Bromhexine has a high extraction ratio drug after intravenous administration (clearance is 843-1073 mL/min, within the range of the hepatic blood flow) resulting in high inter- and intraindividual variability (CV > 30%). After administration of radiolabelled bromhexine, about 97.4± 1.9% of the dose was recovered in the urine, with less than 1% as the parent compound.Bromhexine plasma concentrations showed a multi-exponential decline. After administrationbischesty-ccds0052-09-piv8-25oct19Page 7 of 11of single oral doses between 8 and 32 mg, the terminal half-life of bromhexine ranged between6.6 and 31.4 hours. The relevant half-life to predict the multiple dose pharmacokinetics isabout 1 hour. No accumulation was observed after multiple dosing (accumulation factor 1.1).Bromhexine is almost completely metabolised to a variety of hydroxylated metabolites and todibromanthranilic acid. Ambroxol is a metabolite of bromhexine.