EPHEDRINE HYDROCHLORIDE Tablet Ref.[7877] Active ingredients: Ephedrine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, United Kingdom

Pharmacodynamic properties

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.

Pharmacokinetic properties

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.

Preclinical safety data

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.

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