ERDOMED sachets 225 mg. 20 sachets
ERDOMED sachets 225 mg. 20 sachets
Qualitative and quantitative composition:
Sachets of 225 mg
1 sachet contains:
Active ingredient - erdosteine 225 mg
Excipients - sucrose, sodium benzoate, sodium aminoglicolate, aspartam, lemon flavor.
Hard capsules of 150 mg and 300 mg; Powder for oral-225 mg; granules for oral suspension 3.5% 7g / 200 ml;
Mukolitik, liquefy secretions in acute and chronic diseases of the respiratory system.
Dosage and administration:
Sachets 225 mg / adult / 1 sachet 2-3 times a day
Hypersensitivity to any component of the product.
Erdos is contraindicated in patients with liver cirrhosis and deficiency of the enzyme cystathionine synthetase as metabolites influence the metabolism of methionine.
Granules suspension are contraindicated in phenylketonuria because they contain aspartame.
Erdos is contraindicated in pregnant women and nursing mothers.
Special warnings and special precautions for use
Granules and suspension contains sucrose and should be used with caution in diabetics or low-calorie diet.
There are no reports of interactions with other drugs, so the product can be administered with antibiotics, bronchodilators / Theophylline and beta-2-agonists / and funds, cough suppressants.
Pregnancy and lactation
Safety erdostein use during pregnancy has not been established and therefore its use in such cases is not recommended.
Erdostein should not be taken by nursing mothers.
Effects on ability to drive and use machines.
Does not affect the ability to drive and use machines.
No reports of gastrointestinal or systemic intolerance. Possible hypersensitivity to any component.
At doses higher than those recommended / 1200 mg daily / seen signs of sweating, dizziness and flushing.
Erdos / erdostein / manifests its effect through liquefaction of bronchial mucus.
Pharmacotherapeutic group: Erdosteine is classified in the group of mukolititsite.
Mechanism of action / pharmacodynamic effects /:
Erdosteine, the active ingredient in Erdos, liquefies bronchial mucus and facilitates expectoration, inhibits formation "in loco" of free radicals, which inhibit the enzyme elastase. Pharmacological studies show that erdostein himself possesses such properties and are only active metabolites. Actually SH groups that have this activity are chemically bonded and released after metabolism or in an alkaline environment. This feature ensures their good gastric tolerability, no bad smell when burping Merkantil.
Maximum plasma concentrations are reached within 30 to 60 minutes. The product undergoes biotransformation to obtain related metabolites. In oral bioavailability is very high. Different pharmaceutical forms - capsules, granules and suspension are bioequivalent.
Preclinical safety data
LD / mice, rats, dogs po /> 5.000mg/kg
LD / rat intraperitoneally /> 5.000 mg / kg
LD / mice intravenously /> 3.500 mg / kg
Rats / po - 52 weeks / no toxicity at doses up to 1.000 mg / kg
Dogs / po - 52 weeks / no toxicity at doses up to 2000mg/kg
Rats po - no toxicity at doses up to 1000 mg / kg
Rabbits po - no toxicity at doses up to 250mg/kg
List of excipients and their amounts:
Granules of 225 mg
Sucrose 3999.85 mg
Sodium benzoate 13 mg
130 mg Sodium amidoglicolate
Aspartam 50 mg
Lemon flavor powder 8 mg
In intact packaging:
150 Capsules 300 mg - 5 years
Sachets with granules 225 mg - Suspension 3.5%, 7 g/200 ml: 3 years
Special precautions for storage
The reconstituted suspension may be used at most 14 days after reconstitution when stored properly.