PROCHLORPERAZINE Tablets Ref.[8282] Active ingredients: Prochlorperazine

Posology

Elderly

Use with caution in this age group in psychotic disorders. Owing to the susceptibility of elderly patients to centrally acting drugs, lower initial dosage is recommended. Care should be taken not to confuse adverse effects of prochlorperazine (eg orthostatic hypotension) with effects due to the primary disorder.

Vertigo and Meniere’s syndrome

Adults

5mg three times daily, increasing where necessary to a maximum of 30mg daily. After several weeks of therapy, dosage may be gradually reduced to 5-10mg daily.

Nausea and vomiting

Adults

Prevention: 5-10mg two or three times daily.

Treatment: 20mg immediately, followed by, if necessary, 10mg two hours later.

Adjunct to the short-term management of anxiety

Adults

15-20mg daily in divided doses, increasing where necessary to a maximum of 40mg daily in divided doses.

Schizophrenia and other psychotic disorders

Usually 75-100mg daily, but patients vary widely in response. The following dosage regime is suggested: Initially 12.5mg twice daily for seven days, rising by 12.5mg increments at four to seven day intervals until a satisfactory response is obtained. After some weeks at the effective dosage level, an attempt should be made to reduce the dosage. Total daily dosages as low as 50mg, or even 25mg, have sometimes found to be adequate.

Paediatric population

Not recommended for children under 12 years of age.

To reduce side effects gradual withdrawal of treatment is advisable.

Method of Administration

For oral administration.

Symptoms of phenothiazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extrapyramidal dyskinesias may occur.

If the patients 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. There is no specific antidote. Treatment is supportive. Adrenaline (Epinephrine) must not be used in patients who have overdosed with prochlorperazine maleate.

Generalised vasodilatation may result in circulatory collapse; raising the patient’s legs may suffice, in severe cases, volume expansion by iv fluids may be needed; infusion fluids should be warmed before administration in order not to aggravate hypothermia.

Positive inotropic agents such as dopamine may be tried if fluid replacement is insufficient to correct the circulatory collapse. Peripheral vasoconstrictor agents are not generally recommended; avoid the use of adrenaline (epinephrine).

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 CNS 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 iv diazepam. Neuroleptic malignant syndrome should be treated with cooling. Dantrolene sodium may be tried.

Shelf-life: Three years from the date of manufacture (PVC blister packs).

Two years from the date of manufacture (polypropylene containers; polyethylene containers; amber glass bottles).

Store below 25°C in a dry place. Protect from light.

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool.

The product may also be supplied in blister packs and cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250s, 500s, 1000s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material.

Maximum size of bulk packs: 50,000.

Not applicable.