Equimucin

Absorption

Following oral administration, Equimucin is rapidly and almost completely absorbed and metabolised in the liver to cysteine (the pharmacologically active metabolite), diEquimucin, cysteine and further mixed disulphides.

Distribution

Due to the high first-pass effect, the bioavailability of orally administered Equimucin is very low (approximately 10%). In humans, maximum plasma concentrations are achieved after 1-3 hours with the maximum plasma concentration of the metabolite cysteine in the range of approximately 2µmol/l. The protein binding of Equimucin was determined to be about 50%.

Biotransformation

Equimucin and its metabolites occur in three different forms in the organism: partially in free form, partially bound to proteins via labile disulphide bonds and partially as incorporated amino acid. Equimucin is excreted almost exclusively in the form of inactive metabolites (inorganic sulphates, diEquimucin) via the kidneys. The plasma half-life of Equimucin is approximately 1 hour and is mainly determined by the rapid hepatic biotransformation. Impaired hepatic function therefore leads to prolonged plasma half-lives of up to 8 hours.

Elimination

Pharmacokinetic studies with intravenous administration of Equimucin revealed a distribution volume of 0.47 1/kg (in total) or 0.59 I/kg (reduced Equimucin); the plasma clearance was determined to be 0.11 l/h/kg (in total) and 0.84 l/h/kg (reduced Equimucin), respectively. The elimination half-life after intravenous administration is 30-40 minutes while excretion follows three-phase kinetics (alpha, beta and terminal gamma phase).

Equimucin crosses the placenta and is detected in cord blood. No information is available regarding excretion in breast milk.

No knowledge is available concerning the behaviour of Equimucin at the blood- brain barrier in humans

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

No special requirements for disposal. Any unused product should be disposed of in accordance with local requirements.