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Hydrocortisone, nystatin, dimeticone & benzalkonium chloride topical

Presentation

Topical formulation containing hydrocortisone, nystatin, dimeticone and benzalkonium chloride.

Drugs List

  • hydrocortisone with nystatin dimeticone and benzalkonium chloride cream
  • TIMODINE cream
  • Therapeutic Indications

    Uses

    Dermatoses
    Severe nappy rash

    Treatment of dermatoses, including intertrigo, eczema, seborrhoeic dermatitis, hand dermatitis and pruritis ani et vulvae, in which infection with Candida albicans is a factor. Treatment of severe nappy rash in which infection with Candida albicans is a factor.

    Dosage

    Adults

    Dermatoses
    Apply a thin layer of the cream to the affected area three times a day until the lesion has healed.

    Children

    Dermatoses
    Apply a thin layer of the cream to the affected area three times a day until the lesion has healed.

    Nappy rash
    Apply a thin layer of cream and repeat after every nappy change. A course of treatment should not normally exceed seven days.

    Contraindications

    Acne vulgaris
    Perioral dermatitis
    Rosacea
    Skin infection
    Skin ulcer

    Precautions and Warnings

    Neonates
    Occlusive dressings
    Breastfeeding
    Pregnancy

    Exclude bacterial infection before treatment
    Exclude fungal infection before treatment
    Exclude viral infection before treatment
    Avoid application to broken skin
    Avoid contact with eyes
    Avoid prolonged application to the face
    Breastfeeding: Wash product off breasts prior to breastfeeding infant
    Occlusion may cause increased absorption
    Adrenal suppression can occur in infants even without occlusion
    Elderly patients may be more susceptible to local and systemic effects
    Potential for withdrawal symptoms
    Rebound effect may occur after cessation of treatment
    Discontinue if hypersensitivity reactions occur
    Avoid long-term use particularly in infants and children
    Maximum duration of treatment 7 days in infants
    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

    Rarely, severe skin reactions and adverse effects may occur on stopping treatment with topical corticosteroids. Consider the lowest potency required and counsel patient on safe and effective use.

    Topical corticosteroids are not recommended for acne vulgaris, may worsen secondary infected lesions, and should not be used indiscriminately in pruritis.

    Pregnancy and Lactation

    Pregnancy

    Use the combination of hydrocortisone with nystatin, dimeticone and benzalkonium chloride with caution during pregnancy.

    The manufacturer advises caution if this product is used during pregnancy. Topical administration of corticosteroids to pregnant animals may cause abnormalities of foetal development. At the time of writing there is limited published information regarding the use of this product during pregnancy. Potential risks are unknown. Topical steroids should not be used in large amounts or for prolonged periods during pregnancy.

    Lactation

    Use hydrocortisone with nystatin, dimeticone and benzalkonium chloride with caution during breastfeeding.

    The manufacturer advises caution if this product is used during breastfeeding and that the cream should be wiped off thoroughly before breastfeeding if it has been applied to the breast or nipple areas. Although poorly absorbed, it is unknown if nystatin enters breast milk. Corticosteroids cross the placenta in different degrees and can be distributed in small amounts in breast milk.

    Side Effects

    Acne
    Adrenal suppression
    Contact dermatitis
    Contact sensitisation
    Cushing's syndrome
    Exacerbation of acne
    Exacerbation of infection
    Hypersensitivity reactions
    Hypertrichosis
    Perioral dermatitis
    Purpura
    Rosacea
    Skin depigmentation
    Striae (irreversible)
    Subcutaneous atrophy
    Telangiectasia
    Thinning of skin

    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: March 2020

    Reference Sources

    Summary of Product Characteristics: Timodine Cream. Alliance Pharmaceuticals Limited. Revised November 2021.

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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.