EPHEDRINE HYDROCHLORIDE Solution for injection Ref.[7873] Active ingredients: Ephedrine

Posology

Adults and the elderly

Up to 30 mg in increments of 3-7.5 mg.

After the development of hypotension, by slow intravenous injection.

Paediatric population

Ephedrine Hydrochloride 30 mg/ml Solution for Injection is generally not recommended for use in children due to insufficient data on efficacy, safety and dosage recommendations.

Children under 12 years

The safety and efficacy of Ephedrine in paediatric patients under 12 years have not been established. No data are available.

Children over 12 years

The posology and method of administration is the same as for adults.

Method of administration

Intravenous use.

For instructions on dilution of the medicinal product before administration, see section 6.6.

Symptoms

In the event of overdose, the occurrence of nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias, hypertension, respiratory depression, convulsions and coma is observed.

The lethal dose in humans is approximately 2 g corresponding to blood concentrations of approximately 3.5 to 20 mg/l.

Treatment

The treatment of ephedrine overdose with this product may require intensive supportive treatment. Slow intravenous injection of labetalol 50-200 mg may be given with electrocardiograph monitoring for the treatment of supraventricular tachycardia. Marked hypokalaemia (<2.8 mmol/l) due to compartmental shift of potassium predisposes to cardiac arrhythmias and may be corrected by infusing potassium chloride in addition to propranolol and correcting respiratory alkalosis, when present.

A benzodiazepine and/or a neuroleptic agent may be required to control CNS stimulant effects.

For severe hypertension, parenteral antihypertensive options include intravenous nitrates, calcium channel blockers, sodium nitroprusside, labetalol or phentolamine. The choice of antihypertensive drug is dependent on availability, concomitant conditions and the clinical status of the patient.

Unopened: 3 years.

Diluted solution: Chemical and physical in-use stability has been demonstrated for 72 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

This medicinal product does not require any special temperature storage conditions.

Keep the container in the outer carton in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

1 ml colourless glass one-point-cut (OPC) ampoules, type I containing 1 ml solution for injection. Packed into cartons of 5 or 10 ampoules.

Not all pack sizes may be marketed.

For single use only.

Ephedrine hydrochloride is compatible with sodium chloride 9 mg/ml (0.9%), Ringer’s lactate solution and glucose 50 mg/ml (5%).

The drug product should be examined visually and should not be used if particulate matter or discolouration are present.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.