Mylan Healthcare


Concise Prescribing Info
Patients w/ schizophrenia who are non-responsive to or intolerant of classic antipsychotics. Recurrent suicidal behaviour in patients w/ schizophrenia or schizoaffective disorders.
Dosage/Direction for Use
Schizophrenia & recurrent suicidal behavior 12.5 mg (½ of 25 mg tab) once or bd on 1st day, 25 or 50 mg on 2nd day, may be increased up to 300-450 mg daily in divided doses. Max: 900 mg daily. Patient w/ CV disorder or mild to moderate renal impairment Initially 12.5 once daily on 1st day, increase slowly & in small increments; ≥60 yr Initially 12.5 mg once daily on 1st day w/ subsequent dose increments restricted to 25 mg daily.
May be taken with or without food.
Hypersensitivity. Patients unable to undergo regular blood tests; history of toxic or idiosyncratic granulocytopenia/agranulocytosis (except due to previous chemotherapy); impaired bone marrow function; uncontrolled epilepsy; alcoholic & other toxic psychoses, drug intoxication, comatose conditions; circulatory collapse; CNS depression; severe renal or cardiac disorders; active liver disease associated w/ nausea, anorexia or jaundice; progressive liver disease, hepatic failure; paralytic ileus.
Special Precautions
Patients w/ treatment-resistant schizophrenia, w/ schizophrenia or schizoaffective disorder who are at risk for recurrent suicidal behaviour. Development of agranulocytosis, eosinophilia or thrombocytopenia. CV disorder at rest, arrhythmias, shortness of breath, signs & symptoms of heart failure. MI, risk of QT prolongation w/ atypical antipsychotics; stroke. Potential sedation & wt gain. Presence of diabetes or development of hyperglycemia. Monitor glucose, lipids & wt; standing & supine blood pressure during 1st wk of treatment in patients w/ Parkinson's disease. Seizures, presence of prostatic enlargement, narrow-angle glaucoma, chronic constipation. Evaluate patients w/ high fever. Concomitant use of drugs w/ substantial potential to depress bone marrow function & long-acting depot antipsychotics. If discontinued abruptly, observed recurrence of psychotic symptoms & symptoms related to cholinergic rebound. Renal & hepatic impairment. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn, adolescents. Elderly ≥60 yr.
Adverse Reactions
Drowsiness/sedation, dizziness, tachycardia, constipation, hypersalivation. Leukopenia/decreased WBC/neutropenia, eosinophilia, leucocytosis, wt gain, dysarthria, seizures/convulsions/myoclonic jerks, extrapyramidal symptoms, akathisia, tremor, rigidity, headache, blurred vision, ECG change, syncope, postural hypotension, HTN, nausea, vomiting, dry mouth, elevated liver enzymes, urinary retention & incontinence, benign hyperthermia, disturbances in sweating/temp regulation, fatigue.
Drug Interactions
Alcohol, MAOIs, CNS depressants, narcotics, antihistamines, benzodiazepines, anticholinergic agents, antihypertensive agents, adrenaline, substances w/ resp depressant effects, valproic acid, omeprazole, cimetidine, erythromycin, rifampicin, phenytoin, carbamazepine, SSRIs, fluvoxamine, ciprofloxacin, lithium, azole antimycotics, PIs, caffeine intake, nicotine abuse, perazine, OCs.
MIMS Class
ATC Classification
N05AH02 - clozapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.
Clozaril tab 100 mg
5 × 10's
Clozaril tab 25 mg
5 × 10's
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