Case report
Xylometazoline poisoning: A 40-fold nasal overdose caused by a compounding error in 3 children

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Abstract

The imidazoline derivative xylometazoline, an alpha-2-adrenergic agonist, is used as non-prescription nasal preparation due to its vasoconstrictive and decongestive properties. Especially in children, an overdose can quickly cause severe central nervous system depression and cardiovascular adverse effects. In three 3-year-old boys (triplets) a xylometazoline intoxication was diagnosed by toxicological analysis. On admission to an emergency unit all three children were still unresponsive. One triplet showed respiration of 15–20 breaths/min and required oxygen support (3 L/min) via face mask; his electrocardiogram revealed sinus bradycardia of 64 beats/min with supraventricular extrasystoles. However, no interventions were necessary except fluid management via intravenous lines. Eleven hours after the event, two of the triplets were awake but still not fully oriented. The third triplet woke up 20 h after instillation of nose drops. Intoxication was caused by a compounding error in a pharmacy resulting in a concentration 40 times above the adequate dosage for children. In general, physicians, pharmacists and the public should be educated about the toxicity of over-the-counter preparations.

Introduction

Xylometazoline is a vasoconstricting substance of the imidazoline group. Due to its primarily local α-adrenergic effect it is particularly suitable for topical use on the nasal mucous membranes. The drug causes vasoconstriction, reduces oedema, inhibits hyperaemia of the mucous membranes of the nasopharyngeal cavity, and decreases the amount of secretions. Indications are acute rhinitis of viral or bacterial aetiology, acute or chronic, exacerbating paranasal sinusitis, or allergic rhinitis. In patients with a common cold it provides fast and effective relief of nasal congestion and is well tolerated [1]. For the use in children, the nasal drops or sprays are available in different strengths. In Germany, 0.1% xylometazoline solutions are available for adults and at 0.05% for children (one drop per dose) over the counter.

The drug is instilled into each nostril: children between 4 months and 2 years of age one drop of a 0.05% solution every 8–12 h; children between 2 and 12 years old 2–3 drops or 1 spray of the 0.05% solution every 8–10 h, adults and children aged over 12 years 2–3 drops or 1 spray of the 0.1% solution every 8–10 h. As rarely occurring side effects irritation, burning, and dryness of the nasal mucosa are described.

Section snippets

Case report

Three 3-year-old male children were presented to an emergency unit after being found somnolent and unresponsive at home. Three hours prior to admission, each of the triplets had received 1–2 drops of specially compounded nasal drops. The bottle was labelled 0.5 g colloidal silver and 0.5 g xylometazoline per 10 mL aqua. The mother noted dizziness and pain after applying the nasal drops to herself. All children complained about nasal pain and fell asleep shortly after intake. Two hours later, the

Toxicological findings

All of the urine samples were tested for acidic, neutral and basic drugs by immunological methods (for amphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, and opiates) as well as by gas chromatography and liquid chromatography coupled with mass spectrometry and diode array detection. Additionally, the nose drop solution was analyzed according to a procedure previously described [2]. After a liquid–liquid extraction at pH 9 using dichloromethane the samples were

Discussion

The chemical-toxicological analyzes revealed the presence of xylometazoline in the applied nose drops as well as in the urine samples of all three children. Unfortunately, no blood samples were taken in the hospital. Therefore the intoxication was not ascertained by blood levels but only by the clinical symptoms and the appearance of xylometazoline in urine.

In the nose drop solution xylometazoline was found in a concentration of 20 mg/mL (2%) and therefore 40 fold higher than expected (0.05% is

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