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Dexamethasone and neomycin and acetic acid auricular


Liquid ear spray containing neomycin sulfate with dexamethasone and glacial acetic acid.

Drugs List

  • dexamethasone 0.1% and neomycin 0.5% and acetic acid 2% ear spray
  • OTOMIZE ear spray
  • Therapeutic Indications


    Otitis externa



    Apply 1 metered dose spray (60mg) into each affected ear three times a day.


    Children aged 2 years and over:
    Apply 1 metered dose spray (60mg) into each affected ear three times a day.


    Children under 2 years
    Perforated tympanic membrane

    Precautions and Warnings

    Hepatic impairment
    Otitis media
    Renal impairment

    Do not use if tympanostomy tube (grommet) is in situ
    Exclude tympanic membrane perforation before initiating treatment
    May mask symptoms or signs of infections
    Advise visual disturbances may affect ability to drive or operate machinery
    Contains hydroxybenzoate
    Do not apply to broken or denuded skin
    Do not inhale the spray
    If visual disturbances occur, perform ophthalmic evaluation
    Paediatric patients may be more susceptible to systemic toxicity
    Advise patient to report signs of deafness
    Discontinue if no improvement occurs within 7 days
    Discontinue treatment if skin rash or other allergic reaction occurs
    Avoid prolonged use
    Continue treatment for at least 2 days after symptoms resolve

    Pregnancy and Lactation


    Dexamethasone, neomycin and acetic acid is contraindicated during pregnancy.

    The effects of using dexamethasone, neomycin and acetic acid as a combined product during pregnancy are unknown. Use is not recommended by the manufacturer.

    Known effects of dexamethasone during pregnancy
    Dexamethasone crosses the placenta to the foetus. Leukocytosis has been observed in infants exposed antenatally to dexamethasone. The white blood cell counts returned to normal in about a week. Systemic absorption of dexamethasone may also occur. Foetal abnormalities including cleft palate and intra-uterine growth retardation, have been observed in pregnant animals from topical application, the relevance of this finding to humans however has not been established (Briggs 2015).

    Known effects of neomycin during pregnancy
    Ototoxicity known to occur with oral, topical and parenteral neomycin has not been reported as an effect in utero however, eighth cranial nerve toxicity in the foetus is known following exposure to kanamycin and streptomycin and may potentially occur with neomycin. No evidence was found in 30 mother-child pairs having 1st trimester exposure to neomycin to suggest a relationship with malformations. It has been concluded that there is no detectable teratogenic risk of structural defects for any of the aminoglycoside antibiotics following a case-control pair analysis for 2nd and 3rd month of gestation (Briggs 2015).


    Dexamethasone, neomycin and acetic acid is contraindicated during breastfeeding.

    The effects of using dexamethasone, neomycin and acetic acid as a combined product during breastfeeding are unknown. Breastfeeding is contraindicated by the manufacturer and a decision should be made whether to cease breastfeeding or stop taking the medication.

    Known effects of dexamethasone during breastfeeding
    Traces of dexamethasone may be secreted in human milk. It is not likely that the amount in milk would produce clinical effects unless used in high doses over prolonged periods (Hale 2010).

    Known effects of neomycin during breastfeeding
    No reports of use during human lactation are available although small amounts of gentamicin are excreted in breast milk and absorbed by the nursing infant. It is considered that given the very low oral bioavailability of neomycin, the amount in breast milk would not be clinically significant in the nursing infant. The safety of neomycin with regard to ototoxicity has not been established during breast feeding and it should be used with caution (Hale 2014).

    Side Effects

    Blurred vision
    Burning sensation (local)
    Contact dermatitis
    Hypersensitivity reactions
    Irritation (localised)
    Itching sensation (local)
    Skin sensitivity
    Visual disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2019

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Otomize Ear Spray, Teva UK Limited. Revised February 2018.

    NICE Evidence Services Available at: Last accessed: 12 March 2019

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