary embolus and deep-vein thrombosis can be attributed to clozapine or some characteristic(s) of patients is not clear.Clozaril can cause sedation and impairment of cognitive and motor performance. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality in this population. 5. 3. In general, however, do not rechallenge patients who develop severe neutropenia with Clozaril or a clozapine product.If a patient will be rechallenged, the clinician should consider thresholds provided in It is unclear if concurrent use of other drugs known to cause neutropenia increases the risk or severity of Clozaril-induced neutropenia. Use Clozaril cautiously in patients with cardiovascular or cerebrovascular disease or conditions predisposing to hypotension (e.g., dehydration, use of antihypertensive medications)Seizures have occurred with Clozaril treatment. On the 18-item BPRS, 1 indicates the absence of symptoms, and 7 indicates severe symptoms; the maximum potential total BPRS score is 126. Avoid any activity that could be dangerous if you have a seizure or lose consciousness.uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);Untreated constipation may lead to serious bowel complications, hospitalization, or death. Monitor closely if restarting treatment with antipsychotics.NMS has occurred with Clozaril monotherapy and with concomitant CNS-active medications, including lithium.Severe, life threatening, and in some cases fatal hepatotoxicity including hepatic failure, hepatic necrosis, and hepatitis have been reported in post marketing studies in patients treated with clozapine During clozapine therapy, patients have experienced transient, clozapine-related fever. The maximum daily Clozaril dose was 900 mg; the mean daily dose was >600 mg. Strong CYP3A4 inducers include carbamazepine, phenytoin, St. John’s wort, and rifampin. You may report side effects to FDA at 1-800-FDA-1088.When you start or stop taking Clozaril, your doctor may need to adjust the doses of any other medicines you take on a regular basis.Many drugs can interact with clozapine. The maximum dose is 900 mg per day. Because of the potential for serious adverse reactions in nursing infants from Clozaril, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.Safety and effectiveness in pediatric patients have not been established.There have not been sufficient numbers of geriatric patients in clinical studies utilizing Clozaril to determine whether those over 65 years of age differ from younger subjects in their response to Clozaril.Orthostatic hypotension and tachycardia can occur with Clozaril treatment Elderly patients may be particularly susceptible to the anticholinergic effects of Clozaril, such as urinary retention and constipation Carefully select Clozaril doses in elderly patients, taking into consideration their greater frequency of decreased hepatic, renal, or cardiac function, as well as other concomitant disease and other drug therapy. These reactions can be fatal. Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that Clozaril does not affect them adversely.
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