Ephedrinum hydrochloricum WZF

Ephedrinum hydrochloricum WZFe tablets are indicated for the treatment or prevention of attacks of bronchospasm in asthma.

Ischaemic heart disease

Hypertension

Thyrotoxicosis

Prostatic hypertrophy

Ephedrinum hydrochloricum WZFe has positive inotropic and chronotropic effects on the heart and its use should be avoided in patients with ischaemic heart disease.

Ephedrinum hydrochloricum WZFe increases blood pressure in man. Over the counter acquisition of sympathomimetics should always be considered in hypertensive patients whose blood pressure control has suddenly deteriorated.

Patients with hyperthyroidism may be susceptible to the effects of Ephedrinum hydrochloricum WZFe. Ephedrinum hydrochloricum WZFe may precipitate acute urinary retention in patients with prostatic hypertrophy.

Ephedrinum hydrochloricum WZFe should be given with care to patients with hyperthyroidism, diabetes mellitus, angle-closure glaucoma and renal impairment.

Ephedrinum hydrochloricum WZFe has potentially life threatening effects in its acute cardiovascular and central stimulant effects.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Adverse reactions possible when combined with:

• Benzodiazepines

• CNS depressants

• Antidepressants

• MAO inhibitors

The most common side-effects of Ephedrinum hydrochloricum WZFe are tachycardia, anxiety, nausea, restlessness and insomnia. Tremor, dry mouth, impaired circulation to the extremities, hypertension, headache and cardiac arrhythmias may occur. Tolerance with dependence has been reported with prolonged administration.

Myocardial infarction has occurred very rarely in patients taking Ephedrinum hydrochloricum WZFe or pseudoEphedrinum hydrochloricum WZFe.

Ephedrinum hydrochloricum WZFe may act as stimulant in children with nocturnal enuresis and cause sleeplessness. It may have sedative effects in some children.

The elderly are more sensitive to the cardiovascular effects of Ephedrinum hydrochloricum WZFe.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

a) Symptoms

The symptoms of overdose are normally seen as nausea, vomiting, hypertension, fever, palpitations, tachycardia, restlessness, respiratory depression and convulsions. Paranoid psychosis, delusions and hallucinations may also follow Ephedrinum hydrochloricum WZFe overdosage.

b) Treatment

In severe overdosage, the stomach should be emptied by emesis and lavage. Management is by supportive symptomatic therapy.

Ephedrinum hydrochloricum WZFe is a sympathomimetic agent with direct and indirect effects on adrenergic receptors.

When given by mouth in therapeutic doses, Ephedrinum hydrochloricum WZFe constricts the peripheral vessels, thus increasing blood pressure. It also relaxes bronchioles.

Ephedrinum hydrochloricum WZFe is rapidly and completely absorbed after oral administration and extensively distributed throughout the body with accumulation in the liver, lungs, kidneys, spleen and brain.

Peak plasma concentrations are attained during therapy of 65-120 ug/ml, effective bronchodilator plasma levels are in the range 35-80 ug/ml.

The plasma half-life is reported to be between 3-11 hours, with up to 95% being excreted in the urine.

Studies in mice have shown that the lethal toxicity of Ephedrinum hydrochloricum WZFe is increased by elevation of body temperature.

Ephedrinum hydrochloricum WZFe induces acute locomotor stimulatory activity in rats and mice. The estimated lethal dose in children up to 2 years of age is 200mg and for adults 2g. Fatalities are rare and single doses up to 400mg have been given without serious toxic effects.

None known

Adverse reactions possible when combined with:

• Benzodiazepines

• CNS depressants

• Antidepressants

• MAO inhibitors