Mylan Phils


Metro Drug
Concise Prescribing Info
Schizoprenia in patients who are non-responsive to or intolerant to classic antipsychotics. Recurrent suicidal behavior w/ schizophrenia or schizoaffective disorders. Psychotic disorders occurring during the course of Parkinson's disease, in cases where standard treatment has failed.
Dosage/Direction for Use
Schizophrenia & recurrent suicidal behavior 12.5 mg once-bid on the 1st day, 25 or 50 mg on the 2nd day. May be increased up to 300-450 mg/day (in some patient 600 mg) in divided doses. Max: 900 mg/day. Psychotic disorders during the course of Parkinson's disease Starting dose must not exceed 12.5 mg/day in the evening followed by subsequent dose increase by 12.5 mg increments w/ max of 2 mg increments a wk up to max 50 mg. Mean effective dose: Between 25 & 37.5 mg/day as single dose in the evening. Max: 50 mg/day, to be exceeded only in exceptional cases. Dose of 100 mg/day must never be exceeded. Patient w/ CV disorders or mild to moderate renal impairment Initially 12.5 mg once on the 1st day & increased slowly & in small increments. Elderly ≥60 yr Initially 12.5 mg once on the 1st day w/ subsequent dose increments restricted to 25 mg/day.
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 (eg, myocarditis); active liver disease associated w/ nausea, anorexia or jaundice; progressive liver disease, hepatic failure; paralytic ileus.
Special Precautions
Agranulocytosis. Avoid concomitant use of drugs w/ substantial potential to depress bone marrow function & long-acting depot antipsychotics. Eosinophilia or thrombocytopenia. CV disorders (in particular if tachycardia persist at rest, possibly accompanied by arrhythmias, shortness of breath or signs & symptoms of heart failure). Discontinue if myocarditis is confirmed. Cardiomyopathy. Monitor standing & supine BP in patients w/ Parkinson's disease during the 1st wk of treatment. MI. Family history of QT prolongation. Stroke. Avoid patient immobilisation due to risk of thromboembolism. Risk of metabolic changes. Diabetes or development of symptoms of hyperglycemia. May lower seizure threshold. Prostatic enlargement, narrow-angle glaucoma & chronic constipation. May cause seizures, somnolence, postural hypotension, motor & sensory instability. Carefully evaluate patients w/ high fever to rule out possibility of infection, development of agranulocytosis or neuroleptic malignant syndrome. Liver dysfunction. Renal disorder. Avoid abrupt discontinuation. May impair 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, leukocytosis; wt gain; dysarthria; seizures/convulsions/myoclonic jerks, extrapyramidal symptoms, akathisia, tremor, rigidity, headache; blurred vision; ECG changes; 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, anticholinergics, antihypertensives, adrenaline, resp depressants, valproic acid, omeprazole, cimetidine, erythromycin, rifampicin, phenytoin, carbamazepine, SSRI, 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.
Leponex tab 100 mg
Leponex tab 25 mg
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in