AVOMINE Tablet Ref.[27737] Active ingredients: Promethazine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2018  Publisher: sanofi-aventis new zealand limited, Level 8, James and Wells Tower, 56 Cawley Street, Ellerslie, Auckland, Telephone: (09) 580 1810

4.1. Therapeutic indications

Prevention and treatment of motion sickness.

4.2. Posology and method of administration

Adults – Travel sickness

Prevention

Long journeys: 1 tablet each night at bedtime commencing on the night before travelling.

Short journeys: 1 tablet to be taken 1 to 2 hours before the journey commences.

Treatment

1 tablet followed by a second tablet the same evening and a third tablet on the following evening. Prompt treatment is important. Additional tablets may safely be taken as a preventive or when they appear to be needed but it will seldom be necessary to give more than 4 tablets in 24 hours or to repeat a dose in less than 8 hours.

4.9. Overdose

Overdose – Symptoms

Symptoms of severe overdosage are variable. The chief symptom of acute poisoning from the ingestion of promethazine is unconsciousness which is, however, commonly delayed. Symptoms are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children: coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon.

Overdose – Treatment

An immediate first aid measure is to induce vomiting mechanically or to give an emetic, the value of which, however, is limited by the antiemetic activity of Avomine once absorbed. The most important step in treatment must be, therefore, to remove as much as possible of the unabsorbed material by means of gastric lavage with warm sodium bicarbonate solution. Some sodium bicarbonate solution should be left in the stomach to precipitate insoluble promethazine base, thus delaying its absorption. Should convulsions occur, special care must be taken of the use of sedatives which may increase the depression of respiration. Intravenous amphetamine or intramuscular ephedrine should be given for CNS stimulation, if indicated. Oxygen under pressure should be given if respiration is depressed. The administration of an antibiotic as a prophylactic against pneumonia should be considered.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

6.3. Shelf life

36 months from date of manufacture.

6.4. Special precautions for storage

Store below 30°C.

Protect from light.

6.5. Nature and contents of container

Blister packs containing 10 tablets.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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