Polymyxine B + neomycine + hydrocortison (Combinatie preparaat)

Generic name
Polymyxine B + neomycine + hydrocortison (Combinatie preparaat)
Brand name
ATC Code
S02CA03
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Polymyxine B + neomycine + hydrocortison (Combinatie preparaat)

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Geen informatie

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

< 2 jaar: Off-label
≥ 2 jaar: On-label

Licensed use Licensed use

Registration Status Title

Otitis externa:
≥ 2 jaar: 3-4 dd 3 druppels.

Available formulations

Per ml oordr.:
Hydrocortison 10 mg, Neomycinesulfaat 5 mg, Polymyxine-B-sulfaat 10000 IE, 10 ml

Dosages

Otorrhoea in middle ear inflammation with the presence of perforation or tube
  • Auricular
    • 6 weeks up to 2 years
      • 1 - 2 drop(s)/dose 3-4 dd.
      • Duration of treatment:

        Maximaal 14 dagen

    • 2 years up to 18 years
      • 2 - 3 drop(s)/dose 3-4 dd.
      • Duration of treatment:

        Maximaal 14 dagen

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

Adult Side Effects

Stekend en branderig gevoel bij geperforeerd trommelvlies. Overgevoeligheidsverschijnselen. Neomycine kan frequent en polymyxine in mindere mate sensibilisatie veroorzaken. Ototoxiciteit (bij systemische resorptie). Langdurig gebruik van corticosteroïden in het oor kan leiden tot atrofie en perforatie van het trommelvlies.

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

Contra-indications in adults

Beschadiging/perforatie van het trommelvlies of vermoeden hiervan. Aandoeningen, primair veroorzaakt door een bacterie, virus, schimmel, gist of parasiet. Ulcereuze aandoeningen, wonden. Neonaten. Overgevoeligheid voor aminoglycosiden en polymyxinen.

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

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

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

CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION

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 and antiinfectives in combination
S02CA03
S02CA03
S02CA06
S02CA07
S02CA07
S02CA03
S02CA04

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. GlaxoSmithKline BV, SPC Otosporin (RVG 00855) 8-3-2016, www.geneesmiddeleninformatiebank.nl, Geraadpleegd 28 okt 2016

Changes

Therapeutic Drug Monitoring


Overdose