Schizophrenia in patients unresponsive to, or intolerant of conventional antipsychotic drugs

Adult 18–59 years: 12.5 mg 1–2 times a day for day 1, then 25–50 mg for day 2, then increased, if tolerated, in steps of 25–50 mg daily, dose to be increased gradually over 14–21 days, increased to up to 300 mg daily in divided doses, larger dose to be taken at night, up to 200mg daily may be taken as a single dose at bedtime; increased in steps of 50–100 mg 1–2 times a week if required, it is preferable to increase once a week; usual dose 200–450 mg daily, max. 900mg per day, if restarting after interval of more than 48 hours, 12.5 mg once or twice on first day (but may be feasible to increase more quickly than on initiation)—extreme caution if previous respiratory or cardiac arrest with initial dosing.

Adult 60 years and over: 12.5 mg once daily for day 1, then increased to 25–37.5 mg for day 2, then increased, if tolerated, in steps of up to 25 mg daily, dose to be increased gradually over 14–21 days, increased to up to 300 mg daily in divided doses, larger dose at to be taken night, up to 200mg daily may be taken as a single dose at bedtime; increased in steps of 50–100 mg 1–2 times a week if required, it is preferable to increase once a week; usual dose 200–450 mg daily, max. 900mg per day, if restarting after interval of more than 48 hours, 12.5 mg once or twice on first day (but may be feasible to increase more quickly than on initiation)—extreme caution if previous respiratory or cardiac arrest with initial dosing.

Psychosis in Parkinson’s disease

Adult: 12.5 mg once daily, dose to be taken at bedtime, then increased in steps of 12.5 mg up to twice weekly, adjusted according to response; usual dose 25–37.5 mg once daily, dose to be taken at bedtime; increased in steps of 12.5 mg once weekly, this applies only in exceptional cases, increased if necessary up to 100 mg daily in 1–2 divided doses; usual maximum 50 mg/24 hour.

• Alcoholic and toxic psychoses
• Bone-marrow disorders
• Coma
• Drug intoxication
• History of agranulocytosis
• History of circulatory collapse
• History of neutropenia
• Paralytic ileus
• Severe cardiac disorders (e.g: myocarditis)
• Severe CNS depression
• Uncontrolled epilepsy

Age over 60 years: Prostatic hypertrophy, susceptibility to angle-closure glaucoma, taper off other antipsychotics before starting.

Further Information

Agranulocytosis Neutropenia and potentially fatal agranulocytosis reported, leucocyte and differential blood counts must be normal before starting; monitor counts every week for 18 weeks then at least every 2 weeks and if clozapine continued and blood count stable after 1 year at least every 4 weeks (and 4 weeks after discontinuation); if leucocyte count below 3000/mm3 or if absolute neutrophil count below 1500 /mm3 discontinue permanently and refer to haematologist, patients who have a low white blood cell count because of benign ethnic neutropenia may be started on clozapine with the agreement of a haematologist, avoid drugs which depress leucopoiesis; patients should report immediately symptoms of infection, especially influenza-like illness.

Myocarditis and cardiomyopathy Fatal myocarditis (most commonly in first 2 months) and cardiomyopathy reported, perform physical examination and take full medical history before starting specialist examination required if cardiac abnormalities or history of heart disease found—clozapine initiated only in absence of severe heart disease and if benefit outweighs risk persistent tachycardia especially in first 2 months should prompt observation for other indicators for myocarditis or cardiomyopathy if myocarditis or cardiomyopathy suspected clozapine should be stopped and patient evaluated urgently by cardiologist discontinue permanently in clozapine-induced myocarditis or cardiomyopathy.

Intestinal obstruction Impairment of intestinal peristalsis, including constipation, intestinal obstruction, faecal impaction, and paralytic ileus, (including fatal cases) reported, clozapine should be used with caution in patients receiving drugs that may cause constipation (e.g. Ant muscarinic drugs) or in those with a history of colonic disease or lower abdominal surgery, it is essential that constipation is recognized and actively treated.

Common or very common Appetite decreased, eosinophilia fever, headache, hypertension leucocytosis, nausea, oral disorders, speech impairment, sweating abnormal, syncope temperature regulation disorders, urinary disorders, vision blurred

Uncommon fall

Rare or very rare Anaemia, cardiac arrest, cardiac inflammation, cardiomyopathy, circulatory collapse, delirium, diabetes mellitus, dyslipidaemia, dysphagia, gastrointestinal disorders, glucose tolerance impaired, hepatic disorders, increased risk of infection, intestinal obstruction (including fatal cases), ketoacidosis, nephritis tubulointerstitial, obsessive-compulsive disorder, pancreatitis, pericardial effusion, respiratory disorders, restlessness, sexual dysfunction, skin reactions, sleep apnoea, thrombocytopenia, thrombocytosis.

Frequency not known Angina pectoris, angioedema, chest pain, cholinergic syndrome, diarrhoea, gastrointestinal discomfort, hypersensitivity vasculitis, mitral valve, Incompetence, Muscle complaints, Muscle weakness, Myocardial infarction, Nasal congestion palpitations, Polyserositis, Pseudo phaeochromocytoma, Renal failure, Rhabdomyolysis, Sepsis, Systemic lupus erythematosus (SLE).

Further Information

Hyper salivation associated with clozapine therapy can be treated with hyoscine hydro bromide (unlicensed indication), provided that the patient is not at particular risk from the additive ant muscarinic side-effects of hyoscine and clozapine.

Store in a cool and dry place

SIZONORM 25: 10×14 Tablets

SIZONORM 100: 10×10 Tablets