Xylometazoline

Generic name
Xylometazoline
Brand name
ATC Code
R01AA07
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Xylometazoline

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The PK parameters in children are uknown. Xylometazoline is not identified in plasma after nasal administration. Due to the structure of xylometazoline, it is assumed that this substance penetrates well into the central nervous system. (Topf 2013)

In children younger than 2 years of age (especially neonates), caution should be exercised when using xylometazoline nasal drops or nasal spray because the resorbent mucosal surface area relative to body weight is much greater than in adults. (Dutch Poisoning informaton centre)

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Stuffy nose
  • Nasal
    • 1 year up to 2 years
      [2] [3] [4] [17]

      • 0,025%:  1 drop or 1 spray in each nostril, use  as needed 1-3 times daily.
        Minimal dose interval: 8 hours.

      • Duration of treatment:

        maximum 7 days

      • Caution is recommended when using decongestants in this age category. Only use in exceptional cases, for example when the blocked nose is seriously affecting the ability to drink.

    • 2 years up to 6 years
      [2] [8] [15]

      • 0.05%:  1-2 drops or 1 spray in each nostril, as needed 1-3 times daily.
        Minimal dose interval:8 hours

      • Duration of treatment:

        maximum 7 days

    • 6 years up to 12 years
      [2] [3] [8] [9] [15]

      • 0.05%: 2-4 drops or 1-2 sprays in each nostril, as needed 1-3 times daily.
        Minimal dose interval:8 hours

        Alternatively (ONLY WHEN APPLICABLE IN COUNTRY)
        0,1%: 1 drop or 1 spray in each nostril 1-3 times daily as needed, minimal dose interval 8 hours

      • Duration of treatment:

        Maximum 7 days

    • 12 years up to 18 years
      [2] [3] [7] [9] [11] [14]

      • 0.1%:  2-4 drops or 1-2 sprays in each nostril, as needed 1-3 times daily.
        MInimal dose interval: 8 hours.

      • Duration of treatment:

        maximum 7 days

    • 0 months up to 3 months
      [17] [19] [20]

      • Prescription only by pediatricians and ENT doctors
        0.025%:         1 droplet or 1 spray in each nostril,  1-3 times daily if needed. Minimal dosing interval: 8 hours.

      • Duration of treatment:

        3-5 days, max 7 days

      • Caution is recommended when using decongestants in this age category. Only use in exceptional cases, for example when the blocked nose is seriously affecting the ability to drink.

    • 3 months up to 1 year

      • 0,025%:  1 drop or 1 spray in each nostril, as needed 1-3 times daily.
        Minimal dose interval: 8 hours.

      • Duration of treatment:

        maximum 7 days

      • Caution is recommended when using decongestants in this age category. Only use in exceptional cases, for example when the blocked nose is seriously affecting the ability to drink.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Children are sensitive to xylometazoline. Side effects that can occur are heart palpitations, hypertension and nervousness.

Nose bleeds [van Stralen]

Especially in children (very rare): systemic side effects like hallucinations, apnoea in young infants and newborns, convulsions [SmPC nasal drops/spray/gel AL]

Systemic side effects occur mainly in children who use xylometazoline too frequently or in high doses, leading to severe depression of the central nervous system, cardiovascular and pulmonary systems or, conversely, stimulation of the central nervous system. Central nervous system stimulation is expressed in: fear, excitement, hallucinations, convulsions. Central nervous system depression manifests itself as: drop in body temperature, lethargy, somnolence, coma. Other symptoms may include miosis, mydriasis, sweating, paleness, cyanosis, palpitations and apnea. When central effects predominate, tachycardia and hypertension followed by bradycardia and hypotension, may be observed, especially in children.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Do not use Otrivin Menthol in children younger than 12 years.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In children less than 2 years of age (especially neonates), caution should be exercised in the use of xylometazoline nasal drops or nasal spray because the resorbent mucosal surface area relative to body weight is much greater than in adults. Also, young children are more sensitive to the effects of imidazoline derivatives on the central nervous, respiratory and cardiovascular systems.

Systemic side effects occur mainly in children who use xylometazoline too frequently or at high doses/concentrations. The clinical picture following intoxication with imidazoline derivatives can be confusing due to the occurrence of periods of hyperactivity alternating with periods of depression of the central nervous, cardiovascular and pulmonary systems. Symptoms include decrease in body temperature, lethargy, drowsiness and coma. Cardiovascular effects that may be seen initially are tachycardia and hypertension. This may be followed by bradycardia and hypotension, mainly in young children. Stimulation of the central nervous system may also occur, with effects such as anxiety and agitation. Other symptoms may include nausea and vomiting; miosis and mydriasis; signs of peripheral vasoconstriction such as sweating, pallor, cold or clammy skin and cyanosis; palpitations and respiratory depression; hallucinations and convulsions. 

