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

Interactions
PK
Renal impairment
References

Bacitracin + colistin + hydrocortisone (combination preparation)

Generic name
Bacitracin + colistin + hydrocortisone (combination preparation)
Brand name
ATC Code
S02CA03

Pharmacokinetics in children

No information

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

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Available formulations

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Dosages

Otorrhoea in middle ear inflammation with the presence of perforation or tube (see warning)
  • Auricular
    • 1 month up to 18 years
      • 5 drop(s)/dose 3 times daily.
      • Duration of treatment:

        Maximum 14 days

      • Directions for administration:

        Reconstitute the powder for eardrops with the accompanying solvent. The solution can be kept for 10 days. Shake vigorously before use.

      •  

         

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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

Side effects

No information is present at this moment.

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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

The use of topical agents when the middle ear is open involves a (mild) risk of ototoxicity leading to high-frequency hearing loss and vestibulotoxicity that can cause balance problems. Ototoxicity is very rare in clinical settings, estimated at 0.01-0.03%, and is clearly less common than perceptual hearing loss due to a chronically secreting middle ear inflammation. Swollen middle ear mucosa as a result of chronically secreting middle ear inflammation also protects the middle ear against the ototoxic components of the ear drops.

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Interactions

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

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References

  1. Mylanus E.A.M. et al, Standpunt nota \"Gebruik van oordruppels bij otitis media met trommelvliesperforatie en in operatieholtes\", 2006, Nederlandse Vereniging voor KNO en heelkunde van het hoof-halsgebied.
  2. Damoiseaux RAMJ et al., NHG-Standaard Otitis media acuta bij kinderen, Huisarts Wet, 2014, 57(12):, 648
  3. van Dongen et al., A trial of treatment for acute otorrhea in children with tympanostomy tubes, N Engl J Med, 2014, 370, 723-33

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Changes

Changes