What is the effectiveness of levodropropizine in the treatment of children's cough?

Mechanism of action

Levodropropizine is a peripherally acting antitussive; it is the levorotatory isomer of racemic dropropizine. It acts at the tracheobronchial level by inhibiting nociceptive C-fibers. It also shows affinity for H₁-histamine and alpha-adrenergic receptors, so its antitussive effects are accompanied by antiallergic and bronchospasmolytic effects. It does not bind to beta-adrenergic, muscarinic, or opioid receptors, resulting in significantly fewer side effects and better tolerability of the treatment compared to central antitussives.

Safety and tolerability

In available studies, levodropropizine has shown a very good safety profile in the pediatric population. As an enantiomer of the also peripherally acting dropropizine, it was discovered in the 1980s. According to available data, its safety profile appears more favorable, especially compared to opioids like dextromethorphan or dihydrocodeine, antihistamines, and decongestants. A reduced incidence of undesirable somnolence was observed compared to centrally acting antitussives and peripherally acting dropropizine.

Effectiveness

One of the largest observational studies to date was conducted in Italy and included 433 children with episodes of acute cough lasting less than 3 weeks, accompanying upper respiratory tract infection (De Blasio et al., 2012). Most participants were of preschool age (52% younger than 6 years, average age 6.2 years). In a subgroup of 161 children, the cough was rated as moderate to severe. From this subgroup, 60 children used central antitussives and 101 children used levodropropizine. A favorable effect on the intensity and frequency of the cough was observed with all drugs used; however, a significantly higher reduction in coughing was noted with levodropropizine, with a 47% reduction compared to 28% with central antitussives.

Another double-blind randomized study compared levodropropizine with dextromethorphan in children with bronchitis (Kim et al., 2002). The severity and frequency of the cough decreased more significantly in the group receiving levodropropizine, as early as 2-3 days.

An older double-blind randomized study (Banderali et al., 1995) compared levodropropizine and its isomer dropropizine. According to the study, the frequency of nighttime coughs and awakenings decreased, with no significant difference; however, drowsiness was observed twice as often with dropropizine. The greatest reduction in cough frequency was achieved with both drugs within 3 hours of administration.

Summary for practice

• Levodropropizine is an effective antitussive for both children and adults, with statistically better overall effectiveness compared to central antitussives in terms of reducing cough intensity and frequency and nighttime awakenings. The risk/benefit ratio for cough treatment is more favorable with this drug than with other antitussives. It is well tolerated by patients, with side effects occurring very rarely (incidence < 1/10,000).
• It is indicated for treating adults and children from 2 years of age. The effectiveness studies for children younger than 2 years have not been conducted adequately, so according to the current SPC, it should be administered with caution in this patient group.
• Levodropropizine is recommended to be taken between meals. The interval between doses should be at least 6 hours.

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Sources:
1. De Blasio F., Dicpinigaitis P. V., De Danieli G. et al. Efficacy of levodropropizine in pediatric cough. Pulm Pharmacol Ther 2012; 25 (5): 337-342, doi: 10.1016/j.pupt.2012.05.010.
2. Kotolová H. New possibilities in self-treatment of cough. Angis revue 2018; 11: 48.
3. SPC Levopront. Available at: www.sukl.cz/modules/medication/detail.php?code=0107231&tab=texts