ERDOMED sachets 225 mg. 20 sachets

€18

Mukolitik, liquefy secretions in acute and chronic diseases of the respiratory system.

Quantity

ERDOMED sachets 225 mg. 20 sachets

ERDOMED sachets 225 mg, Sachets of 225 mg 1 sachet contains: Active ingredient - erdosteine 225 mg Excipients - sucrose, sodium benzoate, sodium aminoglicolate, aspartam, lemon flavor 

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.

 

Formulations:

Hard capsules of 150 mg and 300 mg; Powder for oral-225 mg; granules for oral suspension 3.5% 7g / 200 ml;

 

Clinical data:

 

 Indications

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

 

 Contraindications

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.

 Interactions

 

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.

 

 

Adverse reactions

No reports of gastrointestinal or systemic intolerance. Possible hypersensitivity to any component.

 

Overdose

At doses higher than those recommended / 1200 mg daily / seen signs of sweating, dizziness and flushing.

 

 

 

Pharmacological:

Erdos / erdostein / manifests its effect through liquefaction of bronchial mucus.

 

 Pharmacodynamic properties

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.

 

  Pharmacokinetics

 

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

 

Acute toxicity:

LD / mice, rats, dogs po /> 5.000mg/kg

LD / rat intraperitoneally /> 5.000 mg / kg

LD / mice intravenously /> 3.500 mg / kg

 

Chronic toxicity:

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

 

Embryotoxicity:

Rats po - no toxicity at doses up to 1000 mg / kg

Rabbits po - no toxicity at doses up to 250mg/kg

 

Pharmaceutical Data

  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

 

Incompatibilities

No data.

 

  Expiration date

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.

 

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