Drugs List

Therapeutic Indications

Uses

Infected dermatoses responsive to topical corticosteroids

Infected dermatoses responsive to topical corticosteroids where candidal or bacterial infection is present, suspected or likely including:
Infected eczema
Intertrigo
Nappy rash
Anogenital pruritus
Seborrhoeic dermatitis

Contraindications

Acne vulgaris
Perioral dermatitis
Rosacea

Precautions and Warnings

Breastfeeding
Pregnancy

May mask symptoms or signs of infections
Exclude viral infection before treatment
Avoid contact with eyes
Avoid prolonged application to the face
Cleanse skin thoroughly before applying occlusive dressings
Do not dilute
Risk of glaucoma if preparation enters eye
Consider pseudomembranous colitis if patient presents with severe diarrhoea
Adrenal suppression can occur in infants even without occlusion
Long term use may cause adrenal suppression
Prolonged use may cause atrophic skin changes
Rebound effect may occur after cessation of treatment
Discontinue at once if pseudomembranous colitis occurs
Discontinue if hypersensitivity reactions occur
Discontinue therapy and use antimicrobials if secondary infection occurs
Avoid long-term use particularly in infants and children
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
Stains clothes and skin
Stains hair

Pregnancy and Lactation

Pregnancy

Use topical clobetasone with oxytetracycline and nystatin with caution during pregnancy.
The manufacturer advises that use of clobetasone with oxytetracycline and nystatin should only be considered if the benefit to the mother outweighs the risk to the foetus.
It is recommended to avoid using large amounts and for long periods of time if possible.
Topical application of corticosteroids to pregnant animals can cause abnormalities of foetal development but the relevance to humans is unclear.

Lactation

Use topical clobetasone with oxytetracycline and nystatin with caution during breastfeeding.
The manufacturer advises that clobetasone with oxytetracycline and nystatin should only be used if the expected benefit to the mother outweighs the risk to the infant. The product should not be applied to the breasts to avoid ingestion by the infant.
If applied to the breast area, the area should be washed and dried prior to breastfeeding and the preparation applied afterwards.

Side Effects

Acne (at application site)
Adrenal suppression
Allergic contact dermatitis
Atrophy (localised)
Burning sensation (local)
Cushing's syndrome
Erythema
Exacerbation of psoriasis
Exacerbation of symptoms
Hypersensitivity reactions
Hypertrichosis
Perioral dermatitis
Pruritus
Pseudomembranous colitis
Rash
Skin pigmentation changes
Striae (irreversible)
Thinning of skin
Urticaria

Presentation

Topical formulation containing clobetasone butyrate, oxytetracycline (as calcium oxytetracycline) and nystatin.

Drugs List

Therapeutic Indications

Uses

Infected dermatoses responsive to topical corticosteroids

Infected dermatoses responsive to topical corticosteroids where candidal or bacterial infection is present, suspected or likely including:
Infected eczema
Intertrigo
Nappy rash
Anogenital pruritus
Seborrhoeic dermatitis

Dosage

Adults

Children

Contraindications

Acne vulgaris
Perioral dermatitis
Rosacea

Precautions and Warnings

Breastfeeding
Pregnancy

May mask symptoms or signs of infections
Exclude viral infection before treatment
Avoid contact with eyes
Avoid prolonged application to the face
Cleanse skin thoroughly before applying occlusive dressings
Do not dilute
Risk of glaucoma if preparation enters eye
Consider pseudomembranous colitis if patient presents with severe diarrhoea
Adrenal suppression can occur in infants even without occlusion
Long term use may cause adrenal suppression
Prolonged use may cause atrophic skin changes
Rebound effect may occur after cessation of treatment
Discontinue at once if pseudomembranous colitis occurs
Discontinue if hypersensitivity reactions occur
Discontinue therapy and use antimicrobials if secondary infection occurs
Avoid long-term use particularly in infants and children
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
Stains clothes and skin
Stains hair

Pregnancy and Lactation

Pregnancy

Use topical clobetasone with oxytetracycline and nystatin with caution during pregnancy.
The manufacturer advises that use of clobetasone with oxytetracycline and nystatin should only be considered if the benefit to the mother outweighs the risk to the foetus.
It is recommended to avoid using large amounts and for long periods of time if possible.
Topical application of corticosteroids to pregnant animals can cause abnormalities of foetal development but the relevance to humans is unclear.

Lactation

Use topical clobetasone with oxytetracycline and nystatin with caution during breastfeeding.
The manufacturer advises that clobetasone with oxytetracycline and nystatin should only be used if the expected benefit to the mother outweighs the risk to the infant. The product should not be applied to the breasts to avoid ingestion by the infant.
If applied to the breast area, the area should be washed and dried prior to breastfeeding and the preparation applied afterwards.

Counselling

Advise patients to wash their hands after applying clobetasone with oxytetracycline and nystatin, unless it is the hands that are being treated.

Advise patients residue on clothing/bedding may cause a fire hazard.

Advise the patient that the product may stain skin, hair and clothes.

Avoid contact with eyes.

Side Effects

Acne (at application site)
Adrenal suppression
Allergic contact dermatitis
Atrophy (localised)
Burning sensation (local)
Cushing's syndrome
Erythema
Exacerbation of psoriasis
Exacerbation of symptoms
Hypersensitivity reactions
Hypertrichosis
Perioral dermatitis
Pruritus
Pseudomembranous colitis
Rash
Skin pigmentation changes
Striae (irreversible)
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: January 2019

Reference Sources

Summary of Product Characteristics: Trimovate. Ennogen Healthcare Ltd. Revised November 2017.