It is used for schizophrenia and for psychotic disorders associated with Parkinson's disease when standard therapy is ineffective.
Each tablet contains:
Active ingredient: Clozapine – 100 mg
Excipients: Microcrystalline cellulose, lactose monohydrate, corn starch, povidone, sodium starch glycolate, magnesium stearate
Schizophrenia, including treatment-resistant forms
Patients with schizophrenia who experience severe neurological side effects from other antipsychotic medications, including atypical antipsychotics
Psychotic disorders associated with Parkinson's disease when standard treatment is ineffective
The dose should be individualized, using the minimum effective dose.
Treatment should begin only in patients with normal leukocyte levels (WBC ≥ 3.5 × 10⁹/L and neutrophils ≥ 2.0 × 10⁹/L).
During the first 18 weeks of therapy, white blood cell and neutrophil counts should be monitored weekly, and then every 4 weeks during ongoing treatment.
Discontinue treatment if WBC < 3.0 × 10⁹/L or neutrophils < 1.5 × 10⁹/L.
Patients who discontinue due to low WBC or neutrophils should not be re-treated with clozapine.
For treatment-resistant schizophrenia:
Start with 12.5 mg once or twice daily (after meals) on day 1.
On day 2, increase to 25 mg once or twice daily.
If tolerated, the daily dose may be gradually increased by 25–50 mg every few days to reach 300 mg/day within 2–3 weeks.
If necessary, the dose may be increased by 50–100 mg at intervals, with a maximum daily dose of 900 mg.
Doses above 450 mg/day increase the risk of side effects, especially seizures.
Maintenance dose: After achieving therapeutic response, most patients may be maintained on a lower dose. Gradual reduction is recommended.
Minimum treatment duration: 6 months.
If the daily dose does not exceed 200 mg, it may be taken in a single evening dose.
At the end of therapy, taper the dose over 1–2 weeks.
If therapy must be stopped abruptly, monitor for withdrawal symptoms.
If restarting after ≥2 days of interruption, begin again with 12.5 mg once or twice daily and titrate cautiously.
For psychotic disorders in Parkinson’s disease (when standard therapy fails):
Initial dose: 12.5 mg in the evening.
Increase by 12.5 mg twice a week, up to 50 mg/day in the second week.
Preferably administered as a single evening dose.
Average effective dose: 25–37.5 mg/day.
If no effect is achieved within one week at 50 mg/day, the dose may be cautiously increased by 12.5 mg per week.
Maximum dose: 100 mg/day (exceeding this is not allowed).
At therapy end, taper dose by 12.5 mg over 1–2 weeks.
Discontinue immediately in case of neutropenia or agranulocytosis.
Hypersensitivity to clozapine or any ingredient in the formulation
History of toxic or idiosyncratic granulocytopenia/agranulocytosis (excluding chemotherapy-induced)
Agranulocytosis caused by previous clozapine use
Bone marrow disorders
Uncontrolled epilepsy, spasmophilia, myasthenia gravis
Psychoses caused by alcohol or other toxic substances, drug intoxication, coma
Circulatory collapse or CNS depression from other causes
Severe heart or kidney diseases (e.g., myocarditis)
Acute liver disease with symptoms such as nausea, anorexia, or jaundice, progressive liver damage or liver failure
Paralytic ileus
Concomitant use with medications that may cause agranulocytosis
Prostate hyperplasia
Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
Inability to comply with regular blood monitoring
Store in a dry place, away from light and moisture, at a temperature between 15°C and 25°C.
Keep out of reach of children.
Shelf life: 3 years. Do not use after the expiration date indicated on the packaging.
