| TAH Drug Code | OMEZ |
|---|---|
| Indications | Schizophrenia, treatment resistant: Treatment of severely ill patients with schizophrenia who fail to respond adequately to antipsychotic treatment. Suicidal behavior in schizophrenia or schizoaffective disorder: To reduce the risk of suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for reexperiencing suicidal behavior, based on history and recent clinical state. |
| Dosing | Schizophrenia: Oral: Initial: 12.5 mg once or twice daily; increase, as tolerated, in increments of 25 to 50 mg daily to a target dose of 300 to 450 mg daily (administered in divided doses) by the end of 2 weeks; may further titrate in increments not exceeding 100 mg and no more frequently than once or twice weekly. Maximum total daily dose: 900 mg. Suicidal behavior in schizophrenia or schizoaffective disorder: Oral: Initial: 12.5 mg once or twice daily; increased, as tolerated, in increments of 25 to 50 mg daily to a target dose of 300 to 450 mg daily (administered in divided doses) by the end of 2 weeks; may further titrate in increments not exceeding 100 mg and no more frequently than once or twice weekly. Mean dose is ~300 mg daily; maximum total daily dose: 900 mg. |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment not necessary |
| Contraindications | Serious hypersensitivity to clozapine or any component of the formulation (eg, photosensitivity, vasculitis, erythema multiforme, or Stevens-Johnson syndrome [SJS]) |
| Adverse Effects | Initially drowsiness, hypersalivation, granulocytopenia & agranulocytosis, palpitation, fatigue. Dry mouth, blurred vision, orthostatic hypotension, disturbance in temp regulation. Tachycardia, ECG changes. Rarely: delirium, extrapyramidal reactions. Cardiovascular: Hypotension, Tachyarrhythmia (25%) Dermatologic: Rash (2%), Sweating symptom (6%) Endocrine metabolic: Excessive salivation (31% ), Weight gain (4%) Gastrointestinal: Constipation (14% ), Excessive salivation (31% ), Nausea (5% ), Xerostomia (6% ) Musculoskeletal: Motor function behavior finding (4%), Muscle rigidity (3%) Neurologic: Akathisia (3%), Confusion (3%), Dizziness (19%), Headache (7%), Insomnia (2%), Somnolence (39%), Tremor (6%), Vertigo (19%) Ophthalmic: Visual disturbance (5%) Psychiatric: Agitation (4%), Dyssomnia, Nightmares (4%), Restlessness (4%) Other: Fatigue (2%), Fever (5%) Tachycardia, ECG changes. Rarely: delirium, extrapyramidal reactions. |
| Pregnancy | Compatible – Maternal Benefit >> Embryo-Fetal Risk |
| Lactation | No (Limited) Human Data - Potential Toxicity |
| More Info | UpToDate |