Conditions for the Use of Mucolytics in Children Are Tightening in Europe − Which Treatment Is Preferred?
There has been a long-standing discussion among experts regarding the benefits of individual mucomodulatory drugs in the treatment of productive cough in children. According to current recommendations, erdosteine remains the preferred treatment for children. At what age can mucolytic treatment be safely recommended?
The Importance of Erdosteine in the Early Stages of Respiratory Infections
The majority of respiratory infections in children (> 80%) are of viral origin. These are mostly caused by rhinoviruses, influenza A and B viruses, adenoviruses, parainfluenza viruses, and RSV. In cases of viral infections, the empirical use of antibiotics (ATB) is entirely inappropriate. Exceptions include patients with severe comorbidities or immunosuppression, where ATB is used as a prevention for bacterial superinfection.
Newly manifesting respiratory infections are often accompanied by a cough, initially dry, later productive. Besides its mucolytic effect, timely administration of erdosteine, due to its anti-adhesive, anti-inflammatory, and antioxidant effects, limits bacterial colonization and reduces the risk of bacterial superinfection. Erdosteine also increases the concentration of the immunoglobulin IgA on the respiratory mucosa. It follows that administering erdosteine at the onset of a respiratory infection can avoid the need for antibiotics. Additionally, in bacterial infections where antibiotic treatment has already been initiated alongside erdosteine, a better penetration of antibiotics into the mucus is confirmed, leading to faster pathogen eradication and a reduction in the duration of respiratory symptoms.
Respiratory infections have a significant epidemiological, socio-economic, and pharmacoeconomic impact. The use of multimodally acting erdosteine in the early stages of respiratory infections can eliminate unnecessary antibiotic therapy and lead to lower treatment costs.
At What Age Can Mucolytics Be Safely Used?
From the perspective of current knowledge and evidence-based medicine principles, the risks of administering mucolytic agents in children < 2 years old outweigh the potential benefits of such therapy. In young children, the administration of some mucolytic agents can lead to paradoxical mucus hypersecretion due to excessive stimulation of goblet cells. Small children often swallow and then vomit the mucus, which can result in dehydration. Therefore, the recommended treatment involves suctioning the mucus and ensuring adequate hydration, which itself aids in mucolysis.
According to the Czech Pediatric Society CLS JEP, in collaboration with the Czech Society for Pediatric Pneumology CLS JEP, erdosteine is considered the most effective mucolytic, with precise dosage established from a body weight of 15 kg. This weight category roughly corresponds to the age > 2 years, the age at which the use of mucolytic agents is considered beneficial.
However, the age restriction of 2 years does not apply to all mucolytic drugs and for all pediatric patients. According to recommendations from the European Medicines Agency (EMA), due to prevailing risks, bromhexine-containing preparations should be used only from the age of 4, and ambroxol-containing preparations from the age of 6. In children with chronic lung diseases (e.g., cystic fibrosis), the use of mucolytic agents may be necessary and beneficial even < 2 years old.
Rules for Administering and Dosing Erdosteine
The most suitable dosage form for children is an oral suspension. The dosing of the preparation is based on the body weight and age of the child, as follows:
- 15−20 kg (3−6 years): 2.5 ml 2x daily
- 21−30 kg (7−12 years): 5 ml 2x daily
- > 30 kg (over 12 years): 5 ml 3x daily
Erdosteine is usually very well tolerated, with rare occurrences of gastrointestinal issues such as heartburn, nausea, or diarrhea, and potentially allergic reactions. Apart from children weighing < 15 kg, erdosteine is not suitable for patients with severe liver and kidney dysfunctions and those with homocystinuria.
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Sources:
1. Kotolová H. The Possibilities of Influencing Acute Cough in the Context of Respiratory Infections in Children. Pediatrics for Practice 2020; 21 (5): 315−319.
2. Bittenglová R. Erdosteine − Antibacterial Mucolytic. Medicine for Practice 2006; 1: 43−44.
3. ERICA Registry, 2014−2018. Available at: www.registry.cz/index.php?pg=registry--vsechny&prid=24
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