– Sedative antipsychotic
– Agitation or aggressive behaviour in patients with acute or chronic psychosis
Forms and strengths, route of administration
– 50 mg in 2 ml ampoule (25 mg/ml) for IM injection
– Adult: one injection of 25 to 50 mg. Subsequent doses, if needed, should be given at 8 hour intervals (max. 150 mg in 24 hours).
– Administer one-quarter of the usual dose in elderly patients.
– Change to oral treatment with another antipsychotic as soon as possible
Contra-indications, adverse effects, precautions
– Do not administer to patients with cardiac disorders (heart failure, recent myocardial infarction, conduction disorders, bradycardia, etc.), dementia (e.g. Alzheimer's disease), closed-angle glaucoma, prostate disorders, Parkinson's disease and history of neuroleptic malignant syndrome.
– Administer with caution and carefully monitor use in elderly patients; patients with hypokalaemia, hypotension, renal or hepatic impairment, history of seizures.
– May cause:
• drowsiness, dyskinesia, extrapyramidal syndrome, weight gain, orthostatic hypotension, hyperprolactinaemia, anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, tachycardia), pain at injection site;
• hyperglycaemia, photosensitivity, impaired thermoregulation; agranulocytosis, neuroleptic malignant syndrome (unexplained hyperthermia with neuromuscular disorders), rare but requiring immediate treatment discontinuation.
– Avoid combination with:
• central nervous system depressants (opioid analgesics, sedatives, H1 antihistamines, etc.); drugs with anticholinergic effects (amitriptyline, atropine, clomipramine, promethazine, etc.), antidiabetics, lithium;
• antihypertensive drugs (risk of hypotension); drugs that prolong the QT interval (amiodarone, chloroquine, erythromycin, fluconazole, mefloquine, pentamidine, quinine, etc.).
– Keep the patient in the supine position for 30 minutes after injection (risk of orthostatic hypotension).
– Pregnancy: avoid (risk of maternal hypotension)
– Breast-feeding: avoid
– Avoid contact with skin (risk of contact dermatitis).
– Storage: below 25 °C -