Each capsule contains Erdosteine 300 mg.
Each teasponful (5 mL) suspension contains Erdosteine 175 mg.
Pharmacotherapy: Erdosteine is classified under the mucolytic drugs.
Pharmcology: Erdosteine pharmacologically acts as a bronchial mucus fluidifying agent.
Pharmacodynamics: Erdosteine, besides its property of fluidifying bronchial mucus thus, facilitating expectorations, also shows effects as antagonizing of free radicals and as contrasting the action of elastase enzyme. Pharmacological studies show that erdosteine, as such, does not possess these properties but only after metabolism, transform into active metabolites which have the chemical -SH groups. These metabolites break the -SH groups and brings about a reduction in the mucus elasticity and viscosity thus, facilitating the expectoration.
The chemical -SH groups, distinctive of this activity, are chemically blocked and become free only after metabolism or in alkaline moiety. This property guarantees a good tolerability without bad tastes and without mercaptanic regurgitations and with good gastric tolerability.
Pharmacokinetics: Erdosteine is rapidly absorbed after oral administration; after a single oral dose, the Tmax is 1.2 hrs.
Erdosteine is rapidly metabolized into at least 3 active metabolites containing free thiol groups, ie.: N-thiodiglycolyl-homocysteine (metabolite I), N-acetyl-homocysteine (metabolite II) and homocysteine (metabolite III). The elimination half-life of erdosteine is 1.4 hrs on the average and that of the metabolite I and II of 1.2 and 2.7 hrs, respectively.
Multiple treatments do not modify the pharmacokinetics of erdosteine.
Age does not change the pharmacokinetics of erdosteine and of its metabolites.
Mucolytic, fluidifying agent in acute and chronic airways disorders.
Capsule: 1 capsule 2-3 times daily.
Dry Syrup: Children w/ body weight 15-19 kg: 5 mL, twice daily.
Children w/ body weight 20-30 kg: 5 mL, 3 times daily.
Children w/ body weight >30 kg and adults: 10 mL, twice daily.
With dosage exceeding 900 mg/day, sweating, vertigo and flushing have been observed.
Known individual hypersensitivity to this product.
Patients suffering from hepatic cirrhosis and cystathionine-synthetase enzyme deficiency.
Patients with severe kidney failure (creatinine clearance <25 mL/minute).
Effect of erdosteine in the ability to drive the vehicle and to operate the machinery: No effect has been reported.
Use in Pregnancy & Lactation: Safety of erdosteine in pregnancy has not been established and therefore, as with all new drugs, it is not recommended to be used in pregnancy and lactation period as well.
Dry Syrup: Products in granulation form (suspension) contains sucrose, thus it should be considered in the case of diabetes or low-calorie diet.
Safety of erdosteine in pregnancy has not been established and therefore, as with all new drugs, it is not recommended to be used in pregnancy and lactation period as well.
No gastrointestinal nor systemic side effects due to erdosteine has been observed. If undesirable effects occurred, inform the physician.
No harmful interaction have been observed with other drugs and erdosteine can be administered concomitantly with antibiotics, bronchodilators (eg, theophylline, β2-mimetics, cough sedatives, etc).
Directions for Reconstitution of Suspension: Add 50 mL of aquadest or boiled water into the bottle so that the final volume is as high as the boundary mark, then replace bottle cap and shake well.
Once reconstituted, the suspension must be used within 7 days, at the temperature below 30°C.
Store at temperature below 30°C in the tightly closed container and protect from sunlight exposure.
R05CB15 - erdosteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Cap 300 mg x 2 x 10's. Dry syr 175 mg/5 mL x 60 mL x 1's.