KEMADRIN Solution for injection Ref.[9753] Active ingredients:

The variation in optimum dosage from one patient to another should be taken into consideration by the physician.

Dosage in adults

Parkinson’s disease

Treatment is usually started at 2.5mg three times per day, increasing by 2.5 to 5mg daily at intervals of two or three days until the optimum clinical response is achieved.

The usual maintenance dose to achieve optimal response is 15 to 30mg procyclidine per day.

Addition of a fourth dose before retiring has been seen to be beneficial in some patients. Doses up to 60mg procyclidine have been well tolerated, and at the discretion of the attending physician dosing to this level may be appropriate.

In general younger patients or those with postencephalitic parkinsonism may require higher doses for a therapeutic response than older patients and those with arteriosclerotic parkinsonism.

Procyclidine may be combined with levodopa or amantadine in patients who are inadequately controlled on a single agent.

Neuroleptic-induced extrapyramidal symptoms

Treatment is usually initiated at 2.5mg procyclidine three times per day increasing by 2.5 mg daily until symptoms are relieved.

The effective maintenance dose is usually 10 to 30 mg procyclidine per day. After a period of 3 to 4 months of therapy, Procyclidine should be withdrawn and the patient observed to see whether the neuroleptic-induced extra-pyramidal symptoms recur.

If this is the case Procyclidine should be reintroduced to avoid debilitating extra-pyramidal symptoms. Cessation of treatment periodically is to be recommended even in patients who appear to require the drug for longer periods.

Procyclidine Injection may be given intramuscularly in doses of 5 to 10mg, repeated after 20 minutes if necessary, up to a daily maximum of 20mg procylidine.

In acute torsion dystonia and paroxysmal dyskinesias, doses of 5 to 10mg procyclidine intravenously are frequently effective within 5 to 10 minutes. Occasionally, patients may need more than 10 mg procyclidine, and may require up to half an hour to obtain relief.

Dosage in children

The use of in Procyclidine this age group is not recommended.

Dosage in elderly

Elderly patients may be more susceptible than younger adults to the anticholinergic effects of Procyclidine and a reduced dosage may be required (See Special Warnings and Special Precautions for Use).

Administration

Pharmacokinetic studies have indicated that the mean plasma elimination half life of Procyclidine is sufficient to allow twice daily administration orally or intravenously, if more convenient.

Oral administration may be better tolerated if associated with a meal.

Symptoms & Signs

Reports of overdosage are relatively rare and no fatalities are known. Symptoms of overdosage are agitation, restlessness and confusion with severe sleeplessness lasting up to 24 hours or more. Visual and auditory hallucinations have been reported. Most subjects are euphoric but the occasional patient may be anxious and aggressive. The pupils are widely dilated and unreactive to light.

In recorded cases, the disorientation has lasted 1 to 4 days and ended in a recuperative sleep. Tachycardia has also been reported in association with cases of Procyclidine overdose.

Treatment

If procyclidine has been ingested within the previous hour or two (or possibly longer in view of its likely effects on gastric motility) then gastric lavage is probably indicated. Other active measures such as the use of cholinergic agents or haemodialysis are extremely unlikely to be of clinical value although if convulsions occur they should be controlled by injections of diazepam.

5 years.

Store below 25°C.

2ml Neutral glass ampoules.

No special instructions.