This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Presentation

Topical formulations of clobetasol propionate with neomycin sulfate and nystatin

Drugs List

  • clobetasol 0.05% and neomycin 0.5% and nystatin 100000unit/g cream
  • clobetasol 0.05% and neomycin 0.5% and nystatin 100000unit/g ointment
  • Therapeutic Indications

    Uses

    Psoriasis- infected
    Recalcitrant eczema- infected

    Dosage

    Adults

    The preparation should be applied sparingly to the affected area, once or twice daily (up to a maximum of 50 g per week) until improvement occurs. Treatment should be discontinued when adequate control of symptoms has been achieved. In the case of more responsive conditions, this may be within a few days.

    In very resistant lesions, the effect of the preparation may be enhanced by occluding the treatment area with polythene. Overnight occlusion is usually adequate to bring about a satisfactory response.
    Thereafter, improvement can usually be maintained without occlusion.

    Treatment should not be continued for more than 7 days without medical supervision.
    If a longer course is necessary, it is recommended that treatment should not be continued for more than 4 weeks without the patient's condition being reviewed.

    Elderly

    (See Dosage; Adult).

    Caution should be used when treating elderly patients with impaired renal function and where significant systemic absorption is likely.

    Children

    Children greater than 2 years of age
    (See Dosage; Adult).

    Children less than 2 years of age
    Not recommended for use due to the possibility of increased absorption.

    Additional Dosage Information

    Treatment should be discontinued when condition control is achieved. In more responsive conditions, this may be within a few days.

    Repeat short courses of treatment may be used to control exacerbations.
    If continuous steroid treatment is necessary, a less potent preparation should be used.

    Contraindications

    Children under 2 years
    Acne vulgaris
    Genital pruritus
    Perianal pruritus
    Perioral dermatitis
    Rosacea

    Precautions and Warnings

    Breastfeeding
    Pregnancy
    Renal impairment

    Careful supervision of patients with psoriasis required
    May mask symptoms or signs of infections
    Potentially ototoxic and nephrotoxic-use with care in renal insufficiency
    Reduce dose in patients with renal impairment
    Exclude viral infection before treatment
    Contains arachis (peanut oil), soya or soya derivative
    Avoid contact with eyes
    Cleanse skin thoroughly before applying occlusive dressings
    If accidental contact with the eyes occurs, rinse thoroughly with water
    Perforated tympanic membrane - not for use in external auditory canal
    Risk of glaucoma if preparation enters eye
    Review therapy after 4 weeks
    Adrenal suppression may occur even without occlusion
    Extended or recurrent use may increase the risk of contact sensitisation
    Prolonged use may cause atrophic skin changes
    Risk of generalised pustular psoriasis with use of topical corticosteroids
    Discontinue if hypersensitivity reactions occur
    Discontinue treatment if infection spreads
    Avoid long-term use particularly in infants and children
    Limit use in infants or on face to 5 days and without occlusion
    Maximum treatment 7 days unless on doctor's advice
    Advise patient residue on clothing/bedding may cause fire hazard
    Fire hazard: Keep away from naked flames and potential sources of ignition
    Nappy may act as an occlusive dressing

    When treating conditions such as eczema or psoriasis, it should be noted that the face, more than other areas of the body may exhibit atrophic changes after prolonged treatment with potent topical steroids. Treatment courses should be limited to 5 days and occlusion should not be used.

    Impaired barrier function of the skin may result in exacerbation of symptoms, generalised pustular psoriasis, development of resistance to treatment or local/systemic toxicity. Relapse or rebound may occur upon withdrawal of treatment.

    Neomycin has nephrotic potential and can cause irreversible ototoxicity following significant systemic absorption. It is for these reasons that this preparation should not be used in large quantities or on a large area for prolonged periods of time.

    Pregnancy and Lactation

    Pregnancy

    Use clobetasol propionate with neomycin and nystatin with caution in pregnancy.

    Clobetasol propionate with neomycin and nystatin cream/ointment should be avoided if possible and if a lower potency steroid preparation can be used satisfactorily. Use may be justified in severe recalcitrant conditions provided the treatment time is brief and the area to be covered is not extensive. Once control has been established, treatment should be stepped down to a lower potency topical steroid preparation where continuing treatment is necessary.

    Topical administration of corticosteroids in pregnant animals produced adverse effects on foetal development such as cleft palate and intrauterine growth retardation (IUGR). There are some epidemiological studies and a meta-analysis of such studies which show a risk of oral clefts consistent with animals studies (Schaefer, 2007). However, according to Lee (2000), there is no convincing evidence that systemic corticosteroids increase congenital abnormalities in humans. Lee (2000) advises that high potency steroids such as clobetasol propionate should be avoided if possible during pregnancy.

    Neomycin rapidly crosses the placenta and although ototoxicity has not been reported as an effect of in utero exposure, eight cranial nerve toxicity in the foetus has been documented following exposure to kanamycin and streptomycin and may occur with neomycin. Foetal nephrotoxity is a theoretical risk but has not been reported in human pregnancy. Local application of aminoglycosides is permissible as systemic absorption is minimal (Schaefer, 2007).

    Nystatin is poorly absorbed and can be used without restriction in pregnancy.

    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 to 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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Use clobetasol propionate with neomycin and nystatin with caution in breastfeeding.

    High potency topical steroids should never be used on the nipple in breastfeeding women and caution is recommended if used on large areas of the body (Hale, 2010). It is important to ensure the infant's skin does not come into direct contact with the areas of skin that have been treated.

    Topical neomycin is expected to produce very low levels in breast milk and pose a negligible risk to the infant. An increase in the risk of diarrhoea in the infant should be borne in mind if the preparation is applied to the breast area.

    Nystatin is poorly absorbed and is considered compatible with breastfeeding.

    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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Side Effects

    Adrenal suppression
    Allergic contact dermatitis
    Burning sensation (local)
    Erythema
    Hypercortisolism
    Hypersensitivity reactions
    Hypertrichosis
    Pruritus
    Pustular psoriasis
    Rash
    Skin pigmentation changes
    Striae (irreversible)
    Superficial vascular dilation
    Thinning of skin
    Urticaria

    Overdosage

    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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: July 2015

    Reference Sources

    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.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on 7 July 2015.

    Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press Accessed on 7 July 2015.

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

    Summary of Product Characteristics: Clobetasol propionate/neomycin sulphate/nystatin 0.5mg/5mg/1000,000 IU/g cream. Chemidex Pharma Ltd. Revised November 2013
    Summary of Product Characteristics: Clobetasol propionate/neomycin sulphate/nystatin 0.5mg/5mg/1000,000 IU/g ointment. Chemidex Pharma Ltd. Revised November 2013

    Therapeutics in Pregnancy and Lactation (2000) Lee, A., Inch, S. and Finnigan, D. Radcliffe Medical Press, Abingdon.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Clobetasol Last revised: 10 March, 2015
    Last accessed: 7 July, 2015

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Neomycin Last revised: 10 March, 2015
    Last accessed: 7 July, 2015

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

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

    FDB Logo

    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.