EPHEDRINE 1.0% Nasal drops Ref.[7876] Active ingredients: Ephedrine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Thornton & Ross Ltd, Linthwaite Laboratories, Huddersfield, HD7 5QH

Therapeutic indications

For the relief of nasal congestion.

Posology and method of administration

Nasal, by application to the mucous membranes.

Recommended dose

Instil one or two drops into each nostril.

Dosage schedule

As required, but not more than 4 times a day.

The above dose and schedule are recommended for adults, the elderly and children over 12 years.

Overdose

The estimated minimal lethal dose of ephedrine in children up to 2 years of age is 200mg, and for adults 2g, but fatalities due to ephedrine overdose are rare and not likely to occur following administration of the nasal drops. Single doses of up to 400mg of ephedrine have been given without serious toxic effects. In large doses ephedrine may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia. Paranoid psychosis, delusions, and hallucinations may follow overdosage. Treatment of overdosage should include supportive and symptomatic therapy. In severe cases the stomach should be emptied by aspiration and lavage. Diazepam may be given to control central nervous system stimulation.

Chlorpromazine may be given for excitement or the management of hallucinations. A beta-adrenoceptor blocking agent may be required to control cardiac arrhythmias. Acute poisoning with chlorobutanol is also highly improbable considering the concentration in the drops and the method of administration, however treatment for overdosage would be aspiration and lavage.

Shelf life

10 ml: 18 months unopened, 2 months after first opening.

500 ml: 18 months unopened.

Special precautions for storage

Store below 25°C.

Nature and contents of container

10 ml: amber glass, winchester bottle with 20mm R3 plastic wadded cap.

Special precautions for disposal and other handling

None.

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