PROCHLORPERAZINE Solution for injection Ref.[8284] Active ingredients: Prochlorperazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London, EC4N 7BL, UK

Therapeutic indications

It is used in the symptomatic treatment of vertigo due to Meniere’s syndrome or labyrinthitis and for nausea and vomiting from whatever cause including that associated with migraine, schizophrenia (especially in the chronic stage), acute mania and as an adjunct to the short term management of anxiety.

Posology and method of administration

Posology

Treatment of nausea and vomiting: 12.5mg by deep I.M. injection followed by oral medication six hours later, if necessary.

Schizophrenia and other psychotic disorders: 12.5 to 25mg two or three times a day by deep I.M. injection until oral treatment becomes possible.

Elderly

Prochlorperazine should be used with caution in the elderly with psychotic disorders. Because elderly patients are susceptible to centrally acting drugs, lower initial dosage is recommended. Correct initial diagnosis of the disorder is important. Care should also be taken not to confuse adverse effects of prochlorperazine e.g. orthostatic hypotension with effects due to the primary disorder.

Paediatric population

Intramuscular Prochlorperazine should not be used in children under 18 years.

Method of administration

Prochlorperazine injection is for administration by intramuscular injection.

Overdose

Possible symptoms of phenothiazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia. E.C.G. changes, ventricular arrhythmias and hypothermia. Severe extra-pyramidal dyskinesias may occur. There is no specific antidote.

Treatment is symptomatic and supportive.

If the patient is seen sufficiently soon (up to 6 hours) after ingestion of a toxic dose, gastric lavage may be attempted. Pharmacological induction of emesis is unlikely to be of any use. Activated charcoal should be given.

Generalised vasodilatation may result in circulatory collapse; raising the patient’s legs may suffice and, in severe cases, volume expansion by intravenous fluids may be needed; infusion fluids should be warmed before administration to avoid aggravating hypothermia.

Positive inotropic agents such as dopamine may be considered if fluid replacement is insufficient to correct the circulatory collapse. Peripheral vasoconstrictor agents are not generally recommended and the use of adrenaline should be avoided.

Ventricular or supraventricular tachy-arrhythmias usually respond to restoration of normal body temperature and correction of circulatory or metabolic disturbances. If persistent or life threatening, appropriate anti-arrhythmic therapy may be considered. Avoid Lidocaine and, as far as possible, long acting anti-arrhythmic drugs.

Pronounced central nervous system depression requires airway maintenance or, in extreme circumstances, assisted respiration. Severe dystonic reactions usually respond to procyclidine (5-10mg) or orphenadrine (20-40mg) administered intramuscularly or intravenously. Convulsions should be treated with intravenous diazepam.

Neuroleptic malignant syndrome should be treated with cooling; dantrolene sodium may be tried.

Shelf life

Shelf life

Unopened: 3 years (36 months)*.

After reconstitution: Not applicable.

* If only part of an ampoule is used, the remainder should be discarded.

Special precautions for storage

Keep ampoules in the outer carton.

Do not store above 25°C.

Nature and contents of container

1ml and 2ml clear One Point Cut (OPC) glass ampoules, glass type 1 Ph.Eur. packed in cardboard cartons to contain 5x 1ml; 5 × 2ml; 10 × 1ml and 10 × 2ml ampoules.

Special precautions for disposal and other handling

For deep intramuscular injection.

Use as directed by the physician.

Keep out of reach of children.

If only part used, discard the remaining solution.

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