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Flumetasone pivalate with clioquinol auricular


Ear drops containing flumetasone pivalate and clioquinol

Drugs List

  • flumetasone 0.02% and clioquinol 1% ear drops
  • Therapeutic Indications


    Otitis externa - infective



    Instil 2 or 3 drops into the auditory canal of the affected ear twice daily.


    Instil 2 or 3 drops into the auditory canal of the affected ear twice daily.


    Children aged 2 years and over
    Instil 2 or 3 drops into the auditory canal of the affected ear twice daily.

    Children under 2 years of age
    Not recommended.


    Children under 2 years
    Perforated tympanic membrane

    Precautions and Warnings


    Avoid contact with eyes
    If no improvement after 7 days: initiate appropriate antimicrobial therapy
    Long term use may cause adrenal suppression
    May interfere with thyroid function tests
    Discontinue if irritation or sensitisation occur
    Length of treatment should not exceed 10 days

    Not for use in primary bacterial, viral or fungal infections of the outer ear.

    Topical application of clioquinol may lead to a marked increase in protein-bound iodine affecting the results of thyroid function tests for protein bound iodine, radioactive iodine and butanol-extractable iodine. Other thyroid function tests such as the T3 resin sponge test or T4 determination are not affected.

    The ferric chloride test of phenylketonuria may yield a false-positive result when clioquinol is present in the urine. The product should not, therefore, be allowed to come into contact with the conjunctiva.

    Pregnancy and Lactation


    Caution is advised in pregnancy.

    The manufacturer notes that there is inadequate evidence of safety in human pregnancy.

    In animals, topical administration of corticosteroids can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may, therefore, be a very small risk of such effects in the human foetus.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Caution is advised in pregnancy.

    The manufacturer notes that use in lactating mothers should only be at the doctor's discretion. It is not known whether the active substances pass into breast milk after topical administration.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Burning sensation (local)
    Discolouration of hair
    Hypersensitivity reactions
    Irritation (localised)
    Itching sensation (local)


    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: July 2013

    Reference Sources

    British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

    BNF for Children (2012-2013) Pharmaceutical Press, London.

    Summary of Product Characteristics: Locorten-Vioform Ear Drops. Amdipharm Mercury COmpany Limited. Revised June 2006.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.