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

Pharmacodynamic properties

Ephedrine hydrochloride is applied locally to relieve congestion of mucous membranes in acute sinusitis and hay fever. It has a stimulant action on the respiratory centre. Ephedrine releases norepinephrine from storage sites in the sympathetic nerves to the effector organ. It exhibits tachyphylaxis; repeated infusions become less effective as the releasable stores of norepinephrine are depleted.

Ephedrine redistributes the blood flow and causes cardiac stimulation, without markedly raising the blood pressure.

Sympathomimetic drugs exert their effect by vasoconstriction of the mucosal blood vessels, which in turn reduces the thickness of the nasal mucosa. However, they can give rise to a rebound phenomenon as their effects wear off, due to a secondary vasodilation with a subsequent temporary increase in nasal congestion.

Pharmacokinetic properties

Ephedrine is readily and completely absorbed from the gastro-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine, together with small amounts of metabolites produced by hepatic metabolism. Ephedrine has been variously reported to have a plasma half-life ranging from 3 to 6 hours depending on urinary pH; elimination is enhanced and half-life accordingly shorter in acid urine.

Preclinical safety data

No data of relevance, which is additional to that included on other sections of the SPC.

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