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 ephedrine overdosage.
b) Treatment
In severe overdosage, the stomach should be emptied by emesis and lavage. Management is by supportive symptomatic therapy.
Polypropylene and polyethylene containers - Three years.
Blister strips - Two years
Ischaemic heart disease
Hypertension
Thyrotoxicosis
Prostatic hypertrophy
Ephedrine has positive inotropic and chronotropic effects on the heart and its use should be avoided in patients with ischaemic heart disease.
Ephedrine 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 ephedrine. Ephedrine may precipitate acute urinary retention in patients with prostatic hypertrophy.
None known
Lactose
Maize starch
Acacia spray-dried
Stearic acid
Magnesium stearate
Tablet
White, circular tablets marked E15 on one face and CP on the reverse.
The most common side-effects of ephedrine 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 ephedrine or pseudoephedrine.
Ephedrine 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 ephedrine.
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.
Studies in mice have shown that the lethal toxicity of ephedrine is increased by elevation of body temperature.
Ephedrine 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.
Ephedrine tablets are indicated for the treatment or prevention of attacks of bronchospasm in asthma.
Ephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors.
When given by mouth in therapeutic doses, ephedrine constricts the peripheral vessels, thus increasing blood pressure. It also relaxes bronchioles.
Ephedrine 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.
06/10/2015
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
United Kingdom
Do not store above 25°C.
Store in the original container in order to protect from light.
Polypropylene or polyethylene containers with tamper evident closure. Each pack contains 28, 30, 56, 60, 84, 90, 100, 250 or 1000 tablets.
Blister strips of 28, 30, 56, 60, 84, 90 tablets.
PL 29831/0085
Ephedrine hydrochloride 15mg
For excipients see 6.1
Ephedrine should be given with care to patients with hyperthyroidism, diabetes mellitus, angle-closure glaucoma and renal impairment.
Ephedrine 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.
Not applicable
| Adults | 15 - 60mg three times daily | |
| Children | under 1 year 1 - 5 years 6 - 12 years | not recommended 15mg three times daily 30mg three times daily |
| Elderly | Dosage should be substantially reduced. Initial therapy should be 50% of adult dose. | |
Not applicable
26/03/2007
