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Ear/Eye/Nose drops containing betamethasone sodium phosphate 0.1% w/v.

Drugs List

  • betamethasone 0.1% drops
  • BETNESOL 0.1% eye/ear/nose drops
  • VISTA-METHASONE 0.1% drops
  • Therapeutic Indications


    Short-term treatment of steroid responsive inflammatory conditions of the eye after clinical exclusion of bacterial, viral and fungal infections.

    Non-infected inflammatory conditions of the ear or nose.


    The frequency of dosing depends on the clinical response. If there is no clinical response within 7 days of treatment, the drops should be discontinued.

    Treatment should be the lowest effective dose for the shortest possible time. After more prolonged treatment (over 6 to 8 weeks), the drops should be withdrawn slowly to avoid relapse.


    Instil 1 or 2 drops into the affected eye(s) every one or two hours until control is achieved, frequency of dosing may then be reduced.

    Instil 2 or 3 drops into the affected ear(s) every two or three hours until control is achieved, frequency of dosing may then be reduced.

    Instil 2 or 3 drops into each nostril two or three times daily.


    No dosage adjustment necessary ( see Dosage-Adult ).


    No dosage adjustment necessary ( see Dosage-Adult ).

    Prolonged use may lead to the risk of adrenal suppression in infants.


    Bacterial, viral, fungal, tuberculous or purulent conditions of the eye
    Herpetic keratitis (e.g. dendritic ulcer)
    Undiagnosed red eye
    Perforated tympanic membrane

    Solution contains benzalkonium chloride and is therefore contraindicated for soft contact lens wearers

    Precautions and Warnings

    Prolonged use in infants may cause adrenal suppression.

    The medication may cause transient blurring of vision on instillation into the eye. Patients should be warned not to drive or operate hazardous machinery unless vision is clear.

    Nasal administration of corticosteroids is not advised if the patient has pulmonary tuberculosis or following nasal surgery (until healing has occurred).

    It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, referral to a paediatrician should be considered.

    Corticosteroid treatment should not be repeated without regular review to exclude raised intraocular pressure, cataract formation or infections.

    Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral and fungal infections and mask the clinical signs of infections, preventing recognition of ineffectiveness of the antibiotic. In these cases, antibiotic therapy is mandatory.

    Fungal infection should be suspected in any persistent corneal ulceration where a steroid has been used, or is in use and corticosteroid therapy discontinued if fungal infection confirmed.

    Patients should not to wear contact lenses during treatment as they increase the chance of infection.

    Pregnancy - safety not established ( see Pregnancy ).

    Breastfeeding - safety not established ( see Lactation ).

    Pregnancy and Lactation


    The safety of the use of betamethasone eye drops in pregnancy has not been established.

    Topical administration of corticosteroids to pregnant animals can cause abnormalities in foetal development, including cleft palate, interuterine growth retardation, low birth weight and reduced head circumference at birth. There may be a 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 ( ).


    The safety of the use of betamethasone eye drops in nursing mothers has not been established.

    At the time of writing, no reports of the use of betamethasone drops by a nursing mother have been located.

    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

    Effects on Ability to Drive and Operate Machinery

    The ability to drive or operate machinery may be affected by transient blurring of vision. Patients should be warned not to drive or operate machinery unless vision is clear.


    The ability to drive or operate machinery may be affected by transient blurring of vision. Advise patient not to drive or operate machinery unless vision is clear.

    Side Effects

    Hypersensitivity reactions
    Local irritation
    Itching sensation
    Burning sensation
    Corneal ulceration
    Increased intraocular pressure
    Optic nerve damage
    Reduced visual acuity
    Visual field damage
    Posterior subcapsular cataracts
    Thinning of the ocular globe
    Perforation of the ocular globe
    Local irritation
    Epithelial punctate keratitis
    Irritation of nasal mucosa
    Nasal dryness
    Perforation of nasal septum
    Rebound congestion
    Taste disturbances
    Ulceration of the nasal septum

    Systemic effects of corticosteroids, particularly with high doses prescribed for a long period may include:
    Growth retardation (children)
    Adrenal suppression (infants)
    Cushing's syndrome
    Cushingoid features


    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 ( ).

    Shelf Life and Storage

    Store below 25 degrees C.
    Do not freeze.
    Keep container in outer carton.

    Further Information

    Last Full Review Date: December 2011

    Reference Sources

    British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

    BNF for Children (2011-2012) Pharmaceutical Press, London.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Betnesol eye, ear and nose drops. UCB Pharma Ltd. Revised April 2011.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Betamethasone Last revised: July 5, 2011
    Last accessed: December 28, 2011

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

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