If effects occur, it is generally within 30 minutes to 2 hours (max. 4 hours) after ingestion. Effects also occur quickly (within 30 minutes) after intra-nasal exposure. Symptoms usually disappear within 8 to 16 hours, but may persist longer (several days).
(Dutch Poisons Information Center)

Discontinue treatment if systemic side effects occur.

In children under 2 years of age, decongestants are not recommended due to possible occurrence of serious side effects. Use xylometazoline 0.025% only in exceptional cases, e.g. in cases of poor drinking that cannot be remedied with physiological saline solution.

Caution should be exercised in children with hypertension and arrhythmias.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Corticosteroids
R01AD05

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. GlaxoSmithKline Consumer Healthcare B.V., SPC Otrivin (RVG 23976/23968/23969/23970) 20-02-2019, www.cbg-meb.nl
  3. Venekamp RP et al, NHG-Standaard Acute rhinosinusitis(Derde herziening), Huisarts Wet , 2014, 57(10), 537
  4. Merck Selbstmedikation GmbH, SmPC Nasivin 0,025% (RVG 26124) 16-05-2011, , www.geneesmiddeleninformatiebank.nl
  5. ALIUD PHARMA® , SmPC Nasentropfen/-spray/gel AL (11049.00.00/ 11045.01.00/ 8845.00.00/ 11031.00.00/ 11037.00.01), 10/2014
  6. Ursapharm Arzneimittel , SmPC Xylo-COMOD (3004492.00.00), 08/2015
  7. Johnson & Johnson, SmPC Olynth® 0,1 % Schnupfen Lösung/ Schnupfen Dosierspray (6040471.01.00/ 6460123.01.00), 09/2014
  8. Johnson & Johnson , SmPC Olynth® 0,05 % Schnupfen Lösung/ Schnupfen Dosierspray (6040471.00.00/ 6460123.00.00), 09/2014
  9. Johnson & Johnson, SmPC Olynth® 0,05 %/0,1 % N Schnupfen Dosierspray ohne Konservierungsstoffe (26497.00.00/ 23128.00.00), 11/2014
  10. Chiesi, SmPC schnupfen endrine (7866.00.00/ 8400.00.00), 09/2015
  11. Ratiopharm, SmPC NasenTropfen-ratiopharm® Erwachsene (12647.00.00), 06/2016
  12. Ratiopharm, SmPC NasenTropfen-ratiopharm® Kinder (6599.00.00), 06/2016
  13. GlaxoSmithKline Consumer Healthcare , SmPC Otriven® gegen Schnupfen 0,1 % Einzeldosispipetten (4627.00.00), 10/2016
  14. GlaxoSmithKline Consumer Healthcare , SmPC Otriven® gegen Schnupfen 0,1 % Nasentropfen (4624.00.00), 06/2016
  15. GlaxoSmithKline Consumer Healthcare , SmPC Otriven® gegen Schnupfen 0,05 % Nasentropfen (4628.00.00), 06/2016
  16. GlaxoSmithKline Consumer Healthcare , SmPC Otriven gegen Schnupfen 0,025 % Nasentropfen (6095041.00.00), 11/2016
  17. GlaxoSmithKline Consumer Healthcare, SmPC Otriven gegen Schnupfen 0,025 % Nasentropfen (6095041.00.00), 08/2021
  18. GlaxoSmithKline Consumer Healthcare GmbH & Co, Otriven 0,025 % Nasentropfen (6095041.00.00), 08/2021
  19. van Stralen KJ, et al., Use of xylometazoline in hospitalised infants: is it safe? A retrospective cohort study, Arch Dis Child, 2023, 108(1), 62-6
  20. van Velzen AG, et al., A case series of xylometazoline overdose in children, Clin Toxicol (Phila), 2007, 45(3), 290-4
  21. UMC Utrecht - Nationaal Vergiftigingen Informatie Centrum, 'Xylometazoline' , https://www.vergiftigingen.info/f?p=300:1210:923035972031:::RP,1210,1040::, 20-09-2024

Changes

Therapeutic Drug Monitoring


Overdose