Ziproc-25/Ziproc-100 Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Clozapine

Indications/Uses

Treatment of schizophrenia; patients who fail to respond to or who experience severe extrapyramidal side-effects w/ classical antipsychotics. Reducing the risk of recurrent suicidal behavior in those w/ schizophrenia or schizoaffective disorder who are at risk of suicidal behavior. Management of treatment-resistant psychoses associated w/ Parkinson's disease.

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Dosage/Direction for Use

Schizophrenia including reducing the risk of suicidal behavior Usual dose: 12.5 mg once daily or bid on the 1st day followed by 25 mg bid on the 2nd day. Thereafter, may increase gradually in increments of 25-50 mg to achieve a daily dose of up to 300 mg w/in 2-3 wk. Subsequent increments of 50-100 mg may be made once or twice wkly. Therapeutic dose: 200-450 mg daily in divided doses. Max: 900 mg/day. Maintenance: 200 mg or less as a single dose. Ending therapy: W/drawn gradually over 1-2 wk period. Psychoses in Parkinson's disease Initially, <12.5 mg once daily, may increase to 12.5 mg w/ up to 2 increases each wk. 50 mg daily dose should not be reached before the end of 2nd wk. Therapeutic dose: 25-37.5 mg. Increases >50 mg should be made at wkly intervals. Max: 100 mg/day. Maintenance: may increase in wkly increments of 12.5-100 mg/day as a single dose or in 2 divided doses. Ending therapy: decrements of 12.5 mg over 1-2 wk.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Uncontrolled epilepsy, alcoholic or toxic psychoses, drug intoxication or history of circulatory collapse; patients w/ bone-marrow suppression, myeloproliferative disorders, abnormalities of WBC or differential count; history of drug-induced neutropenia or agranulocytosis w/ exception due to chemotherapy; history of cardiac impairment. Cardiac failure, paralytic ileus. Severe renal & hepatic impairment, liver disease.

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Special Precautions

Risk of agranulocytosis. Discontinue use if platelet count falls <50,000/nm³; if WBC count falls <3,000 cells/nm³ or ANC drops <1,500 cells/nm³; myocarditis is suspected. Baseline total & differential WBC count is required before initiation, during & after termination of treatment. Total counts should be monitored throughout therapy & 4 wk after discontinuation. Monitor for hyperglycemia especially in patients w/ or at risk of developing diabetes. Monitor BP for the 1st 2 wk of treatment in patients w/ Parkinson's disease. Monitor for fever, sore throat, flu-like symptoms or any other signs of infection. Reduce dose gradually over at least 1-2 wk period to avoid risk of rebound psychosis. May affect performance of skilled tasks eg, driving. Not recommended during pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Sedation, wt gain. Reversible neutropenia. Eosinophilia. Extrapyramidal disorders including tardive dyskinesia (rare). Tachycardia & orthostatic hypotension. Dizziness, hypersalivation, headache, nausea, vomiting, constipation, urinary incontinence & retention, anxiety, confusion, fatigue & transient fever.

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Drug Interactions

May enhance central effects of CNS depressants including alcohol, benzodiazepines & MAOIs. Drugs which carry a high risk of bone-marrow suppression including carbamazepine, cotrimoxazole, chloramphenicol, penicillamine, sulfonamides, antineoplastics or pyrazole analgesics eg, azapropazone; long-acting antipsychotics. Additive affects w/ antimuscarinic hypotensive, resp depressant drugs. Reduce effects of α-adrenoreceptor agonists eg, noradrenaline. Increased plasma conc w/ drugs that inhibit or act as a substrate to CYP450 & patients who suddenly stop smoking. May accelerate metabolism & reduce plasma conc w/ phenytoin or other enzyme-inducing drugs.

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Storage

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Description

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Action

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MIMS Class

Antipsychotics

ATC Classification

N05AH02 - clozapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.

Regulatory Classification

Presentation/Packing

Form

Ziproc-100 tab 100 mg

Packing/Price

100's (P6,517.86/box)

Form

Ziproc-25 tab 25 mg

Packing/Price

100's (P1,860/box)

Ziproc-25/Ziproc-100

clozapine

Manufacturer:

Torrent

Distributor:

Torrent