Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2013 Publisher: Rosemont Pharmaceuticals Ltd., Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK
Anticholinergic, for the treatment of all forms of Parkinsonism, including drug induced (neuroleptic syndrome).
Initially, 150mg daily in divided doses, increasing by 50mg every two or three days until maximum benefit is obtained. Optimal dosage is usually 250mg to 300mg daily in divided doses in idiopathic and post-encephalitic Parkinsonism; 100mg to 150mg daily in divided doses in arteriosclerotic parkinsonism; and 150mg to 300mg daily in divided doses in the neuroleptic syndrome.
Maximal dosage is 400mg daily in divided doses. The elderly may be more susceptible to side effects at doses which are clinically optimal.
Not recommended for use in children.
Adults: 2–3 g can be fatal for an adult though patients have survived doses of 5 g and 7.5 g.
Children: A 23 month old had severe toxicity after ingesting 300mg.
Toxicity is mainly due to anticholinergic effects at autonomic nerve endings and in the brain.
Common: Nausea, vomiting, flushing, dilated pupils, dry mouth and tongue, hot dry skin, fever, sinus tachycardia, hypertension, ataxia, nystagmus, drowsiness, delirium, agitation and visual hallucinations.
Uncommon: Myoclonic jerking, coma, convulsions, cardiac conduction abnormalities and dysrhythmias, cardiovascular collapse, paralytic ileus, urinary retention.
Activated charcoal or gastric lavage may be of benefit if the patient presents within 1 hour of having taken a potentially toxic amount.
Forced diuresis, haemodialysis and haemoperfusion are of no benefit.
Observe the mildest cases for at least 6 hours.
Monitor for and treat the following as clinically indicated: Airway patency, arterial blood gases (hypoxia and/or hypercapnoea may require oxygen or ventilation to correct), hypothermia or hyperthermia, hypotension (intravascular volume expanders or dopamine may be required), skin blisters (treat as burns), convulsions or delirium (can be treated with diazepam).
Resist the temptation to use antiarrythmic drugs. Correct hypoxia and administer sodium bicarbonate (even in the absence of acidosis).
Shelf life: 2 years.
Store below 25°C and avoid exposure to direct sunlight. Only dispense in amber glass bottles.
Bottles: Amber (Type III) glass.
Closures: HDPE, EPE wadded, tamper evident, child resistant closure.
Capacity: 150ml
Keep out of the reach of children.
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