Monograph Details
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Central Nervous System
> Psychosis
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CLOZARIL |
| Manufacturer |
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Novartis Pharmaceuticals Corp |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Atypical. |
| Generic Name |
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Clozapine 25mg, 100mg; scored tabs. |
| Indications |
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Refractory severe schizophrenia. To reduce risk of recurrent suicidal behavior in schizoaffective disorders. |
| Children |
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Not recommended. |
| Adults |
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Initially 12.5mg 1–2 times daily; then usually given in divided doses; may increase by 25–50mg/day to 300–450mg/day by the end of 2 weeks. Then may increase once or twice weekly in increments of up to 100mg; max 900mg/day. Reevaluate periodically. Reduce gradually over 1–2 weeks if discontinuing; may discontinue abruptly if necessary (eg, leukopenia, myocarditis; may cause relapse or cholinergic rebound). Retitrate if stopped for ≥2 days. Caution when rechallenging (see literature). Suicidal behavior: usually 300mg/day; range 12.5mg–900mg/day; treat for at least 2 years. |
| Contraindications |
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Concomitant bone marrow suppressants or other agranulocytosis-causing agents. Myeloproliferative disorders. Uncontrolled epilepsy. Severe or history of clozapine-induced agranulocytosis, granulocytopenia, or myocarditis. Paralytic ileus. CNS depression. Coma. Nursing mothers. |
| Precautions |
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See literature. Monitor WBC and absolute neutrophil count (ANC) at baseline, weekly for 1st 6 months and for 4 weeks after discontinuing; if acceptable WBC and ANC maintained, may reduce monitoring to every 2 weeks after 6 months, then every 4 weeks after 12 months. Monitor for myocarditis if tachycardia occurs in 1st month; discontinue if myocarditis suspected. Monitor for hyperglycemia. Diabetes or risk factors thereof. Seizures. Cardiovascular, pulmonary, renal, or hepatic disease; discontinued if jaundice or significant increases in liver enzymes occur. Glaucoma. GI or GU obstruction. Poor metabolizers. Surgery. Exclude infection, agranulocytosis, neuroleptic malignant syndrome if fever occurs. Elderly (not for dementia-related psychosis). Pregnancy (Cat.B). |
| Interactions |
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See Contraindications. Caution with general anesthetics, benzodiazepines, psychotropics (possible respiratory/cardiac arrest), fluvoxamine, paroxetine. May potentiate alcohol, CNS drugs, antihypertensives, anticholinergics. Caution with drugs that affect or are affected by CYP2D6, 3A4, 1A2; clozapine levels increased by CYP450 inhibitors (eg, citalopram, cimetidine, erythromycin); clozapine levels decreased by CYP450 inducers (eg, rifampin, phenytoin, nicotine). May potentiate or be potentiated by protein-bound drugs. Do not use epinephrine to reverse hypotension. |
| Adverse Reactions |
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Sedation, dizziness, salivation, anticholinergic toxicity (eg, GI paralysis), agranulocytosis, seizures, tachycardia, orthostatic hypotension, weight gain, hyperglycemia, fever, myocarditis, eosinophilia, CHF, neuroleptic malignant syndrome, thrombosis, pulmonary embolism. |
| Extra Text |
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Note: To register patients call National Registry at (800) 448-5938. |
| How Supplied |
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Tabs—100, 500 |
| Additional Resources |
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• Related Prescribing Note |
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