Each tablet contains: Clozapine 25 mg and 100 mg.
Pharmacology: Clozapine is classified as an atypical antipsychotic agent, which differs from conventional antipsychotics. It has a weak dopamine receptor blocking activity at D2 receptors, but has a D1 anti-adrenergic, anticholinergic, antihistaminergic and arousal reaction inhibiting effects. It has also been shown to possess antiserotonergic property. Clozapine produces rapid and marked sedation and exerts strong antipsychotic effects. It is effective in patients exhibiting both positive and negative schizophrenic symptoms.
Used for the management of schizophrenia; reserved for patients who fail to respond to, or who experience severe extrapyramidal side-effects with classical antipsychotics.
Adults: 25 mg to 50 mg on the first day. The dose may be increased in daily increments of 25-50 mg up to 300 mg per day. Maximum of 900 mg per day. Or as prescribed by the physician.
Symptoms of overdosage are drowsiness, lethargy, coma, areflexia, confusion, agitation, hyperflexia, delirium, convulsions, hypersalivation, mydriasis, blurred vision, thermolability, tachycardia, hypotension, collapse, cardiac arrhythmia and respiratory depression. Management of overdosage include gastric lavage followed by administration of activated charcoal, symptomatic treatment under continuous cardiac monitoring, surveillance of respiration, control of electrolytes and acid base balance. The use of adrenaline and its derivative should be avoided for treatment of hypotension because of possibility of "reverse adrenaline" effect.
Close medical supervision is necessary for at least four days because of possibility of delayed reactions.
Do not use in patients hypersensitive to the drug. Patients with history of drug induced neutropenia/agranulocytosis or with myeloproliferative disorders must not be treated with clozapine. Other contraindications are alcoholic and toxic psychoses, drug intoxication, comatose conditions and other forms of severe central nervous system depression, severe hepatic and renal disease.
Clozapine can cause agranulocytosis. Patients who are being treated with clozapine must have a baseline total WBC and differential WBC count before initiation of the treatment. WBC counts throughout the treatment and even after termination of the treatment is also required. The total counts should be monitored every week for 4 months and thereafter every fortnight till 4 weeks after discontinuing the therapy.
Use in pregnancy & lactation: The safe use of Clozapine in pregnancy has not been established and its use is not recommended. Animal studies suggest that Clozapine is excreted in breast milk, therefore, mothers receiving Clozapine must not breast feed.
The safe use of Clozapine in pregnancy has not been established and its use is not recommended. Animal studies suggest that Clozapine is excreted in breast milk, therefore, mothers receiving Clozapine must not breast feed.
Dizziness and fatigue are among the most common side effects observed. Other adverse reactions of CNS include seizures, dizziness and headache. Extrapyramidal symptoms are limited mainly to tremor, akathisia, and rigidity. All these effects are mild to transient. Dry mouth, disturbance in sweating and temperature regulation have been reported. Adverse effects on CVS include tachycardia, postural hypotension especially in the initial weeks of the treatment. In rare cases, circulatory collapse accompanied by respiratory depression or arrest has been reported. In GIT, side effects like nausea, vomiting and constipation may occur. Increase hepatic enzymes and in rare cases cholestasis have been reported
Clozapine may enhance central effects of alcohol, MAO inhibitors, CNS depressants including narcotics, benzodiazepines and sedative antihistaminics. Caution is advised with patients who are receiving (or have recently received) benzodiazepines as the increased risk of circulatory collapse accompanied by respiratory depression are involved. Because of the additive effects, caution should be applied with concomitant administration of drugs with anticholinergic, hypotensive or respiratory depression effects. Other drugs which may have the potential to depress bone-marrow function (e.g. Carbamazepine, Captopril, and Propythiouracil), may increase the risk of agranulocytosis associated with clozapine.
Store at temperatures not exceeding 30°C.
N05AH02 - clozapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.
Ziproc-25 tab (light yellow, round, biconvex uncoated tablets with bisecting line on one side) 25 mg x 100's. Ziproc-100 tab (light yellow, round, biconvex uncoated tablets with bisecting line on one side) 100 mg x 100's.