Oxymetazoline

Generic name
Oxymetazoline
Brand name
ATC Code
R01AA05
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Oxymetazoline

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The effect of oxymetazoline begins within a few minutes. Occasionally, when administered intranasally, the amount absorbed may be sufficient to cause systemic effects for example at the central nervous system and the cardiovascular system. Further data from pharmacokinetic studies in humans are not available. (Merck, SmPC Nasivin® Nasenspray ohne Konservierungsstoffe Kleinkinder (6109145.00.00))

 

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
    • Nose drops, solution
      • 1 month up to 2 years
        • 0.01%: in each nostril
           1           drop(s)/dose, as required 1-3 times daily.
        • Duration of treatment:

          Maximum 7 days

          • Minimal dose interval: 8 hours
          • 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.
          • There is only limited scientific evidence for using oxymetazoline in this age category.
             
      • 2 years up to 6 years
        • 0.025%: in each nostril 1 drop(s)/dose, as required 1-3 times daily.
        • Duration of treatment:

          Maximum 7 days

        • Minimal dose interval: 8 hours

      • Term neonate
        • 0.01%: in each nostril
           1           drop(s)/dose, as required 1-3 times daily.
        • Duration of treatment:

          Maximum 7 days

          • Minimal dose interval: 8 hours
          • 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.
          • There is only limited scientific evidence for using oxymetazoline in this age category.
             
    • Nasal spray, solution
      • ≥ 6 years
        • 0.05% in each nostril 1 puff(s)/dose 1-3x daily, maximum 4-6x daily.
        • Duration of treatment:

          Maximum 7 days

      • 1 year up to 6 years
        • 0.025%: in each nostril: 1 puff(s)/dose, as required 1-3x daily,.
        • Duration of treatment:

          Maximum 7 days

        • Minimal dose interval: 8 hours.

      • ≥ 6 years
        [4]
        • 0.05% in each nostril 1 puff(s)/dose 1-3x daily, maximum 4-6x daily.
        • Duration of treatment:

          Maximum 7 days

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 oxymetazoline. Side effects that can occur are heart palpitations, hypertension and nervousness, sleep disorders, very rarely hallucinations and convulsions. Very rarely apnea in newborns and young infants (SmPC Nasiben).

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

Contra-indications

No information available on specific contra indications in children.

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

Intranasal absorption can in rare cases lead to systemic effects.

In infants and children up to 6 years excessive use of oxymetazoline can lead to toxic effects such as loss of consciousness and symptomatic hypotension. Such an overdose can cause severe depression of the central nervous system in toddlers and young children.

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.

Sympathomimetics, plain
R01AA08
R01AA09
R01AA07
Sympathomimetics, combinations excl. corticosteroids
R01AB01
Antiallergic agents, excl. corticosteroids
R01AC03
R01AC01
R01AC02
Corticosteroids
R01AD58
R01AD01
R01AD05
R01AD08
R01AD12
R01AD12
R01AD09
R01AD59
R01AD11
Other nasal preparations
R01AX10
OTHER NASAL PREPARATIONS
R01AX10

References

  1. CHMP, EPAR Oxymetazolin, www.ema.europa.eu
  2. Merck Selbstmedikation GmbH, SmPC Nasivin 0,025% (RVG 26124) 16-05-2011, www.geneesmiddeleninformatiebank.nl
  3. Merck Selbstmedikation GmbH, SmPC Nasivin 0,01% (RVG 29857) 16-05-2011, www.geneesmiddeleninformatiebank.nl
  4. Merck Selbstmedikation GmbH, SmPC Nasivin 0,05% (RVG 00848/00849/19073) 16-05-2011, www.geneesmiddeleninformatiebank.nl
  5. WICK Pharma, SmPC WICK Sinex Schnupfenspray 0,5 mg/ml (Reg.-Nr. 48887), 02/2015
  6. WICK Pharma, SmPC WICK Sinex avera Nasenspray 0,5 mg/ml (50661.00.00), 09/2017
  7. Merck Selbstmedikation, SmPC Nasivin® Nasenspray ohne Konservierungsstoffe Erwachsene und Schulkinder (3494.00.01), 02/2017
  8. Merck Selbstmedikation, SmPC Nasivin® Nasentropfen/Spray/Dosierspray für Erwachsene und Schulkinder (6108938.00.01/ 6108938.00.00/ 6462346.00.00), 05/2014
  9. Merck Selbstmedikation, SmPC Nasivin® Nasenspray ohne Konservierungsstoffe Kleinkinder (6109145.00.00), 03/2017
  10. Merck Selbstmedikation, SmPC Nasivin® Dosiertropfer ohne Konservierungsstoffe Baby (6109145.01.00), 03/2017
  11. P&G Health Germany, SmPC Nasiben Baby sanft 0,01%-Dosiertropfer (1-27063), https://aspregister.basg.gv.at/, aufgerufen am 22.01.2021

Changes

Therapeutic Drug Monitoring


Overdose