Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK
Alimemazine has powerful antihistamine and anti-emetic actions and is used in the management of urticaria and pruritus.
Alimemazine may be used in pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years. The alimemazine syrup formulation is suitable for these indications in children.
Do NOT exceed the recommended dose (see also section 4.9).
Adults: 10mg two or three times daily.
Elderly: Dosage should be reduced to 10mg once or twice daily.
Paediatric population: Not recommended for infants less than 2 years old.
Children over 2 years of age: The use of Alimemazine Syrup is recommended.
The dosage for children is best achieved by use of Alimemazine Syrup.
Oral.
Symptoms of phenothiazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extra-pyramidal dyskinesias may occur.
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. 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. Peripheral vasoconstrictor agents are not generally recommended; avoid the use of adrenaline.
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 (NMS) has been reported in the context of alimemazine overdose. Symptoms of NMS include a combination of hyperthermia, muscle rigidity, altered mental status and autonomic instability. Since this syndrome is potentially fatal, alimemazine must be discontinued immediately, and intensive clinical monitoring and symptomatic treatment must be initiated.
Strict adherence to the recommended dose is critical (see also section 4.2)
Neuroleptic malignant syndrome should be treated with cooling. Dantrolene sodium may be tried.
Shelf life: 36 months.
Do not store above 30°C. Store in the original package in order to protect from light.
Tablets are packed in blisters containing 28 tablets.
No special requirements.
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