Clozapine Orally-disintegrating Tabs

See full labeling. Risk of severe neutropenia; obtain CBC and confirm baseline ANC ≥1500/μL (≥1000/μL if benign ethnic neutropenia) prior to initiation. Monitor WBC and ANC weekly for 1^st 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. Increased mortality in elderly with dementia-related psychosis (not approved use). Cardio- or cerebrovascular disease. Conditions that would predispose to hypotension (eg, concomitant antihypertensives, dehydration, hypovolemia). Perform fall risk assessments when initiating and recurrently on long-term therapy. History of or risk factors for seizure. Monitor for myocarditis or cardiomyopathy; discontinue if suspected. Increased risk of QT prolongation; discontinue if interval >500msec. Significant cardiac arrhythmia. Recent MI. Uncompensated heart failure. Consider obtaining baseline ECG and serum chemistry panel. Correct electrolyte abnormalities prior to starting; obtain baseline serum potassium and magnesium levels; monitor periodically thereafter. Monitor for hyperglycemia. Diabetes or risk factors thereof. Monitor for hepatotoxicity; consider permanently discontinuing if clozapine-associated hepatitis or elevated transaminases occur. Exclude severe neutropenia, infection, neuroleptic malignant syndrome if fever occurs. Narrow-angle glaucoma. Constipation (screen and treat prior to initiation). Urinary retention. Significant prostatic hypertrophy. Renal or hepatic impairment. CYP2D6 poor metabolizers. Use lowest effective dose for shortest duration. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3^rd-trimester pregnancy). Pregnancy (Cat.B). Nursing mothers: not recommended.