- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
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
| Chronic recurrent middle ear inflammation with otorrhoea |
|---|
|
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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
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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. Long-term use in children can lead to the suppression of the production of adrenal cortex hormones.
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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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| Corticosteroids and antiinfectives in combination | ||
|---|---|---|
| S02CA03 | ||
| S02CA03 | ||
| S02CA07 | ||
| S02CA07 | ||
| S02CA03 | ||
| S02CA03 | ||
| S02CA04 | ||
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References
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- Mylanus E.A.M. et al, Standpunt nota \"Gebruik van oordruppels bij otitis media met trommelvliesperforatie en in operatieholtes\", Nederlandse Vereniging voor KNO en heelkunde van het hoofdhals gebied, 2006
- Sanofi Aventis Netherlands BV, SPC Sofradex (RVG 04961) 09-02-2015, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
