CHLORPROMAZINE Film-coated tablet Ref.[6659] Active ingredients: Chlorpromazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Dr. Reddys Laboratories (UK) Ltd, 6 Riverview Road, Beverley, HU17 0LD, UK

Therapeutic indications

Schizophrenia and other psychoses (especially paranoia), mania and hypomania. In anxiety, psychomotor agitation, excitement, violent or dangerously impulsive behaviour. Is used as an adjunct in the short-term management of these conditions.

Intractable hiccup.

Nausea and vomiting in terminal illness (where other drugs have failed or are not available).

Induction of hypothermia is facilitated by Chlorpromazine Tablets which prevents shivering and causes vasodilatation.

Childhood schizophrenia and autism.

Posology and method of administration

Dosages should be low to begin with and gradually increased under close supervision until the optimum dosage for the individual is reached. Individuals vary considerably and the optimum dose may be affected by the formulation used.

Dosage of chlorpromazine in schizophrenia, other psychoses, anxiety and agitation etc.

Adult: Initially 25 mg t.d.s. or 75 mg at bedtime increasing by daily amounts of 25 mg to an effective maintenance dose. This is usually in the range 75 to 300 mg daily but some patients may require up to 1 g daily.

Children under 1 year: Do not use unless need is life saving.

Children 1-5 years: 0.5 mg/kg body weight every 4-6 hours to a maximum recommended dose of 40 mg daily.

Children 6-12 years: 1/3-½ adult dose to a maximum recommended dose of 75 mg daily.

Elderly or debilitated patients: Start with 1/3-½ usual adult dose with a more gradual increase in dosage.

Hiccups

Adult: 25-50 mg t.d.s. or q.d.s.

Children under 1 year: No information available.

Children 1-5 years: No information available.

Children 6-12 years: No information available.

Elderly or debilitated patients: As for adults.

Nausea and vomiting of terminal illness

Adults: 10-25 mg every 4-6 hours.

Children under 1 year: Do not use unless need is life saving.

Children 1-5 years: 0.5 mg/kg every 4-6 hours. Maximum daily dosage should not exceed 40 mg.

Children 6-12 years: 0.5 mg/kg every 4-6 hours. Maximum daily dosage should not exceed 75 mg.

Elderly or debilitated patients: Initially 1/3-½ adult dose. The physician should then use his clinical judgment to obtain control.

Method of administration

Oral.

Overdose

Symptoms of chlorpromazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, E.C.G. changes, ventricular arrhythmias and hypothermia. Severe extra-pyramidal dyskinesias may occur.

Treatment should by symptomatic with continuous respiratory and cardiac monitoring (risk of prolonged QT interval) until the patient’s condition resolves.

If the patient is seen up to 6 hours after ingestion of a toxic dose, gastric lavage may be attempted. Induction of emesis is unlikely to be of any use. Activated charcoal should be given. There is no specific antidote. Treatment is supportive.

Generalised vasodilatation may result in circulatory collapse; raising the patient’s legs may suffice, in severe cases, volume expansion by intravenous 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. Avoid use of adrenaline. Ventricular or supraventricular tachyarrhythmia’s usually respond to restoration of normal body temperature and correction of circulatory or metabolic disturbances. If persistent or life threatening, appropriate antiarrhythmic therapy may be considered. Avoid lignocaine and, as far as possible, long acting antiarrhythmic drugs.

Central nervous system depression requires airway maintenance or, in extreme circumstances, assisted respiration. Severe dystonic reactions usually respond to procyclidine (5-10 mg) or orphenedrine (20-40 mg) 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

3 years.

Special precautions for storage

Do not store above 25°C. Store in the original package.

Nature and contents of container

High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane/polythene wads.

250 micron PVC glass-clear/green rigid PVC (pharmaceutical grade). 20 micron hard-tempered aluminium foil coated on the dull side with 6-7 gsm heat seal lacquer and printed on the bright side.

Packs of 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000 tablets.

Special precautions for disposal and other handling

Not applicable.

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